Pharmaceutical Jurisprudence V SEM

Unit 2: Drugs and Cosmetics Act, 1940 and its rules 1945

 Detailed study of Schedule G, H, M, N, P, T, U, V, X, Y, Part XII B, Sch F & DMR

(OA)
 Sale of Drugs – Wholesale, Retail sale and restricted license. Offences and penalties
 Labeling & Packing of drugs- General labeling requirements and specimen labels for
drugs and cosmetics, List of permitted colors. Offences and penalties.
 Administration of the Act and Rules –
o Drugs Technical Advisory Board,
o Central drugs Laboratory,
o Drugs Consultative Committee,
o Government drug analysts,
o Licensing authorities,
o controlling authorities,
o Drugs Inspectors
Schedules

The various schedules that had been included in The Drugs and Cosmetics Rules 1945 is
given in the following table

S.No. Schedule Details

1 Schedule A Various form set forth in the Drugs and Cosmetics Rules 1945
2 Schedule B Fees for test or analysis by the Central Drugs Laboratories or
State Drugs Laboratories
3 Schedule B (I) Fees for the test or analysis by the pharmacopoeial laboratory for
Indian medicine (PLIM) or the government analyst
4 Schedule C Biological and Special Products
5 Schedule C (I) Other Special Products like Drugs belonging to the Digitalis
group, Ergot etc
6 Schedule D Substances not intended for medical use, Substance can be used
both as articles of food as well as drugs such as powdered milk
etc., Custom made devices, and Drugs and cosmetics imported for
manufacture and export by units situated in Special Economic
Zones as notified by the Government of India from time to time.

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7 Schedule D (I) Information and undertaking required to be submitted by the
manufacturer or his authorized agent with the Application Form
for a Registration Certificate. The format shall be properly filled
in for each application in Form 40. The detailed information,
secret in nature, may be furnished on a Computer Floppy.
8 Schedule D (II) Information required to be submitted by the manufacturer or his
authorized agent with the Application Form for the registration of
a bulk drug/formulation/special product for its import into India.
The format shall be properly filled in and the detailed
information, secret in nature, may be furnished on a Computer
Floppy
9 Schedule D (III) Information and undertaking required to be submitted by the
manufacturer or his authorised importer/distributor/agent with the
application form for a registration certificate. (The format shall be
properly filled in for each application in form 42)
10 Schedule E (I) List of poisonous substances under the Ayurvedic (including
Siddha) and Unani Systems of Medicine
11 Schedule F Requirements for the functioning and operation of a blood bank
and / or for preparation of blood components. i.e. blood banks /
blood components
12 Schedule F (I) Part 1–Vaccines – Provisions Applicable to the Bacterial and
Viral vaccine
Part II –Antisera - Provisions Applicable to the production of all
Sera from Living Animals
Part III- Diagnostic Antigens - Provisions Applicable to the
Manufacture and Standardisation of Diagnostic Agents (Bacterial
Origin)
Part IV - General
13 Schedule F (II) Standards for surgical dressings
14 Schedule F (III) Standards for umbilical tapes
15 Schedule FF Standards for ophthalmic preparations.
16 Schedule G Preparations containing drug substances excluding those intended
for topical or external use.

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17 Schedule H Prescription Drugs
18 Schedule H (I) Preparations containing the drug substances like Alprozolam,
cefadinir etc and their salts excluding those intended for topical or
external use (except ophthalmic and ear or nose preparations)
19 Schedule I Omitted
20 Schedule J Diseases and ailments (by whatever name described) which a
drug may not purport to prevent or cure or make claims to prevent
or cure.
21 Schedule K Drugs falling under clause (b) (i) of Section 3 of the Drugs and
Cosmetics Act, not intended for medicinal use, Quinine and other
antimalarial drugs, Mechanical Contraceptives etc.
22 Schedule L Omitted
23 Schedule L (I) Good Laboratory Practices and Requirements of premises and
equipments
24 Schedule M Good Manufacturing Practices and requirements of premises,
plant and equipment for pharmaceutical products
25 Schedule M (I) Good Manufacturing Practices and requirements of premises,
plant and equipment for homoeopathic medicines
26 Schedule M (II) Requirements of factory premises for manufacture of cosmetics
27 Schedule M (III) Quality Management System –for notified medical devices and
in-vitro diagnostics
28 Schedule N List of minimum equipment for the efficient running of a
pharmacy
29 Schedule O Standard for Disinfectant Fluids
Part I - provision applicable to black fluids and white fluids
30 Schedule P Life period of drugs
31 Schedule P (I) Pack sizes of drugs
32 Schedule Q List Of Dyes, Colours and Pigments permitted to be used in
cosmetics and soaps.
33 Schedule R Standards for condoms made of rubber latex intended for single
use and other mechanical contraceptives
34 Schedule R (I) The medical devices shall conform to the Indian Standards laid

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down from time to time by the Bureau of Indian Standards.
35 Schedule S Standards for cosmetics
36 Schedule T Good Manufacturing Practices for Ayurvedic, Siddha And Unani
Medicines
37 Schedule TA Form for record of utilization of raw material by Ayurveda or
Siddha or Unani licensed manufacturing units during the financial
year
38 Schedule U Particulars to be shown in manufacturing records: tablets and
capsules, parenteral preparations etc.
39 Schedule U (I) Particulars to be shown in the manufacturing records: Raw
Materials
40 Schedule V Standards for patent or proprietary medicines
41 Schedule X Drugs like Amobarbital, Glutethimide, Pentobarbital etc.
42 Schedule Y Requirements and guidelines for permission to import and / or
manufacture of new drugs for sale or to undertake clinical trials

Schedule H

During the supply of any drug [other than those specified in Schedule X] on a prescription of
a Registered Medical Practitioner for the drug specified in Schedule H the name of the
manufacturer of the drug, its batch number and the date of expiry of potency, if any, should
be entered in the registered.

Substances specified in Schedule H shall not be sold by retail except on and in accordance
with the prescription of a Registered Medical Practitioner.

The supply of drugs specified in Schedule H to Registered Medical Practitioners, Hospitals,

Dispensaries and Nursing Homes shall be made only against the signed order in writing
which shall be preserved by the licensee for a period of two years.

The person dispensing a prescription containing a drug specified in Schedule H shall comply
with the following requirements.

(a) the prescription must not be dispensed more than once unless the prescriber has stated
thereon that it may be dispensed more than once;

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(b) if the prescription contains a direction that it may be dispensed a stated number of times
or at stated intervals it must not be dispensed otherwise than in accordance with the
directions;
(c) at the time of dispensing there must be noted on the prescription above the signature of
the prescriber the name and address of the seller and the date on which the prescription
is dispensed.

No person dispensing a prescription containing substances specified in Schedule H, may

supply any other preparation, whether containing the same substance or not, in lieu thereof.

No advertisement of the drugs specified in Schedule H shall be made except with the
previous sanction of the Central Government.

During the labelling of medicine the container of a medicine for internal use shall

1) if it contains a substance specified in Schedule H, be labelled with the symbol Rx and

conspicuously displayed on the left top corner of the label and be also labelled with the
following words:
Schedule H drug- Warning: To be sold by retail on the prescription of a Registered
Medical Practitioner only’,
2) if it contains a substance specified in Schedule H, and comes within the purview of the
Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) be labelled with
the symbol NRx which shall be in red and conspicuously displayed on the left top
corner of the label, and be also labelled with the following words:
Schedule H drug -Warning: To be sold by retail on the prescription of a Registered
Medical Practitioner only’,

List of Schedule H - Prescription Drugs

S.No. Drug Name

1. Abacavir
2. Abciximab
3. Acamprosate calcium
4. Acebutol hydrochloride
5. Aclarubicin

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Schedule M

This Schedule describes the Good Manufacturing Practices and requirements of premises,
plant and equipment for pharmaceutical products

To achieve the objectives each licensee shall evolve appropriate methodology, systems and
procedures which shall be documented and maintained for inspection and reference; and the
manufacturing premises shall be used exclusively for production of drugs and no other
manufacturing activity shall be undertaken therein except in respect of units licensed prior to
11th December, 2001.

Part 1 - Good Manufacturing Practices For Premises and Materials

General requirement:

Location and surroundings

The factory building(s) for manufacture of drugs shall be so situated and shall have such
measures as to avoid risk of contamination from external environment including open
sewage, drain, public lavatory or any factory which produce disagreeable or obnoxious odour
or fumes, excessive soot, dust, smoke, chemical or biological emissions.

Buildings and premises

The building(s) used for the factory shall be designed, constructed, adapted and maintained to
suit the manufacturing operations so as to permit production of drugs under hygienic
conditions. They shall conform to the conditions laid down in the Factories Act, 1948 (63 of
1948).

The premises used for manufacturing, processing, warehousing, packaging, labelling and
testing purposes shall be –

(i) compatible with other drug manufacturing operations that may be carried out in the
same or adjacent area / section;
(ii) adequately provided with working space to allow orderly and logical placement of
equipment, materials and movement of personnel so as to:
(a) avoid the risk of mix-up between different categories of drugs or with raw materials,
intermediates and in-process material;

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(b) avoid the possibilities of contamination and cross- contamination by providing
suitable mechanism;
(iii) Designed / constructed / maintained to prevent entry of insects, pests, birds, vermins
and rodents. Interior surface (walls, floors and ceilings) shall be smooth and free from
cracks, and permit easy cleaning, painting and disinfection;
(iv) air-conditioned, where prescribed for the operations and dosage forms under
production. The production and dispensing areas shall be well lighted, effectively
ventilated, with air control facilities and may have proper Air Handling Units (wherever
applicable) to maintain conditions including temperature and, wherever necessary,
humidity, as defined for the relevant product. These conditions shall be appropriate to
the category of drugs and nature of the operation. These shall also be suitable to the
comforts of the personnel working with protective clothing, products handled,
operations undertaken within them in relation to the external environment. These areas
shall be regularly monitored for compliance with required specifications;
(v) provided with drainage system, as specified for the various categories of products,
which shall be of adequate size and so designed as to prevent back- flow and/or prevent
insects and rodents entering the premises. Open channels shall be avoided in
manufacturing areas and, where provided, these shall be shallow to facilitate cleaning
and disinfection;
(vi) the walls and floors of the areas where manufacture of drugs is carried out shall be free
from cracks and open joints to avoid accumulation of dust. These shall be smooth,
washable, coved and shall permit easy and effective cleaning and disinfection. The
interior surfaces shall not shed particles. A periodical record of cleaning and painting of
the premises shall be maintained.

Water System

There shall be valid system for treatment of water drawn from own or any other source to
render it potable in accordance with standards specified by the Bureau of Indian Standards or
Local Municipality, as the case may be, so as to produce Purified Water conforming to
Pharmacopoeial specification. Purified Water so produced shall only be used for all the
operations except washing and cleaning operations where potable water may be used. Water
shall be stored in tanks, which do not adversely affect quality of water and ensure freedom

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from microbiological growth. The tank shall be cleaned periodically and records maintained
by the licensee in this behalf.

Disposal of waste

(i) The disposal of sewage and effluents (solid, liquid and gas) from the manufactory shall
be in conformity with the requirements of Environment Pollution Control Board.
(ii) All bio-medical waste shall be destroyed as per the provisions of the Bio- Medical
Waste (Management and Handling) Rules, 1996.
(iii) Additional precautions shall be taken for the storage and disposal of rejected drugs.
Records shall be maintained for all disposal of waste.
(iv) Provisions shall be made for the proper and safe storage of waste materials awaiting
disposal. Hazardous, toxic substances and flammable materials shall be stored in
suitably designed and segregated, enclosed areas in conformity with Central and State
Legislations.

Warehousing Area

(i) Adequate areas shall be designed to allow sufficient and orderly warehousing of
various categories of materials and products like starting and packaging materials,
intermediates, bulk and finished products, products in quarantine, released, rejected,
returned or recalled, machine and equipment spare parts and change items.
(ii) Warehousing areas shall be designed and adapted to ensure good storage conditions.
They shall be clean, dry and maintained with acceptable temperature limits. Where
special storage conditions are required (e.g. temperature, humidity), these shall be
provided, monitored and recorded. Storage areas shall have appropriate house-keeping
and rodent, pests and vermin control procedures and records maintained. Proper racks,
bins and platforms shall be provided for the storage of materials.
(iii) Receiving and dispatch bays shall protect materials and products from adverse weather
conditions.
(iv) Where quarantine status is ensured by warehousing in separate earmarked areas in the
same warehouse or store, these areas shall be clearly demarcated. Any system replacing
the physical quarantine, shall give equivalent assurance of segregation. Access to these
areas shall be restricted to authorized persons.

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(v) There shall be a separate sampling area in the warehousing area for active raw materials
and excipients. If sampling is performed in any other area, it shall be conducted in such
a way as to prevent contamination, cross-contamination and mix-up.
(vi) Segregation shall be provided for the storage of rejected, recalled or returned materials
or products. Such areas, materials or products shall be suitably marked and secured.
Access to these areas and materials shall be restricted.
(vii) Highly hazardous, poisonous and explosive materials such as narcotics, psychotropic
drugs and substances presenting potential risks of abuse, fire or explosion shall be
stored in safe and secure areas. Adequate fire protection measures shall be provided in
conformity with the rules of the concerned civic authority areas.
(viii) Printed packaging materials shall be stored in safe, separate and secure
(ix) Separate dispensing areas for β (Beta) lactum, Sex Hormones and Cytotoxic substances
or any such special categories of product shall be provided with proper supply of
filtered air and suitable measures for dust control to avoid contamination. Such areas
shall be under differential pressure.
(x) Sampling and dispensing of sterile materials shall be conducted under aseptic
conditions conforming to Grade A, which can also be performed in a dedicated area
within the manufacturing facility.
(xi) Regular checks shall be made to ensure adequate steps are taken against spillage,
breakage and leakage of containers.
(xii) Rodent treatments (Pest control) should be done regularly and at least once in a year
and record maintained.

Production area

(i) The production area shall be designed to allow the production preferably in uni-flow
and with logical sequence of operations.
(ii) In order to avoid the risk of corss-contamination, separate dedicated and self- contained
facilities shall be made available for the production of sensitive pharmaceutical
products like penicillin or biological preparations with live micro-organisms. Separate
dedicated facilities shall be provided for the manufacture of contamination causing and
potent products such as Beta-Lactum, Sex Hormones and Cytotoxic substances.
(iii) Working and in-process space shall be adequate to permit orderly and logical
positioning of equipment and materials and movement of personnel to avoid cross-

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contamination and to minimize risk of omission or wrong application of any
manufacturing and control measures.
(iv) Pipe-work, electrical fittings, ventilation openings and similar service lines shall be
designed, fixed and constructed to avoid 1[accumulation of dust]. Service lines shall
preferably be identified by colours and the nature of the supply and direction of the
flow shall be marked/indicated.

Ancillary Areas

(i) Rest and refreshment rooms shall be separate from other areas. These areas shall not
lead directly to the manufacturing and storage areas.
(ii) Facilities for changing, storing clothes and for washing and toilet purposes shall be
easily accessible and adequate for the number of users. Toilets, separate for males and
females, shall not be directly connected with production or storage areas. There shall be
written instructions for cleaning and disinfection of such areas.
(iii) Maintenance workshops shall be separate and away from production areas. Whenever
spares, changed parts and tools are stored in the production area, these shall be kept in
dedicated rooms or lockers. Tools and spare parts for use in sterile areas shall be
disinfected before these are carried inside the production areas.
(iv) Areas housing animals shall be isolated from other areas. The other requirements
regarding animal houses shall be those as prescribed in rule 150-C(3) of the Drugs and
Cosmetics Rules, 1945 which shall be adopted for production purposes.

Quality Control Area

(i) Quality Control Laboratories shall be independent of the production areas. Separate
areas shall be provided each for physico-chemical, biological, microbiological or radio-
isotope analysis. Separate instrument room with adequate area shall be provided for
sensitive and sophisticated instruments employed for analysis.
(ii) Quality Control Laboratories shall be designed appropriately for the operations to be
carried out in them. Adequate space shall be provided to avoid mix-ups and cross-
contamination. Sufficient and suitable storage space shall be provided for test samples,
retained samples, reference standards, reagents and records.
(iii) The design of the laboratory shall take into account the suitability of construction
materials and ventilation. Separate air handling units and other requirements shall be

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provided for biological, microbiological and radioisotopes testing areas. The laboratory
shall be provided with regular supply of water of appropriate quality for cleaning and
testing purposes.
(iv) Quality Control Laboratory shall be divided into separate sections i.e. for chemical,
microbiological and wherever required, biological testing. These shall have adequate
area for basic installation and for ancillary purposes. The microbiology section shall
have arrangements such as airlocks and laminar air flow work station, wherever
considered necessary.

Personnel

(i) The manufacture shall be conducted under the direct supervision of competent technical
staff with prescribed qualifications and practical experience in the relevant dosage form
and / or active pharmaceutical products.
(ii) The head of the Quality Control Laboratory shall be independent of the manufacturing
unit. The testing shall be conducted under the direct supervision of competent technical
staff who shall be whole time employees of the licensee.
(iii) Personnel for Quality Assurance and Quality Control operations shall be suitably
qualified and experienced.
(iv) Written duties of technical and Quality Control personnel shall be laid and followed
strictly.
(v) Number of personnel employed shall be adequate and in direct proportion to the
workload.
(vi) The licensee shall ensure in accordance with a written instruction that all personnel in
production area or into Quality Control Laboratories shall receive training appropriate
to the duties and responsibility assigned to them. They shall be provided with regular
in-service training.

Manufacturing Operations and Control

(i) All manufacturing operations shall be carried out under the supervision of technical
staff approved by the Licensing Authority. Each critical step in the process relating to
the selection, weighing and measuring of raw material addition during various stages
shall be performed by trained personnel under the direct personal supervision of
approved technical staff.

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The contents of all vessels and containers used in manufacture and storage during the
various manufacturing stages shall be conspicuously labelled with the name of the
product, batch number, batch size and stage of manufacture. Each label should be
initialled and dt. by the authorised technical staff.
Products not prepared under aseptic conditions are required to be free from pathogens
like Salmonella, Escherichia coli, Pyocyanea, etc.
(ii) Precautions against mix-up and cross-contamination:
(i) The licensee shall prevent mix-up and cross-contamination of drug material and
drug product (from environmental dust) by proper air-handling system, pressure
differential, segregation, status labelling and cleaning. Proper records and Standard
Operating Procedures thereof shall be maintained.
(ii) The licensee shall ensure processing of sensitive drugs like Beta-Lactum antibiotics,
sex hormones and cytotoxic substances in segregated areas or isolated production
areas within the building with independent air-handling unit and proper pressure
differentials. The effective segregation of these areas shall be validated with
adequate records of maintenance and services.
(iii) To prevent mix-ups during production stages, material under process shall be
conspicuously labelled to demonstrate their status. All equipment used for
production shall be labelled with their current status.
(iv) Packaging lines shall be independent and adequately segregated. It shall be ensured
that all left-overs of the previous packaging operations, including labels, cartons and
caps are cleared before the closing hour.
(v) Before packaging operations are begun, steps shall be taken to ensure that the work
area, packaging lines, printing machines, and other equipment are clean and free
from any products, materials and spillages. The line clearance shall be performed
according to an approximate check list and recorded.
(vi) The correct details of any printing (for example of batch numbers or expiry dates)
done separately or in the course of the packaging shall be rechecked at regular
intervals. All printing and overprinting shall be authorized in writing.
(vii) The manufacturing environment shall be maintained at the required levels of
temperature, humidity and cleanliness.
(viii) Authorised persons shall ensure change-over into specific uniforms before
undertaking any manufacturing operations including packaging.

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(ix) There shall be segregated secured areas for recalled or rejected material and for such
material which are to be reprocessed or recovered.

Raw Materials

(i) The licensee shall keep an inventory of all raw materials to be used at any stage of
manufacture of drugs and maintain records as per Schedule U.
(ii) All incoming materials shall be quarantined immediately after receipt or processing. All
materials shall be stored under appropriate conditions and in an orderly fashion to
permit batch segregation and stock rotation by a ‗first in/first expiry‘ – ‗first-out‘
principle. All incoming materials shall be checked to ensure that the consignment
corresponds to the order placed.
(iii) All incoming materials shall be purchased from approved sources under valid purchase
vouchers. Wherever possible, raw materials should be purchased directly from the
producers.
(iv) Authorized staff appointed by the licensee in this behalf, which may include personnel
from the Quality Control Department, shall examine each consignment on receipt and
shall check each container for integrity of package and seal. Damaged containers shall
be identified, recorded and segregated.
(v) If a single delivery of material is made up of different batches, each batch shall be
considered as a separate batch for sampling, testing and release.
(vi) Raw materials in the storage area shall be appropriately labelled. Labels shall be clearly
marked with the following information:
(a) designated name of the product and the internal code reference, where applicable,
and analytical reference number;
(b) manufacturer‘s name, address and batch number;
(c) the status of the contents (e.g. quarantine, under test, released, approved, rejected);
and
(d) the manufacturing date, expiry date and re-test date.
(vii) There shall be adequate separate areas for materials under test, approved and rejected
with arrangements and equipment to allow dry, clean and orderly placement of stored
materials and products, wherever necessary, under controlled temperature and
humidity.
(viii) Containers from which samples have been drawn shall be identified.

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(ix) Only raw materials which have been released by the Quality Control Department and
which are within their shelf-life shall be used. It shall be ensured that shelf life of
formulation product shall not exceed with that of active raw materials used.
(x) It shall be ensured that all the containers of raw materials are placed on the raised
platforms/racks and not placed directly on the floor.

Equipment

(i) Equipment shall be located, designed, constructed, adapted and maintained to suit the
operations to be carried out. The layout and design of the equipment shall aim to
minimise the risk of errors and permit effective cleaning and maintenance in order to
avoid cross-contamination, build-up of dust or dirt and, in general, any adverse effect
on the quality of products. Each equipment shall be provided with a logbook, wherever
necessary.
(ii) Balances and other measuring equipment of an appropriate range, accuracy and
precision shall be available in the raw material stores, production and in-process control
operations and these shall be calibrated and checked on a scheduled basis in accordance
with Standard Operating Procedures and records maintained.
(iii) The parts of the production equipment that come into contact with the product shall not
be reactive, additive or adsorptive to an extent that would affect the quality of the
product.
(iv) To avoid accidental contamination, wherever possible, non-toxic/edible grade
lubricants shall be used and the equipment shall be maintained in a way that lubricants
do not contaminate the products being produced.
(v) Defective equipment shall be removed from production and Quality Control areas or
appropriately labelled.

Documentation and Records

Documentation is an essential part of the Quality assurance system and, as such, shall be
related to all aspects of Good Manufacturing Practices (GMP). Its aim is to define the
specifications for all materials, method of manufacture and control, to ensure that all
personnel concerned with manufacture know the information necessary to decide whether or
not to release a batch of a drug for sale and to provide an audit trail that shall permit
investigation of the history of any suspected defective batch.

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(i) Documents designed, prepared, reviewed and controlled, wherever applicable, shall
comply with these rules.
(ii) Documents shall be approved, signed and dt. by appropriate and authorized persons.
(iii) Documents shall specify the title, nature and purpose. They shall be laid out in an
orderly fashion and be easy to check. Reproduced documents shall be clear and legible.
Documents shall be regularly reviewed and kept up to date. Any alteration made in the
entry of a document shall be signed and dt..
(iv) The records shall be made or completed at the time of each operation in such a way that
all significant activities concerning the manufacture of pharmaceutical products are
traceable. Records and associated Standard Operating Procedures (SOP) shall be
retained for at least one year after the expiry date of the finished product.
(v) Data may be recorded by electronic data processing systems or other reliable means,
but Master Formulae and detailed operating procedures relating to the system in use
shall also be available in a hard copy to facilitate checking of the accuracy of the
records. Wherever documentation is handled by electronic data processing methods,
authorized persons shall enter or modify data in the computer. There shall be record of
changes and deletions. Access shall be restricted by ‗passwords‘ or other means and
the result of entry of critical data shall be independently checked. Batch records
electronically stored shall be protected by a suitable back-up. During the period of
retention, all relevant data shall be readily available.

Labels and other Printed Materials

Labels are absolutely necessary for identification of the drugs and their use. The printing
shall be done in bright colours and in a legible manner. The label shall carry all the prescribed
details about the product.

(i) All containers and equipment shall bear appropriate labels. Different colour coded
labels shall be used to indicate the status of a product (for example under test,
approved, passed, rejected).
(ii) To avoid chance mix-up of printed packaging materials, product leaflets, relating to
different products, shall be stored separately.
(iii) Prior to release, all labels for containers, cartons and boxes and all circulars, inserts and
leaflets shall be examined by the Quality Control Department of the licensee.

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(iv) Prior to packaging and labelling of a given batch of a drug, it shall be ensured by the
licensee that samples are drawn from the bulk and duly tested, approved and released
by the quality control personnel.
(v) Records of receipt of all labelling and packaging materials shall be maintained for each
shipment received indicating receipt, control reference numbers and whether accepted
or rejected. Unused coded and damaged labels and packaging materials shall be
destroyed and recorded.
(vi) The label or accompanying document of reference standards and reference culture shall
indicate concentration, lot number, potency, date on which containers was first opened
and storage conditions, where appropriate.

Master Formula Records

There shall be Master Formula records relating to all manufacturing procedures for each
product and batch size to be manufactured. These shall be prepared and endorsed by the
competent technical staff i.e. head of production and quality control. The Master Formula
shall include: -

(a) the name of the product together with product reference code relating to its
specifications;
(b) the patent or proprietary name of the product along with the generic name, a description
of the dosage form, strength, composition of the product and batch size;
(c) name, quantity, and reference number of all the starting materials to be used. Mention
shall be made of any substance that may ‗disappear‘ in the course of processing.
(d) a statement of the expected final yield with the acceptable limits, and of relevant
intermediate yields, where applicable.
(e) a statement of the processing location and the principal equipment to be used.
(f) the methods, or reference to the methods, to be used for preparing the critical
equipments including cleaning, assembling, calibrating, sterilizing;
(g) detailed stepwise processing instructions and the time taken for each step;
(h) the instructions for in-process control with their limits;
(i) the requirements for storage conditions of the products, including the container,
labelling and special storage conditions where applicable;
(j) any special precautions to be observed; (k) packing details and specimen labels.

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Packing Records

There shall be authorised packaging instructions for each product, pack size and type. These
shall include or have a reference to the following: -

(i) name of the product;

(ii) description of the dosage form, strength and composition;
(iii) the pack size expressed in terms of the number of doses, weight or volume of the
product in the final container;
(iv) complete list of all the packaging materials required for a standard batch size, including
quantities, sizes and types with the code or reference number relating to the
specifications of each packaging material.;
(v) reproduction of the relevant printed packaging materials and specimens indicating
where batch number and expiry date of the product have been applied;
(vi) special precautions to be observed, including a careful examination of the area and
equipment in order to ascertain the line clearance before the operations begin.
(vii) description of the packaging operation, including any significant subsidiary operations
and equipment to be used;
(viii) details of in-process controls with instructions for sampling and acceptance; and
(ix) upon completion of the packing and labelling operation, a reconciliation shall be made
between number of labelling and packaging units issued, number of units labelled,
packed and excess returned or destroyed. Any significant or unusual discrepancy in the
numbers shall be carefully investigated before releasing the final batch.

Batch Packaging Records

(i) A batch packaging record shall be kept for each batch or part batch processed. It shall
be based on the relevant parts of the packaging instructions, and the method of
preparation of such records shall be designed to avoid transcription errors.
(ii) Before any packaging operation begins, check shall be made and recorded that the
equipment and the work stations are clear of the previous products, documents or
materials not required for the planned packaging operations, and that the equipment is
clean and suitable for use.

Batch Processing Records

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 Pharmaceutical Jurisprudence V SEM
(i) There shall be Batch Processing Record for each product. It shall be based on the
relevant parts of the currently approved Master Formula. The method of preparation of
such records included in the Master Formula shall be designed to avoid transcription
errors.
(ii) Before any processing begins, check shall be performed and recorded to ensure that the
equipment and work station are clear of previous products, documents or materials not
required for the planned process are removed and the equipment is clean and suitable
for use.
(iii) During processing, the following information shall be recorded at the time each action
is taken and the record shall be dt. and signed by the person responsible for the
processing operations: -
(a) the name of the product,
(b) the number of the batch being manufactured,
(c) dates and time of commencement, of significant intermediate stages and of
completion of production,
(d) initials of the operator of different significant steps of production and where
appropriate, of the person who checked each of these operations,
(e) the batch number and/or analytical control number as well as the quantities of each
starting material actually weighed,
(f) any relevant processing operation or event and major equipment used,
(g) a record of the in-process controls and the initials of the person(s) carrying them out,
and the results obtained,
(h) the amount of product obtained after different and critical stages of manufacture
(yield),
(i) comments or explanations for significant deviations from the expected yield limits
shall be given,
(j) notes on special problems including details, with signed authorization, for any
deviation from the Master Formula,
(k) addition of any recovered or reprocessed material with reference to recovery or
reprocessing stages.

Standard Operating Procedures (SOPs) and Records, regarding:

(i) Receipt of materials:

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 Pharmaceutical Jurisprudence V SEM
(a) There shall be written Standard Operating Procedures and records for the receipt of
each delivery of raw, primary and printed packaging material.
(b) The records of the receipts shall include;
a. the name of the material on the delivery note and the number of containers;
b. the date of receipt;
c. the manufacturer‘s and/ or supplier‘s name;
d. the manufacturer‘s batch or reference number;
e. the total quantity, and number of containers, quantity in each container
received;
f. the control reference number assigned after receipt;
g. any other relevant comment or information.
(c) There shall be written standard operating procedures for the internal labelling,
quarantine and storage of starting materials, packaging materials and other materials,
as appropriate.
(d) 22.1.4 There shall be Standard Operating Procedures available for each instrument
and equipment and these shall be placed in close proximity to the related instrument
and equipment.
(ii) Sampling:
(a) There shall be written Standard Operating Procedures for sampling which include
the person(s) authorized to take the samples.
(b) The sampling instructions shall include:
a. the method of sampling and the sampling plan,
b. the equipment to be used,
c. any precautions to be observed to avoid contamination of the material or any
deterioration in its quality,
d. the quantity of samples to be taken,
e. instructions for any required sub-division or pooling of the samples, (f) the
types of sample container to be used,
f. any specific precautions to be observed, especially in regard to sampling of
sterile and hazardous materials.
(iii) Batch Numbering:

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 Pharmaceutical Jurisprudence V SEM
(a) There shall be Standard Operating Procedures describing the details of the batch
(lot) numbering set up with the objective of ensuring that each batch of intermediate,
bulk or finished product is identified with a specific batch number.
(b) Batch numbering Standard Operating Procedures applied to a processing stage and
to the respective packaging stage shall be same or traceable to demonstrate that they
belong to one homogenous mix.
(c) Batch number allocation shall be immediately recorded in a logbook or by electronic
data processing system. The record shall include date of allocation, product identity
and size of batch.
(iv) Testing:
(a) There shall be written procedures for testing materials and products at different
stages of manufacture, describing the methods and equipment to be used. The tests
performed shall be recorded.
(v) Records of analysis:
(a) The records shall include the following data:
a. name of the material or product and the dosage form,
b. batch number and, where appropriate the manufacturer and/ or supplier,
c. references to the relevant specifications and testing procedures,
d. test results, including observations and calculations, and reference to any
specifications (limits),
e. dates of testing,
f. initials of the persons who performed the testing,
g. initials of the persons who verified the testing and the detailed calculations,
h. a statement of release or rejection, and
i. signature and date of the designated responsible person.
(b) There shall be written standard operating procedures and the associated records of
actions taken for:
a. equipment assembly and validation
b. analytical apparatus and calibration,
c. maintenance, cleaning and sanitation;
d. personnel matters including qualification, training, clothing, hygiene;
e. environmental monitoring;
f. pest control;

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 Pharmaceutical Jurisprudence V SEM
g. complaints;
h. recalls made; and
i. returns received.

Reference Samples

(i) Each lot of every active ingredient, in a quantity sufficient to carry out all the tests,
except sterility and pyrogens/Bacterial Endotoxin Test, shall be retained for a period of
3 months after the date of expiry of the last batch produced from that active ingredient.
(ii) Samples of finished formulations shall be stored in the same or simulated containers in
which the drug has been actually marketed.

Reprocessing and Recoveries

(i) Where reprocessing is necessary, written procedures shall be established and approved
by the Quality Assurance Department that shall specify the conditions and limitations
of repeating chemical reactions. Such reprocessing shall be validt..
(ii) If the product batch has to be reprocessed, the procedure shall be authorized and
recorded. An investigation shall be carried out into the causes necessitating re-
processing and appropriate corrective measures shall be taken for prevention of
recurrence. Re-processed batch shall be subjected to stability evaluation.
(iii) Recovery of the product residue may be carried out, if permitted, in the master
production and control records by incorporating it in subsequent batches of the product.

Distribution records

(a) Prior to distribution or dispatch of given batch of a drug, it shall be ensured that the
batch has been duly tested, approved and released by the quality control personnel. Pre-
dispatch inspection shall be performed on each consignment on a random basis to
ensure that only the correct goods are dispatched. Detailed instructions for warehousing
and stocking of Large Volume Parenterals, if stocked, shall be in existence and shall be
complied with after the batch is released for distribution. Periodic audits of
warehousing practices followed at distribution centers shall be carried out and records
thereof shall be maintained. Standard Operating Procedures shall be developed for
warehousing of products.

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 Pharmaceutical Jurisprudence V SEM
(b) Records for distribution shall be maintained in a manner 1[so as] to facilitate prompt
and complete recall of the batch, if and when necessary.

Validation and process validation

(i) Validation studies shall be an essential part of Good Manufacturing Practices and shall
be conducted as per the pre-defined protocols. These shall include validation of
processing, testing and cleaning procedures.
(ii) A written report summarizing recorded results and conclusions shall be prepared,
documented and maintained.
(iii) Processes and procedures shall be established on the basis of validation study and
undergo periodic revalidation to ensure that they remain capable of achieving the
intended results. Critical processes shall be validt., prospectively or retrospectively.
(iv) When any new Master Formula or method of preparation is adopted, steps shall be
taken to demonstrate its suitability for routine processing. The defined process, using
the materials and equipment specified shall be demonstrated to yield a product
consistently of the required quality.
(v) Significant changes to the manufacturing process, including any change in equipment
or materials that may affect product quality and/or the reproducibility of the process,
shall be validt..

Product Recalls

(i) A prompt and effective product recall system of defective products shall be devised for
timely information of all concerned stockists, wholesalers, suppliers, upto the retail
level within the shortest period. The licensee may make use of both print and electronic
media in this regard.
(ii) There shall be an established written procedure in the form of Standard Operating
Procedure for effective recall of products distributed by the licensee. Recall operations
shall be capable of being initiated promptly so as to effectively reach at the level of
each distribution channel.
(iii) The distribution records shall be readily made available to the persons designated for
recalls.
(iv) The designated person shall record a final report issued, including reconciliation
between the delivered and the recovered quantities of the products.

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 Pharmaceutical Jurisprudence V SEM
(v) The effectiveness of the arrangements for recalls shall be evaluated from time to time.
(vi) The recalled products shall be stored separately in a secured segregated area pending
final decision on them.

Complaints and Adverse Reactions

(i) All complaints thereof concerning product quality shall be carefully reviewed and
recorded according to written procedures. Each complaint shall be
investigated/evaluated by the designated personnel of the company and records of
investigation and remedial action taken thereof shall be maintained.
(ii) Reports of serious adverse drug reactions resulting from the use of a drug along with
comments and documents shall be forthwith reported to the concerned licensing
authority.
(iii) There shall be written procedures describing the action to be taken, recall to be made of
the defective product.

Site Master File

The licensee shall prepare a succinct document in the form of Site Master File containing
specific and factual Good Manufacturing Practices about the production and/or control of
pharmaceutical manufacturing preparations carried out at the licensed premises. It shall
contain the following

(i) General information:

(i) brief information of the firm;
(ii) pharmaceutical manufacturing activities as permitted by the licensing authority;
(iii) other manufacturing activities, if any, carried out on the premises;
(iv) type of products licensed for manufacture with flow charts mentioning procedure
and process flow;
(v) number of employees engaged in the production, quality control, storage and
distribution;
(vi) use of outside scientific, analytical or other technical assistance in relation to
manufacture and analysis;
(vii) short description of the Quality Management System of the firm; and
(viii) products details registered with foreign countries.
(ii) Personnel:

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 Pharmaceutical Jurisprudence V SEM
(a) organisational chart showing the arrangement for quality assurance including
production and quality control;
(b) qualification, experience and responsibilities of key personnel;
(c) outline for arrangements for basic and in-service training and how the records are
maintained;
(d) health requirements for personnel engaged in production; and
(e) personnel hygiene requirements, including clothing.
(iii) Premises:
(a) simple plan or description of manufacturing areas drawn to scale;
(b) nature of construction and fixtures/fittings;
(c) brief description of ventilation systems. More details should be given for critical
areas with potential risk of airborne contamination (schematic drawing of systems).
Classification of the rooms used for the manufacture of sterile products should be
mentioned;
(d) special areas for the handling of the highly toxic, hazardous and sensitizing
materials;
(e) brief description of water system (schematic drawings of systems), including
sanitation;
(f) description of planned preventive maintenance programs for premises and of the
recording system.
(iv) Equipment:
(a) brief description of major equipment used in production and Quality Control
Laboratories (a list of equipment required);
(b) description of planned preventive maintenance programs for equipment and of the
recording system; and
(c) qualification and calibration including the recording systems and arrangements for
computerized systems validation.
(v) Sanitation:
(a) availability of written specifications and procedures for cleaning manufacturing
areas and equipment.
(vi) Documentation. -
(a) arrangements for the preparation, revision and distribution of;
(b) necessary documentation for the manufacture;

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 Pharmaceutical Jurisprudence V SEM
(c) any other documentation related to product quality that is not mentioned elsewhere
(e.g. microbiological controls about air and water).
(vii) Production:
(a) brief description of production operations using, wherever possible, flow sheets and
charts specifying important parameters;
(b) arrangements for the handling of starting materials, packaging materials, bulk and
finished products, including sampling, quarantine, release and storage;
(c) arrangements for the handling of rejected materials and products;
(d) brief description of general policy for process validation.
(viii) Quality Control:
(a) description of the quality control system and of the activities of the Quality Control
Department. Procedures for the release of the finished products.
(ix) Loan licence manufacture and licensee:
(a) description of the way in which compliance of Good Manufacturing Practices by the
loan licensee shall be assessed.
(x) Distribution, complaints and product recall:
(a) arrangements and recording system for distribution;
(b) arrangements for the handling of complaints and product recalls.
(xi) Self inspection
(a) short description of the self-inspection system indicating whether an outside,
independent and experienced external expert was involved in evaluating the
manufacturer‘s compliance with Good manufacturing Practices in all aspects of
production.
(xii) Export of drugs
(a) products exported to different countries;
(b) complaints and product recall, if any.

Schedule N

In the case of a pharmacy a licence in Form 20 or 21 shall not be granted or renewed unless
the licensing authority is satisfied that the requirements prescribed for a pharmacy in
Schedule N have been complied with.

List of Minimum Equipment for the Efficient Running of a Pharmacy

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 Pharmaceutical Jurisprudence V SEM
1. Entrance
a) The front of a pharmacy shall bear an inscription Pharmacy in front.
2. Premises
a) The premises of a pharmacy shall be separated from rooms for private use.
b) The premises shall be well built, dry, well lit and ventilated and, of sufficient
dimensions to allow the goods in stock, especially medicaments and poisons to be
kept in a clearly visible and appropriate manner.
c) The areas of the section to be used as dispensing department shall be not less than 6
square meters for one pharmacist working therein with additional 2 square meters
for each additional pharmacist.
d) The height of the premises shall be at least 2.5 meters.
e) The floor of the pharmacy shall be smooth and washable.
f) The walls shall be plastered or tiled or oil painted so as to maintain smooth, durable
and washable surface devoid of holes, cracks and crevices.
g) A pharmacy shall be provided with ample supply of good quality water.
h) The dispensing department shall be separated by a barrier to prevent the admission
of the public.
3. Furniture and apparatus
a) The furniture and apparatus of a pharmacy shall be adopted to the uses for which
they are intended and correspond to the size and requirements of the establishment.
b) Drugs, chemicals, and medicaments shall be kept in a room appropriate to their
properties and in such special containers as will prevent any deterioration of the
contents or of contents of containers kept near them.
c) Drawers, glasses and other containers used for keeping medicaments shall be of
suitable size and capable of being closed tightly to prevent the entry of dust.
d) Every container shall bear a label of appropriate size, easily readable with names of
medicaments as given in the Pharmacopoeias.
e) A pharmacy shall be provided with a dispensing bench, the top of which shall be
covered with washable and impervious material like stainless steel, laminated or
plastic, etc.
f) A pharmacy shall be provided with a cupboard with lock and key for the storage of
poisons and shall be clearly marked with the work POISON in red letters on a white
background.

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 Pharmaceutical Jurisprudence V SEM
g) Containers of all concentrated solution shall bear special label or marked with the
words ―To be diluted.
h) A Pharmacy shall be provided with the following minimum apparatus and books
necessary for making of official preparations and prescriptions:-

Apparatus
Balance, dispensing, sensitivity 30 mg. Filter paper.
Balance, counter, capacity 3 Kgm., Bottles, prescription, ungraduated assorted
sensitivity 1 gm. sizes.
Beakers, lipped, assorted sizes. Corks assorted sizes and tapers.
Evaporating dishes, porcelain Cork, extracter.
Funnels, glass. Ointment pots with bakelite or suitable caps
Litmas paper, blue and red. Ointment slab, porcelain
Pipette graduated, 2 ml, 5 ml and 10 ml. Ring, stand (retort) iron, complete with rings.
Measure glasses cylindrical 10 ml, 25 ml, Rubber stamps and pad
100 ml and 500 ml.
Mortars and pestles, glass. Scissors
Mortars and pestles, wedgwood. Spatulas, rubber or vulcanite
Tripod stand. Spatulas, stainless steel.
Water bath. Spirit lamp
Weights, Metric, 1 mg. to 100 gm Glass stirring rods.
Pill finisher Thermometer, 0◦C to 200◦C
Pill Machine. Watch glasses
Pill Boxes. Suppository mould.
boxwood. Wire Gauze
Water distillation still in case Eye drops and
Eye lotions are prepared
Books

S.No Books
1 The Indian Pharmacopoeia (Current Edition).
2 National Formulary of Indian (Current Edition).
3 The Drugs and Cosmetics Act, 1940.

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 Pharmaceutical Jurisprudence V SEM
4 The Drugs and Cosmetics Rules, 1945.
5 The Pharmacy Act, 1948.
6 The Dangerous Drugs Act, 1930.

4. General provisions
a) A pharmacy shall be conducted under the continuous personal supervision of a
Registered Pharmacist whose name shall be displayed conspicuously in the
premises.
b) The Pharmacist shall always put on clean white overalls.
c) The premises and fittings of the pharmacy shall be properly kept and everything
shall be in good order and clean.
d) All records and registers shall be maintained in accordance with the laws in force.
e) Any container taken from the poison cupboard shall be replaced therein immediately
after use and the cupboard locked. The keys of the poison cupboard shall be kept in
the personal custody of the responsible person.
f) Medicaments when supplied shall have labels conforming to the provisions of laws
in force.

The above requirements are subject to modifications at the discretion of the licensing
authority, if he is of opinion that having regard to the nature of drugs dispensed, compounded
or prepared by the licensee. It is necessary to relax the above requirements or to impose
additional requirements in the circumstances of a particular case. The decision of the
licensing authority in that regard shall be final.

Schedule U

Provides the details regarding

1. Particulars to be shown in manufacturing records

2. Records of Raw Materials
3. Particulars to be Recorded in the Analytical Records

I. Particulars to be shown in manufacturing records

A. Substances, other than parenteral preparations in general.

1. Serial number

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 Pharmaceutical Jurisprudence V SEM
2. Name of the product
3. Reference of Master Formula Records.
4. Lot/Batch Size.
5. Lot/Batch Number.
6. Date of commencement of manufacture and date of completion of manufacture
and assigned date of expiry.
7. Name of all ingredients, specifications quantities required for the lot/Batch size
and quantities actually used. All weighings and measurements shall be carried out
by a responsible person and initialled by him and shall be counter-checked and
signed by the competent technical staff under whose personal supervision the
ingredients are used for manufacture.
8. Control Numbers of raw materials used in the formulation.
9. Date, time and duration of mixing.
10. Details of environmental controls like room temperature, relative humidity.
11. Date of granulation, wherever applicable.
12. Theoretical weight and actual weight of granules/powder blend.
13. Records of in-processes controls (Periodically whenever necessary):
(a) Uniformity of mixing.
(b) Moisture content of granules/powder in case of Tablet/Capsules.
(c) pH of solution in case of liquid.
(d) Weight variation.
(e) Disintegration time.
(f) Hardness
(g) Friability test
(h) Leak test in case of strip packing.
(i) Filled volume of liquids.
(j) Quantity of tablets/capsules in the final container.
(k) Content of ointment in the filled containers.
14. Date of compression in case of Tablets/date of filling in case of capsules.
15. Date of sealing/coating /polishing in case of capsules/tablets wherever applicable.
16. Reference to analytical Report number stating the result of test and analysis.
17. Separate records of the disposal of the rejected batches and of batches withdrawn
from the market.

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 Pharmaceutical Jurisprudence V SEM
18. The theoretical yield and actual productions yield and packing particulars
indicating the size and quantity of finished packings.
19. Specimen of label/strip, carton with batch coding information like Batch Number,
date of manufacture, date of expiry, retail price as applicable stamped thereon and
inserts used in the finished packings.
20. Signature with date of competent technical staff responsible for the manufacture.
21. Counter-signature of the head of the testing units or other approved person-in-
charge of testing for having verified the batch records and for having released and
batch for sale and distribution, the quantity released and date of release.
22. Date of release of finished packings and quantity released for sale and
distribution.
23. Quantity transferred to warehouse.
24. For Hypodermic tablets and ophthalmic preparations, which are required to be
manufactured under aseptic conditions, records shall be maintained indicating the
precautions taken during the process of manufacture to ensure that aseptic
conditions are maintained.
B. Parenteral Preparations.
1. Serial number.
2. Name of the product.
3. Reference of the master formula record.
4. Batch /Lot size.
5. Batch No. and/or Lot No.
6. Date of commencement of manufacture and date of completion.
7. Names of all ingredients, specifications and quantity required for the Lot/Batch
size and quantity actually used. All weighings and measurements shall be carried
out by a responsible person and initialled by him and shall be countersigned by
the technical staff under whose personal supervision the stock are issued and by
another competent technical staff under whose supervision the ingredients are
used for manufacture.
8. Control numbers of raw materials used in the formulation.
9. Date, time and duration of mixing.
10. Details of environmental controls like temperature, humidity, microbial count in
the sterile working areas.

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 Pharmaceutical Jurisprudence V SEM
11. pH of the solution, wherever applicable
12. Date and method of filtration.
13. Sterility test, reference on bulk batch wherever applicable.
14. Record of check on volume filled.
15. Date of filling.
16. Records of tests employed: -
(a) To ensure that sealed ampoules are leak proof
(b) To check the presence of foreign particles.
(c) Pyrogen test, wherever applicable
(d) Toxicity test, wherever applicable.
17. Records of checking of instruments and apparatus of sterilization (indicators).
18. Records of cleaning and sterilization of containers and closures, if necessary.
19. Records of sterilization in case of parenteral preparations which are heat sterilized
including particulars of time, temperature and pressure employed. Such records
should be marked to relate to the batch sterilized.
20. Number and size of containers filled and quantity rejected.
21. The theoretical yield and actual yield and the percentage yield thereof.
22. Reference to Analytical report numbers stating whether of standard quality or
otherwise.
23. Specimen of labels, cartons, etc. with Batch coding information like batch
number, date of manufacture, date of expiry, as applicable, stamped thereon, and
inserts used in the finished packings.
24. Signature with date of the component technical staff responsible for manufacture.
25. Particulars regarding the precautions taken during the manufacture to ensure that
aseptic conditions are maintained.
26. Countersignature of head of the testing unit or person in charge of testing for
having verified the documents and for having released the product for sale and
distribution, the quantity released and date of release.
27. Records for having transferred to warehouse giving packings and quantities.
28. Separate records of the disposal of the rejected batches and of all batches
withdrawn from the market.
29. Records of reprocessing if any and particulars of reprocessing.

II. Records of Raw Materials

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 Pharmaceutical Jurisprudence V SEM
Records in respect of each raw material shall be maintained indicating the date of receipt,
invoice number, name and address of the manufacturer/supplier, batch number, quantity
received, pack size, date of manufacture, date of expiry, if any, date of analysis and
release/rejection by quality control, analytical report number with special remarks, if any,
quantity issued, date of issue and the particulars of the name and batch numbers of products
for the manufacture of which issued and the proper disposal of the stocks.

III. Particulars to be Recorded in the Analytical Records

A. Tablets and Capsules.

1. Analytical report number.
2. Name of the sample.
3. Date of receipt of sample.
4. Batch/Lot number.
5. Protocols of tests applied.
(a) Description.
(b) Identification.
(c) Uniformity of weight.
(d) Uniformity of diameter (if applicable).
(e) Disintegration test (time in minutes).
(f) Any other tests.
(g) Results of Assay.

Records regarding various tests applied (including readings and calculations) should
be maintained and necessary reference to these records should be entered in Col. 5
above whenever necessary.

6. Signature of the Analyst.

7. Opinion and signature of the approved Analyst.
B. Parenteral Preparations.
1. Analytical report number.
2. Name of the sample.
3. Batch number.
4. Date of receipt of samples.
5. Number of containers filled.

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 Pharmaceutical Jurisprudence V SEM
6. Number of containers received.
7. Protocols of tests applied.
(a) Clarity.
(b) pH wherever applicable.
(c) Identification.
(d) Volume in container.
(e) Sterility
(f) Bulk sample wherever applicable container sample.
(g) Pyrogen test, wherever applicable.
(h) Toxicity test, wherever applicable.
(i) Any other tests.
(j) Results of Assay.

Records regarding various tests applied (including readings and calculations) should
be maintained and necessary reference to these records should be entered in Col. 7
above, wherever necessary.

8. Signature of the Analyst.

9. Opinion and signature of the approved Analyst.

Pyrogen test:

1. Test Report Number.

2. Name of the sample.
3. Batch Number.
4. Number of rabbits used.
5. Weight of each rabbit.
6. Normal temperature of each rabbit.
7. Mean initial temperature of each rabbit.
8. Dose and volume of solution injected into each rabbit and time of injection.
9. Temperature of each rabbit noted at suitable intervals.
10. Maximum temperature.
11. Response.
12. Summed response.
13. Signature of the Analyst.

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 Pharmaceutical Jurisprudence V SEM
14. Opinion and signature of the approved Analyst.

Toxicity Test

1. Test Report Number.

2. Name of the sample.
3. Batch Number.
4. Number of mice used and weight of each mouse.
5. Strength and volume of the drugs injected.
6. Date of injection.
7. Results and remarks.
8. Signature of Analyst.
9. Opinion and signature of the approved Analyst.
C. For Other Drugs
1. Analytical report number.
2. Name of the sample.
3. Batch/Lot number.
4. Date of receipt of sample.
5. Protocol of tests applied.
(a) Description.
(b) Identification.
(c) Any other tests.
(d) Results of Assay.

Particulars regarding various tests applied (including readings and calculations) shall
be maintained and necessary reference to these records shall be entered in Column 5
above, wherever necessary.

6. Signature of Analyst.
7. Opinion and signature of the approved Analyst.
D. Raw Materials
1. Serial number.
2. Name of the materials.
3. Name of the manufacturer/supplier.
4. Quantity received.

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 Pharmaceutical Jurisprudence V SEM
5. Invoice/Challan number and date.
6. Protocols of tests applied.

Particulars regarding various tests applied (including readings and calculations) shall
be maintained and necessary reference to these records shall be entered in Column 6
above, wherever necessary.

E. Container, Packing materials etc.

1. Serial number.
2. Name of the item.
3. Name of the manufacturer/supplier.
4. Quantity received.
5. Invoice/Challan number and date
6. Results of tests applied.

Particulars regarding various tests applied shall be maintained and necessary reference
to these records shall be entered in Column 6 above, wherever necessary

7. Remarks.
8. Signature of the examiner.
(a) The foregoing provisions represent the minimum requirements to be complied with by
the licensee. The Licensing Authority may, however, direct the nature of records to be
maintained by the licensee for such products as are not covered by the categories
described above.
(b) The Licensing Authority may permit the licensee to maintain records in such manner as
are considered satisfactory, provided the basic requirements laid down above are
complied with.
(c) The Licensing Authority may at its discretion direct the licensee to maintain records for
such additional particulars as it may consider necessary in the circumstances of a
particular case.

35 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM

Sale of Drugs

Pharmacy

It means to include every store or shop or other place:

(1) where drugs are dispensed, that is, measured or weighed or made up and supplied ;
or
(2) where prescriptions are compounded; or
(3) where drugs are prepared; or
(4) which has upon it or displayed within it, or affixed to or used in connection with it, a
sign bearing the word or words Pharmacy, Pharmacist, Dispensing Chemist or
Pharmaceutical Chemist; or
(5) which, by sign, symbol or indication within or upon it gives the impression that the
operations mentioned at (1), (2) and (3) are carried out in the premises; or
(6) which is advertised in terms referred to in (4) above. (2) In granting or renewing a
licence under sub-rule (1) the authority empowered to grant it shall have regard

The State Government shall appoint Licensing Authorities for the purpose of this Part for
such areas as may be specified.

Applications for the grant or renewal of a licence

The Applications for the grant or renewal of a licence to sell, stock, exhibit or offer for sale or
distribute drugs are given in following forms are as follows

S.No Form Category of Drugs Fees

1 Form 19 other than those included in Schedule X Rs 1,500/-
2 Form 19A other than those included in Schedule X Rs 500/-
3 Form 19A Itinerant vendor who desires to establish a shop in a Rs 10/-
village or town having population of 5,000 or less.
4 Form 19C drugs included in Schedule X Rs 500/-
5 Form 20 drugs other than those specified in Schedules C, C Rs 1,500/-
(Retail) (1) and X
6 Form 20 A drugs other than those specified in Schedules C, C Rs 1,500/-
(Restricted (1) and X

36 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
Licence)
7 Form 20 B drugs other than those specified in Schedules C, C Rs 1,500/-
(Whole Sale) (1) and X

Duplicate copy of a licence

 A fee of Rs 150/- shall be paid for a duplicate copy of a licence to sell, stock, exhibit
or offer for sale or distribute drugs, other than those included in Schedule X.
 A fee of Rs 150/- shall be paid for a duplicate copy of a licence to sell, stock, exhibit
or offer for sale or distribute drugs, included in Schedule X, if the original is defaced,
damaged or lost.
 In the case of itinerant vendor the fee for a duplicate copy of a licence if the original is
defaced, damaged or lost, shall be Rs 2/-.

Application for renewal of a licence

 Application for renewal of a licence to sell, stock, exhibit or offer for sale or distribute
drugs, after its expiry but within six months of such expiry shall be accompanied by
a fee of Rs 1500/- plus an additional fee at the rate of Rs 500 per month or part
thereof in Form 19.
 Rs 500/- plus an additional fee at the rate of Rs 250/- per month or part thereof in
Form 19-A and Form 19-C
 For itinerant vendor the application for such renewal shall be accompanied by a fee of
Rs 10/-, plus an additional fee at the rate of Rs 8/- per month or part thereof.

Issue of Licence

(1) A licence to sell, stock, exhibit or offer for sale or distribute drugs specified in
Schedule C and C (1) excluding those specified in Schedule X, by are issued in
following forms

S.No Type of Sales Licence Form

1 Retail Form 21
2 Restricted licence Form 21A
3 Wholesale Form 21B

37 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
(2) A licence to sell, stock, exhibit or offer for sale or distribute drugs specified in
Schedule X, by are issued in following forms

S.No Type of Sales Licence Form

1 Retail Form 20F
2 Wholesale Form 20G
(3) If drugs are sold or stocked for sale at more than one place, separate application shall
be made, and a separate licence shall be issued, in respect of each such place.

Restricted licences in Forms 20A and 21A.

(i) Restricted licences in Forms 20A and 21A shall be issued subject to the discretion of
the Licensing Authority, to dealers or persons in respect of drugs whose sale does not
require the supervision of a qualified person.
(ii) Licences to itinerant vendors shall be issued only in exceptional circumstances for
bonafide travelling agents of firms dealing in drugs or for a vendor who purchases
drugs from a licensed dealer for distribution in sparsely populated rural areas where
other channels of distribution of drugs are not available.
(iii) The licensing authority may issue a licence in Form 21A to a travelling agent of a firm
but to no other class of itinerant vendors for the specific purpose of distribution to
medical practitioners or dealers, samples of biological and other special products
specified in Schedule C:

Provided that travelling agents of licensed manufacturers, agents, of such

manufacturers and importers of drugs shall be exempted from taking out licence for the
free distribution of samples of medicines among members of the medical profession,
hospitals, dispensaries and the medical institution or research institutions.

Conditions to be satisfied before a licence in Form 20A or Form 21A is granted

(1) A licence in Form 20A or Form 21A shall not be granted to any person, unless the
authority empowered to grant the licence is satisfied that the premises in respect of
which the licence is to be granted are adequate and equipped with proper storage
accommodation for preserving the properties of drugs to which the licence applies:
Provided that this condition shall not apply in the case of licence granted to itinerant
vendors.

38 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
(2) In granting a licence under Rule 62A the authority empowered to grant it shall have
regard to:
(i) the number of licences granted in the locality during one year immediately
preceding; and
(ii) the occupation, trade or business carried on by such applicant : Provided that the
licensing authority may refuse to grant or renew a licence to any applicant or
licensee in respect of whom it is satisfied that by reason of his conviction of an
offence under the Act or these Rules or the previous cancellation or suspension of
any licence granted thereunder, he is not a fit person to whom a licence should be
granted under this rule.
(3) Any person who is aggrieved by the order passed by the licensing authority in sub-rule
(1) may, within 30 days from the date of the receipt of such order appeal to the State
Government and the State Government may, after such enquiry into the matter as it
considers necessary and after giving the appellant an opportunity for representing his
views in the matter make such order in relation thereto as it thinks fit.

Licence to sell drugs by wholesale or to distribute the same from a motor vehicle

Application for licence to sell drugs by wholesale or to distribute the same from a motor
vehicle

(1) Application for the grant or renewal of a licence to sell by wholesale or to distribute
from a motor vehicle shall be made to the Licensing Authority in Form 19AA and shall
be accompanied by a fee of Rs 500/-:
Provided that if the applicant applies for the renewal of a licence after its expiry but
within six months of such expiry , the fee payable for renewal of such licence shall be
Rs 500/- plus an additional fee at the rate of Rs 250/- per month or part thereof.
(2) A fee of Rs 150/- shall be paid for a duplicate copy of a licence issued under this rule, if
the original is defaced, damaged or lost.

Form of licences to sell drugs by wholesale or distribute drugs from a motor vehicle.

(1) A licence shall be issued for sale by wholesale or for distribution from a motor vehicle
of drugs as follows

S.No Category of Drugs Licence Form

39 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
1 drugs other than those specified in Schedule and Form 20BB
Schedule C(1)
2 drugs specified in Schedule C and Schedule C(1) Form 21BB

Duration of licence

An original licence or a renewed licence to sell drugs, unless sooner suspended or cancelled,
shall be valid for a period of five years on and from the date on which it is granted or
renewed: Provided that if the application for renewal of licence in force is made before its
expiry or if the application is made within six months of its expiry, after payment of
additional fee, the licence shall continue to be in force until orders are passed on the
application. The licence shall be deemed to have expired if application for its renewal is not
made within six months after its expiry.

Certificate of renewal of a sale licence

(1) The certificate of renewal of a sale licence in Forms 20, 20A, 20B,3[20F, 20G], 21,
21A and 21B shall be issued in Form 21C.
(2) A certificate of renewal of a licence in Form 20BB or Form 21BB shall be issued in
Form 21CC.

Conditions to be satisfied before a licence in Form [20, 20B, 20F, 20G, 21 or 21B] is
granted

(2) A licence in Form [20, 20B, 20F, 20G, 21 or 21B] to sell, stock, exhibit or offer for sale
or distribute drugs shall not be granted or renewed to any person unless the authority
empowered to grant the licence is satisfied that the premises in respect of which the
licence is to be granted or renewed are adequate, equipped with proper storage
accommodation for preserving the properties of the drugs to which the licence applies
and are in charge of a person competent in the opinion of the licensing authority to
supervise and control the sale, distribution and preservation of drugs :
Provided that in the case of a pharmacy a licence in Form 20 or 21 shall not be granted
or renewed unless the licensing authority is satisfied that the requirements prescribed
for a pharmacy in Schedule N have been complied with:

40 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
Provided further that licence in Form 20F shall be granted or renewed only to a
pharmacy and in areas where a pharmacy is not operating, such licence may be granted
or renewed to a chemist and druggist.
(3) In granting or renewing a licence under sub-rule (1) the authority empowered to grant it
shall have regard
(i) to the average number of licences granted or renewed during the period of 3 years
immediately preceding, and
(ii) to the occupation, trade or business ordinarily carried on by such applicant during
the period aforesaid:

Provided that the licensing authority may refuse to grant or renew a licence to any
applicant or licensee in respect of whom it is satisfied that by reason of his conviction
of an offence under the Act or these rules, or the previous cancellation or suspension of
any licence granted or renewed thereunder, he is not a fit person to whom a licence
should be granted or renewed under this rule. Every such order shall be communicated
to the licensee as soon as possible:

Provided further that in respect of an application for the grant of a licence in Form 20B
or Form 21B or both, the licensing authority shall satisfy himself that the premises in
respect of which a wholesale licence is to be granted or renewed are:-

(i) of an area of not less than ten square meters; and

(ii) in the charge of a competent person, who
(a) is a Registered Pharmacist, or
(b) has passed the matriculation examination or its equivalent examination
from a recognised Board with four years‘ experience in dealing with sale of
drugs, or
(c) holds a degree of a recognised University with one year‘s experience in
dealing with drugs:

Provided also that,-

(i) in respect of an application for the grant of a licence in Form 20 or Form 21 or

both, the licensing authority shall satisfy itself that the premises are of an area of
not less than 10 square meters, and
(ii) in respect of an application for the grant of a licence

41 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
(A) In Form 20 or Form 21 or both, and
(B) In Form 20 B or Form 21B or both,

the licensing authority shall satisfy itself that the premises are of an area not less than
15 square meters: Provided also that the provisions of the preceding proviso shall not
apply to the premises for which licences have been issued by the licensing authority
before the commencement of the Drugs and Cosmetics (1st Amendment) Rules, 1997.

(3) Any person who is aggrieved by the order passed by the licensing authority in sub-Rule
(1) may, within 30 days from the date of receipt of such order, appeal to the State
Government and the State Government may, after such enquiry into the matter as it
considers necessary and after giving the appellant an opportunity for representing his
views in the matter, make such an order in relation thereto as it thinks fit.

Condition of licences in Forms 20, 20-A, 20-B, 20-F, 20-G, 21 and 21-B

Licences in Forms 20, 20-A, 20-B, 20-F, 20-G, 21 and 21-B shall be subject to the conditions
stated therein and to the following general conditions

(1) Any drug shall, if compounded or made on the licensee‘s premises be compounded or
made by or under the direct and personal supervision of a registered Pharmacist.
(2) The supply, otherwise than by way of wholesale dealing, of any drug supplied on the
prescription of a Registered Medical Practitioner shall be effected only by or under the
personal supervision of a registered Pharmacist.\
(3) (1) The supply of any drug other than those specified in Schedule X on a prescription of
a Registered Medical Practitioner shall be recorded at the time of supply in a
prescription register specially maintained for the purpose and the serial number of the
entry in the register shall be entered on the prescription. The following particulars shall
be entered in the register:
(i) serial number of the entry,
(ii) the date of supply,
(iii) the name and address of the prescriber,
(iv) the name and address of the patient, or the name and address of the owner
of the animal if the drug supplied is for veterinary use,
(v) the name of the drug or preparation and the quantity or in the case of a
medicine made up by the licensee, the ingredients and quantities thereof,

42 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
(vi) in the case of a drug specified in Schedule C or Schedule H and Schedule
H1 the name of the manufacturer of the drug, its batch number and the date
of expiry of potency, if any,
(vii) the signature of the registered Pharmacist by or under whose supervision
the medicine was made up or supplied: Provided that in the case of drugs
which are not compounded in the premises and which are supplied from or
in the original containers, the particulars specified in items (a) to (g) above
may be entered in a cash or credit memo book, serially numbered and
specially maintained for this purpose:

Provided further that if the medicine is supplied on a prescription on which the

medicine has been supplied on a previous occasion and entries made in the
prescription register, it shall be sufficient if the new entry in the register includes a
serial number, the date of supply, the quantity supplied and a sufficient reference to an
entry in the register recording the dispensing of the medicine on the previous
occasion:

Provided also that it shall not be necessary to record the above details in the register
or in the cash or credit memo particulars in respect of−

(i) any drugs supplied against prescription under the Employees State Insurance
Scheme if all the above particulars are given in that prescription, and
(ii) any drug other than that specified in Schedule C or Schedule H and Schedule H1
if it is supplied in the original unopened container of the manufacturer and if the
prescription is duly stamped at the time of supply with the name of the supplier
and the date on which the supply was made and on condition that the provisions
of sub-rule (4)(3) of this rule are complied with.
(iii) the supply of a drug specified in Schedule H1 shall be recorded in a separate
register at the time of the supply giving the name and address of the prescriber,
the name of the patient, the name of the drug and the quantity supplied and such
records shall be maintained for three years and be open for inspection.
(2) The option to maintain a prescription register or a cash or credit memo book in
respect of drugs and medicines which are supplied from or in the original
container, shall be made in writing to the Licensing Authority at the time of
application for the grant or renewal of the licence to sell by retail:

43 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
Provided that the Licensing Authority may require records to be maintained only in
prescription register if it is satisfied that the entries in the carbon copy of the cash or
credit memo book are not legible.

(4) (1) The supply by retail, otherwise than on a prescription of a drug specified in
Schedule C shall be recorded at the time of supply either−
(i) in a register specially maintained for the purpose in which the following
particulars shall be entered :
(a) serial number of the entry,
(b) the date of supply,
(c) the name and address of the purchaser,
(d) the name of the drug and the quantity thereof,
(e) in the case of a drug specified in Schedule C, the name of the manufacturer,
the batch number and the date of expiry of potency,
(f) the signature of the person under whose supervision the sale was effected,
or
(ii) in a cash or credit memo book, serially numbered containing all the particulars
specified in items (b) to (f) of sub-clause (i) above.

The entries in the carbon copy of the cash or credit memo which is retained by the licensee
shall be maintained in a legible manner.

(2) The option to maintain a register or a cash or credit memo book shall be made in
writing to the Licensing Authority at the time of application for the grant or renewal of
a licence to sell by retail:

Provided that the Licensing Authority may require records to be maintained in a

register if it is satisfied that the entries in the carbon copy of the cash/credit memo book
are not legible.

(3) (i) The supply by retail of any drug shall be made against a cash/credit memo which
shall contain the following particulars :
(1) Name, address and sale licence number of the dealer,
(2) Serial number of the cash/credit memo,
(3) the name and quantity of the drug supplied.

44 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
(ii) Carbon copies of cash/credit memos shall be maintained by the licensee as
record.
(4) (i) Records of purchase of a drug intended for sale or sold by retail shall be maintained
by the licensee and such records shall show the following particulars, namely:
(a) the date of purchase,
(b) the name and address of the person from whom purchased and the number of the
relevant licence held by him,
(c) the name of the drug, the quantity and the batch number, and
(d) the name of the manufacturer of the drug.
(ii) Purchase bills including cash or credit memo shall be serially numbered by the
licensee and maintained by him in a chronological order.
(5) (1) Subject to the other provisions of these Rules the supply of a drug by wholesale
shall be made against a cash or credit memo bearing the name and address of the
licensee and his licence number under the Drugs and Cosmetics Act in which the
following particulars shall be entered
(a) the date of sale,
(b) the name, address of the licensee to whom sold and his sale licence number. In
case of sale to an authority purchasing on behalf of Government, or to a hospital,
medical, educational or research institution or to a Registered Medical
Practitioner for the purpose of supply to his patients the name and address of the
authority, institution or the Registered Medical Practitioner as the case may be,
(c) the name of the drug, the quantity and the batch number,
(d) the name of the manufacturer,
(e) the signature of the competent person under whose supervision the sale was
effected.
(2) Carbon copies of cash or credit memos specified in clause (1) shall be preserved as
records for a period of three years from the date of the sale of the drug.
(3) (i) Records of purchase of a drug intended for resale or sold by wholesale shall be
maintained by the licensee and such records shall show the following particulars,
namely:-
(a) the date of purchase,
(b) the name, address and the number of the relevant licence held by the person
from whom purchased,

45 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
(c) the name of the drug, the quantity and the batch number, and
(d) the name of the manufacturer of the drug.
(ii) Purchase bills including cash or credit memos shall be serially numbered by
the licensee and maintained by him in a chronological order.]
(6) The licensee shall produce for inspection by an Inspector appointed under the Act on
demand all registers and records maintained under these Rules, and shall supply to the
Inspector such information as he may require for the purpose of ascertaining whether
the provisions of the Act and Rules thereunder have been observed.
(7) Except where otherwise provided in these Rules, all registers and records maintained
under these Rules shall be preserved for a period of not less than two years from the
date of the last entry therein.
(8) Notwithstanding anything contained in this Rule it shall not be necessary to record
particulars in a register specially maintained for the purpose if the particulars are
recorded in any other register specially maintained under any other law for the time
being in force.
(9) (a) Substances specified in Schedule H and Schedule H1 or Schedule X shall not be
sold by retail except on and in accordance with the prescription of a Registered Medical
Practitioner and in the case of substances specified in Schedule X, the prescriptions
shall be in duplicate, one copy of which shall be retained by the licensee for a period of
two years.
(b) The supply of drugs specified in Schedule H and Schedule H1 or Schedule X to
Registered Medical Practitioners, Hospitals, Dispensaries and Nursing Homes shall be
made only against the signed order in writing which shall be preserved by the licensee
for a period of two years.
(10) For the purposes of clause (9) a prescription shall
(a) be in writing an be signed by the person giving it with his usual signature and be
dated by him;
(b) specify the name and address of the person for whose treatment it is given, or the
name and address of the owner of the animal if the drug is meant for veterinary
use;
(c) indicate the total amount of the medicine to be supplied and the dose to be taken.

46 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
(11) The person dispensing a prescription containing a drug specified in Schedule H and
Schedule H1 and Schedule X shall comply with the following requirements in addition
to other requirement of these rules.
(a) the prescription must not be dispensed more than once unless the prescriber has
stated thereon that it may be dispensed more than once;
(b) if the prescription contains a direction that it may be dispensed a stated number of
times or at stated intervals it must not be dispensed otherwise than in accordance
with the directions;
(c) at the time of dispensing there must be noted on the prescription above the
signature of the prescriber the name and address of the seller and the date on
which the prescription is dispensed.

(11-A) No person dispensing a prescription containing substances specified in Schedule H

and Schedule H1 or X, may supply any other preparation, whether containing the same
substance or not, in lieu thereof.

(12) Substances specified in Schedule X kept in retail shop or premises used in connection
therewith shall be stored—
(a) under lock and key in cupboard or drawer reserved solely for the storage of these
substances; or
(b) in a part of the premises separated from the remainder of the premises and to
which only responsible persons have access;
(1) (a) The description ―Drugstore‖ shall be displayed by such licensees who do not
require the services of a Registered Pharmacist.
(b) The description ―Chemists and Druggists‖ shall be displayed by such licensees
who employ the services of a Registered Pharmacist but who do not maintain a
Pharmacy for compounding against prescriptions.
(c) The description Pharmacy, Pharmacist, Dispensing Chemist or Pharmaceutical
Chemist shall be displayed by such licensees who employ the services of a
Registered Pharmacist and maintain a Pharmacy for compounding against
prescriptions:
(2) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to
record his impressions and the defects noticed.

47 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
(3) No drug shall be sold or stocked by the licensee after the date of expiration of potency
recorded on its container, label or wrapper, or in violation of any statement or direction
recorded on such container, label or wrapper:

Provided that any such drugs in respect of which the licensee has taken steps with the
manufacturer or his representative for the withdrawal, reimbursement or disposal of the
same, may be stocked after the date of expiration of potency pending such withdrawal,
reimbursement or disposal, as the case may be, subject to the condition that the same
shall be stored separately from the trade stocks and all such drugs shall be kept in
packages or cartons, the top of which shall display prominently, the words Not for sale.

(4) No drug intended for distribution to the medical profession as free sample which bears
a label on the container as specified in clause 4[(ix)] of sub-rule (1) of rule 96, and no
drug meant for consumption by the Employees‘ State Insurance Corporation, the
Central Government Health Scheme, the Government Medical Stores Depots, the
Armed Forces Medical Stores or other Government institutions, which bears a
distinguishing mark or any inscription on the drug or on the label affixed to the
container thereof indicating this purpose shall be sold or stocked by the licensee on his
premises:

Provided that this sub-rule shall not be applicable to licensees who have been appointed
as approved chemists, by the State Government in writing, under the employees‘ State
Insurance Scheme, or have been appointed as authorised agent or distributor, by the
manufacturer in writing, for drugs meant for consumption under the Central
Government Health Scheme, the Government Medical Stores Depots, the Armed
Forces Medical Stores or other Government Institutions for drugs meant for
consumption under those schemes or have been appointed as authorised Depots or
Carrying and Forwarding agent by the manufacturer in writing, for storing free samples
meant for distribution to medical profession subject to the conditions that the stock
shall be stored separately from the trade stocks and shall maintain separate records of
the stocks received and distributed by them.

(5) The supply by retail of any drug in a container other than the one in which the
manufacturer has marketed the drug, shall be made only by dealers who employ the
services of a Registered Pharmacist and such supply shall be made under the direct

48 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
supervision of the Registered Pharmacist] in an envelope or other suitable wrapper or
container showing the following particulars on the label:
(a) name of the drug,
(b) the quantity supplied,
(c) the name and address of the dealer.]
(6) The medicines for treatment of animals kept in a retail shop or premises shall be
labelled with the words Not for human use and shall be stored for treatment of
animals only.
(a) in a cupboard or drawer reserved solely for the storage of veterinary drugs, or
(b) in a part of the premises separated from the remainder of the premises to which
customers are not permitted to have access.]
(7) (a) The supply of drugs specified in Schedule X shall be recorded at the time of supply
in a register (bound and serially page numbered) specially maintained for the purpose
and separate pages shall be allotted for each drug.
(b) The following particulars shall be entered in the said register, namely:--
(i) Date of transaction;
(ii) Quantity received, if any, the name and address of the supplier and the
number of the relevant licence held by the supplier;
(iii) Name of the drug;
(iv) Quantity supplied;
(v) Manufacturer‘s name;
(vi) Batch No. or Lot No;
(vii) Name and address of the patient/purchaser;
(viii) Reference Number of the prescription against which supplies were made;
(ix) Bill No and date in respect of purchases and supplies made by him;
(x) Signature of the person under whose supervision the drugs have been
supplied.

Wholesale sale

Applications for the grant or renewal of a licence

The Applications for the grant or renewal of a licence to sell, stock, exhibit or offer for sale or
distribute drugs are given in following forms are as follows

49 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
S.No Form Category of Drugs Fees
1 Form 20 B drugs other than those specified in Schedules C, C Rs 1,500/-
(Whole Sale) (1) and X

Duplicate copy of a licence

 A fee of Rs 150/- shall be paid for a duplicate copy of a licence to sell, stock, exhibit
or offer for sale or distribute drugs, other than those included in Schedule X.
 A fee of Rs 150/- shall be paid for a duplicate copy of a licence to sell, stock, exhibit
or offer for sale or distribute drugs, included in Schedule X, if the original is defaced,
damaged or lost.

Application for renewal of a licence

 Application for renewal of a licence to sell, stock, exhibit or offer for sale or distribute
drugs, after its expiry but within six months of such expiry shall be accompanied by
a fee of Rs 1500/- plus an additional fee at the rate of Rs 500 per month or part
thereof in Form 20 B.

Issue of Licence

(1) A licence to sell, stock, exhibit or offer for sale or distribute drugs specified in
Schedule C and C (1) excluding those specified in Schedule X, by are issued in
following forms

S.No Type of Sales Licence Form

1 Wholesale Form 21B

(2) A licence to sell, stock, exhibit or offer for sale or distribute drugs specified in
Schedule X, by are issued in following forms

S.No Type of Sales Licence Form

1 Wholesale Form 20G
(3) If drugs are sold or stocked for sale at more than one place, separate application shall
be made, and a separate licence shall be issued, in respect of each such place.

Licence to sell drugs by wholesale or to distribute the same from a motor vehicle

50 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
Application for licence to sell drugs by wholesale or to distribute the same from a motor
vehicle

(1) Application for the grant or renewal of a licence to sell by wholesale or to distribute
from a motor vehicle shall be made to the Licensing Authority in Form 19AA and shall
be accompanied by a fee of Rs 500/-:
Provided that if the applicant applies for the renewal of a licence after its expiry but
within six months of such expiry , the fee payable for renewal of such licence shall be
Rs 500/- plus an additional fee at the rate of Rs 250/- per month or part thereof.
(2) A fee of Rs 150/- shall be paid for a duplicate copy of a licence issued under this rule, if
the original is defaced, damaged or lost.

Form of licences to sell drugs by wholesale or distribute drugs from a motor vehicle.

(1) A licence shall be issued for sale by wholesale or for distribution from a motor vehicle
of drugs as follows

S.No Category of Drugs Licence Form

1 drugs other than those specified in Schedule and Form 20BB
Schedule C(1)
2 drugs specified in Schedule C and Schedule C(1) Form 21BB

Duration of licence

An original licence or a renewed licence to sell drugs, unless sooner suspended or cancelled,
shall be valid for a period of five years on and from the date on which it is granted or
renewed: Provided that if the application for renewal of licence in force is made before its
expiry or if the application is made within six months of its expiry, after payment of
additional fee, the licence shall continue to be in force until orders are passed on the
application. The licence shall be deemed to have expired if application for its renewal is not
made within six months after its expiry.

Certificate of renewal of a sale licence

(1) The certificate of renewal of a sale licence in Forms 20B shall be issued in Form 21C.
(2) A certificate of renewal of a licence in Form 20BB or Form 21BB shall be issued in
Form 21CC.

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 Pharmaceutical Jurisprudence V SEM
Conditions to be satisfied before a licence in Form 20B, 20G is granted

(1) A licence in Form 20B, 20G to sell, stock, exhibit or offer for sale or distribute drugs
shall not be granted or renewed to any person unless the authority empowered to grant
the licence is satisfied that the premises in respect of which the licence is to be granted
or renewed are adequate, equipped with proper storage accommodation for preserving
the properties of the drugs to which the licence applies and are in charge of a person
competent in the opinion of the licensing authority to supervise and control the sale,
distribution and preservation of drugs :
Provided that in the case of a pharmacy a licence in Form 20 or 21 shall not be granted
or renewed unless the licensing authority is satisfied that the requirements prescribed
for a pharmacy in Schedule N have been complied with:
Provided further that licence in Form 20F shall be granted or renewed only to a
pharmacy and in areas where a pharmacy is not operating, such licence may be granted
or renewed to a chemist and druggist.
(2) In granting or renewing a licence under sub-rule (1) the authority empowered to grant it
shall have regard
(i) to the average number of licences granted or renewed during the period of 3 years
immediately preceding, and
(ii) to the occupation, trade or business ordinarily carried on by such applicant during
the period aforesaid:

Provided that the licensing authority may refuse to grant or renew a licence to any
applicant or licensee in respect of whom it is satisfied that by reason of his conviction
of an offence under the Act or these rules, or the previous cancellation or suspension of
any licence granted or renewed thereunder, he is not a fit person to whom a licence
should be granted or renewed under this rule. Every such order shall be communicated
to the licensee as soon as possible:

Provided further that in respect of an application for the grant of a licence in Form 20B
or Form 21B or both, the licensing authority shall satisfy himself that the premises in
respect of which a wholesale licence is to be granted or renewed are:-

a. of an area of not less than ten square meters; and

b. in the charge of a competent person, who

52 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
i. is a Registered Pharmacist, or
ii. has passed the matriculation examination or its equivalent examination
from a recognised Board with four years‘ experience in dealing with sale of
drugs, or
iii. holds a degree of a recognised University with one year‘s experience in
dealing with drugs:

Provided also that,-

(iii) in respect of an application for the grant of a licence in Form 20 or Form 21 or

both, the licensing authority shall satisfy itself that the premises are of an area of
not less than 10 square meters, and
(iv) in respect of an application for the grant of a licence
(C) In Form 20 or Form 21 or both, and
(D) In Form 20 B or Form 21B or both,

the licensing authority shall satisfy itself that the premises are of an area not less than
15 square meters: Provided also that the provisions of the preceding proviso shall not
apply to the premises for which licences have been issued by the licensing authority
before the commencement of the Drugs and Cosmetics (1st Amendment) Rules, 1997.

(4) Any person who is aggrieved by the order passed by the licensing authority in sub-Rule
(1) may, within 30 days from the date of receipt of such order, appeal to the State
Government and the State Government may, after such enquiry into the matter as it
considers necessary and after giving the appellant an opportunity for representing his
views in the matter, make such an order in relation thereto as it thinks fit.

Condition of licences in Forms 20, 20-A, 20-B, 20-F, 20-G, 21 and 21-B

Licences in Forms 20, 20-A, 20-B, 20-F, 20-G, 21 and 21-B shall be subject to the conditions
stated therein and to the following general conditions

(1) Any drug shall, if compounded or made on the licensee‘s premises be compounded or
made by or under the direct and personal supervision of a registered Pharmacist.
(2) The supply, otherwise than by way of wholesale dealing, of any drug supplied on the
prescription of a Registered Medical Practitioner shall be effected only by or under the
personal supervision of a registered Pharmacist.\

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 Pharmaceutical Jurisprudence V SEM
(3) (1) The supply of any drug other than those specified in Schedule X on a prescription of
a Registered Medical Practitioner shall be recorded at the time of supply in a
prescription register specially maintained for the purpose and the serial number of the
entry in the register shall be entered on the prescription. The following particulars shall
be entered in the register:
(i) serial number of the entry,
(ii) the date of supply,
(iii) the name and address of the prescriber,
(iv) the name and address of the patient, or the name and address of the owner
of the animal if the drug supplied is for veterinary use,
(v) the name of the drug or preparation and the quantity or in the case of a
medicine made up by the licensee, the ingredients and quantities thereof,
(vi) in the case of a drug specified in Schedule C or Schedule H and Schedule
H1 the name of the manufacturer of the drug, its batch number and the date
of expiry of potency, if any,
(vii) the signature of the registered Pharmacist by or under whose supervision
the medicine was made up or supplied: Provided that in the case of drugs
which are not compounded in the premises and which are supplied from or
in the original containers, the particulars specified in items (a) to (g) above
may be entered in a cash or credit memo book, serially numbered and
specially maintained for this purpose:

Provided further that if the medicine is supplied on a prescription on which the

medicine has been supplied on a previous occasion and entries made in the
prescription register, it shall be sufficient if the new entry in the register includes a
serial number, the date of supply, the quantity supplied and a sufficient reference to an
entry in the register recording the dispensing of the medicine on the previous
occasion:

Provided also that it shall not be necessary to record the above details in the register
or in the cash or credit memo particulars in respect of−

(i) any drugs supplied against prescription under the Employees State Insurance
Scheme if all the above particulars are given in that prescription, and

54 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
(ii) any drug other than that specified in Schedule C or Schedule H and Schedule H1
if it is supplied in the original unopened container of the manufacturer and if the
prescription is duly stamped at the time of supply with the name of the supplier
and the date on which the supply was made and on condition that the provisions
of sub-rule (4)(3) of this rule are complied with.
(iii) the supply of a drug specified in Schedule H1 shall be recorded in a separate
register at the time of the supply giving the name and address of the prescriber,
the name of the patient, the name of the drug and the quantity supplied and such
records shall be maintained for three years and be open for inspection.
(3) The option to maintain a prescription register or a cash or credit memo book in
respect of drugs and medicines which are supplied from or in the original
container, shall be made in writing to the Licensing Authority at the time of
application for the grant or renewal of the licence to sell by retail:

Provided that the Licensing Authority may require records to be maintained only in
prescription register if it is satisfied that the entries in the carbon copy of the cash or
credit memo book are not legible.

(5) (1) The supply by retail, otherwise than on a prescription of a drug specified in
Schedule C shall be recorded at the time of supply either−
(iii) in a register specially maintained for the purpose in which the following
particulars shall be entered :
(a) serial number of the entry,
(b) the date of supply,
(c) the name and address of the purchaser,
(d) the name of the drug and the quantity thereof,
(e) in the case of a drug specified in Schedule C, the name of the manufacturer,
the batch number and the date of expiry of potency,
(f) the signature of the person under whose supervision the sale was effected,
or
(iv) in a cash or credit memo book, serially numbered containing all the particulars
specified in items (b) to (f) of sub-clause (i) above.

The entries in the carbon copy of the cash or credit memo which is retained by the licensee
shall be maintained in a legible manner.

55 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
(2) The option to maintain a register or a cash or credit memo book shall be made in
writing to the Licensing Authority at the time of application for the grant or
renewal of a licence to sell by retail:

Provided that the Licensing Authority may require records to be maintained in a

register if it is satisfied that the entries in the carbon copy of the cash/credit memo book
are not legible.

(3) (i) The supply by retail of any drug shall be made against a cash/credit memo
which shall contain the following particulars :
(4) Name, address and sale licence number of the dealer,
(5) Serial number of the cash/credit memo,
(6) the name and quantity of the drug supplied.
(iii) Carbon copies of cash/credit memos shall be maintained by the licensee as
record.
(6) (i) Records of purchase of a drug intended for sale or sold by retail shall be maintained
by the licensee and such records shall show the following particulars, namely:
(1) the date of purchase,
(2) the name and address of the person from whom purchased and the number of the
relevant licence held by him,
(3) the name of the drug, the quantity and the batch number, and
(4) the name of the manufacturer of the drug.
(iii) Purchase bills including cash or credit memo shall be serially numbered by the
licensee and maintained by him in a chronological order.
(7) (1) Subject to the other provisions of these Rules the supply of a drug by wholesale
shall be made against a cash or credit memo bearing the name and address of the
licensee and his licence number under the Drugs and Cosmetics Act in which the
following particulars shall be entered
(a) the date of sale,
(b) the name, address of the licensee to whom sold and his sale licence number. In
case of sale to an authority purchasing on behalf of Government, or to a hospital,
medical, educational or research institution or to a Registered Medical
Practitioner for the purpose of supply to his patients the name and address of the
authority, institution or the Registered Medical Practitioner as the case may be,

56 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
(c) the name of the drug, the quantity and the batch number,
(d) the name of the manufacturer,
(e) the signature of the competent person under whose supervision the sale was
effected.
(2) Carbon copies of cash or credit memos specified in clause (1) shall be preserved as
records for a period of three years from the date of the sale of the drug.
(3) (i) Records of purchase of a drug intended for resale or sold by wholesale shall be
maintained by the licensee and such records shall show the following particulars,
namely:-
(1) the date of purchase,
(2) the name, address and the number of the relevant licence held by the person
from whom purchased,
(3) the name of the drug, the quantity and the batch number, and
(4) the name of the manufacturer of the drug.
(iii) Purchase bills including cash or credit memos shall be serially numbered by
the licensee and maintained by him in a chronological order.]
(8) The licensee shall produce for inspection by an Inspector appointed under the Act on
demand all registers and records maintained under these Rules, and shall supply to the
Inspector such information as he may require for the purpose of ascertaining whether
the provisions of the Act and Rules thereunder have been observed.
(9) Except where otherwise provided in these Rules, all registers and records maintained
under these Rules shall be preserved for a period of not less than two years from the
date of the last entry therein.
(10) Notwithstanding anything contained in this Rule it shall not be necessary to record
particulars in a register specially maintained for the purpose if the particulars are
recorded in any other register specially maintained under any other law for the time
being in force.
(11) (a) Substances specified in Schedule H and Schedule H1 or Schedule X shall not be
sold by retail except on and in accordance with the prescription of a Registered Medical
Practitioner and in the case of substances specified in Schedule X, the prescriptions
shall be in duplicate, one copy of which shall be retained by the licensee for a period of
two years.

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 Pharmaceutical Jurisprudence V SEM
(b) The supply of drugs specified in Schedule H and Schedule H1 or Schedule X to
Registered Medical Practitioners, Hospitals, Dispensaries and Nursing Homes shall be
made only against the signed order in writing which shall be preserved by the licensee
for a period of two years.
(12) For the purposes of clause (9) a prescription shall
(i) be in writing an be signed by the person giving it with his usual signature and be
dated by him;
(ii) specify the name and address of the person for whose treatment it is given, or the
name and address of the owner of the animal if the drug is meant for veterinary
use;
(iii) indicate the total amount of the medicine to be supplied and the dose to be taken.
(13) The person dispensing a prescription containing a drug specified in Schedule H and
Schedule H1 and Schedule X shall comply with the following requirements in addition
to other requirement of these rules.
a. the prescription must not be dispensed more than once unless the prescriber has
stated thereon that it may be dispensed more than once;
b. if the prescription contains a direction that it may be dispensed a stated number of
times or at stated intervals it must not be dispensed otherwise than in accordance
with the directions;
c. at the time of dispensing there must be noted on the prescription above the
signature of the prescriber the name and address of the seller and the date on
which the prescription is dispensed.

(11-A) No person dispensing a prescription containing substances specified in Schedule H

and Schedule H1 or X, may supply any other preparation, whether containing the same
substance or not, in lieu thereof.

(14) Substances specified in Schedule X kept in retail shop or premises used in connection
therewith shall be stored—
a. under lock and key in cupboard or drawer reserved solely for the storage of these
substances; or
b. in a part of the premises separated from the remainder of the premises and to
which only responsible persons have access;

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 Pharmaceutical Jurisprudence V SEM
(8) (a) The description ―Drugstore‖ shall be displayed by such licensees who do not
require the services of a Registered Pharmacist.
(i) The description ―Chemists and Druggists‖ shall be displayed by such licensees
who employ the services of a Registered Pharmacist but who do not maintain a
Pharmacy for compounding against prescriptions.
(ii) The description Pharmacy, Pharmacist, Dispensing Chemist or Pharmaceutical
Chemist shall be displayed by such licensees who employ the services of a
Registered Pharmacist and maintain a Pharmacy for compounding against
prescriptions:
(9) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to
record his impressions and the defects noticed.
(10) No drug shall be sold or stocked by the licensee after the date of expiration of potency
recorded on its container, label or wrapper, or in violation of any statement or direction
recorded on such container, label or wrapper:

Provided that any such drugs in respect of which the licensee has taken steps with the
manufacturer or his representative for the withdrawal, reimbursement or disposal of the
same, may be stocked after the date of expiration of potency pending such withdrawal,
reimbursement or disposal, as the case may be, subject to the condition that the same
shall be stored separately from the trade stocks and all such drugs shall be kept in
packages or cartons, the top of which shall display prominently, the words Not for sale.

(11) No drug intended for distribution to the medical profession as free sample which bears
a label on the container as specified in clause 4[(ix)] of sub-rule (1) of rule 96, and no
drug meant for consumption by the Employees‘ State Insurance Corporation, the
Central Government Health Scheme, the Government Medical Stores Depots, the
Armed Forces Medical Stores or other Government institutions, which bears a
distinguishing mark or any inscription on the drug or on the label affixed to the
container thereof indicating this purpose shall be sold or stocked by the licensee on his
premises:

Provided that this sub-rule shall not be applicable to licensees who have been appointed
as approved chemists, by the State Government in writing, under the employees‘ State
Insurance Scheme, or have been appointed as authorised agent or distributor, by the
manufacturer in writing, for drugs meant for consumption under the Central

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 Pharmaceutical Jurisprudence V SEM
Government Health Scheme, the Government Medical Stores Depots, the Armed
Forces Medical Stores or other Government Institutions for drugs meant for
consumption under those schemes or have been appointed as authorised Depots or
Carrying and Forwarding agent by the manufacturer in writing, for storing free samples
meant for distribution to medical profession subject to the conditions that the stock
shall be stored separately from the trade stocks and shall maintain separate records of
the stocks received and distributed by them.

(12) The supply by retail of any drug in a container other than the one in which the
manufacturer has marketed the drug, shall be made only by dealers who employ the
services of a Registered Pharmacist and such supply shall be made under the direct
supervision of the Registered Pharmacist] in an envelope or other suitable wrapper or
container showing the following particulars on the label:
(i) name of the drug,
(ii) the quantity supplied,
(iii) the name and address of the dealer.]
(13) The medicines for treatment of animals kept in a retail shop or premises shall be
labelled with the words Not for human use and shall be stored for treatment of
animals only.
(a) in a cupboard or drawer reserved solely for the storage of veterinary drugs, or
(b) in a part of the premises separated from the remainder of the premises to which
customers are not permitted to have access.]
(14) (a) The supply of drugs specified in Schedule X shall be recorded at the time of supply
in a register (bound and serially page numbered) specially maintained for the purpose
and separate pages shall be allotted for each drug.
(c) The following particulars shall be entered in the said register, namely:--
(i) Date of transaction;
(ii) Quantity received, if any, the name and address of the supplier and the
number of the relevant licence held by the supplier;
(iii) Name of the drug;
(iv) Quantity supplied;
(v) Manufacturer‘s name;
(vi) Batch No. or Lot No;
(vii) Name and address of the patient/purchaser;

60 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
(viii) Reference Number of the prescription against which supplies were made;
(ix) Bill No and date in respect of purchases and supplies made by him;
(x) Signature of the person under whose supervision the drugs have been
supplied.

Procedure for disposal of drugs in the event of cancellation of licence

(1) In case a licensee, whose licence has been cancelled, desires to dispose of the drugs he
has in his possession in the premises in respect of which the licence has been cancelled,
he shall apply in writing to the licensing authority for this purpose, giving the following
particulars, namely:
(a) the name and address of the person to whom the drugs are proposed to be sold or
supplied together with the number of the licence for sale or manufacture, as the
case may be, held by him,
(b) the names of drugs together with their quantities, batch numbers, the names and
addresses of their manufacturers and the dates of their expiry, if any, proposed to
be sold to the person mentioned in clause (a).
(2) The licensing authority may, after examination of the particulars referred to in sub-rule
(1) and, if necessary, after inspection by an Inspector of the premises where the drugs
are stocked, grant the necessary permission for their disposal.

Retail sale

Applications for the grant or renewal of a licence

The Applications for the grant or renewal of a licence to sell, stock, exhibit or offer for sale or
distribute drugs are given in following forms are as follows

S.No Form Category of Drugs Fees

1 Form 19 other than those included in Schedule X Rs 1,500/-
2 Form 19A other than those included in Schedule X Rs 500/-
3 Form 19A Itinerant vendor who desires to establish a shop in a Rs 10/-
village or town having population of 5,000 or less.
4 Form 19C drugs included in Schedule X Rs 500/-
5 Form 20 drugs other than those specified in Schedules C, C Rs 1,500/-
(Retail) (1) and X

61 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
6 Form 20 A drugs other than those specified in Schedules C, C Rs 1,500/-
(Restricted (1) and X
Licence)
7 Form 20 B drugs other than those specified in Schedules C, C Rs 1,500/-
(Whole Sale) (1) and X

Duplicate copy of a licence

 A fee of Rs 150/- shall be paid for a duplicate copy of a licence to sell, stock, exhibit
or offer for sale or distribute drugs, other than those included in Schedule X.
 A fee of Rs 150/- shall be paid for a duplicate copy of a licence to sell, stock, exhibit
or offer for sale or distribute drugs, included in Schedule X, if the original is defaced,
damaged or lost.
 In the case of itinerant vendor the fee for a duplicate copy of a licence if the original is
defaced, damaged or lost, shall be Rs 2/-.

Application for renewal of a licence

 Application for renewal of a licence to sell, stock, exhibit or offer for sale or distribute
drugs, after its expiry but within six months of such expiry shall be accompanied by
a fee of Rs 1500/- plus an additional fee at the rate of Rs 500 per month or part
thereof in Form 19.
 Rs 500/- plus an additional fee at the rate of Rs 250/- per month or part thereof in
Form 19-A and Form 19-C
 For itinerant vendor the application for such renewal shall be accompanied by a fee of
Rs 10/-, plus an additional fee at the rate of Rs 8/- per month or part thereof.

Issue of Licence

(4) A licence to sell, stock, exhibit or offer for sale or distribute drugs specified in
Schedule C and C (1) excluding those specified in Schedule X, by are issued in
following forms

S.No Type of Sales Licence Form

1 Retail Form 21
2 Restricted licence Form 21A

62 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
3 Wholesale Form 21B

(5) A licence to sell, stock, exhibit or offer for sale or distribute drugs specified in
Schedule X, by are issued in following forms

S.No Type of Sales Licence Form

1 Retail Form 20F
2 Wholesale Form 20G
(6) If drugs are sold or stocked for sale at more than one place, separate application shall
be made, and a separate licence shall be issued, in respect of each such place.

Restricted licences in Forms 20A and 21A.

(iv) Restricted licences in Forms 20A and 21A shall be issued subject to the discretion of
the Licensing Authority, to dealers or persons in respect of drugs whose sale does not
require the supervision of a qualified person.
(v) Licences to itinerant vendors shall be issued only in exceptional circumstances for
bonafide travelling agents of firms dealing in drugs or for a vendor who purchases
drugs from a licensed dealer for distribution in sparsely populated rural areas where
other channels of distribution of drugs are not available.
(vi) The licensing authority may issue a licence in Form 21A to a travelling agent of a firm
but to no other class of itinerant vendors for the specific purpose of distribution to
medical practitioners or dealers, samples of biological and other special products
specified in Schedule C:

Provided that travelling agents of licensed manufacturers, agents, of such

manufacturers and importers of drugs shall be exempted from taking out licence for the
free distribution of samples of medicines among members of the medical profession,
hospitals, dispensaries and the medical institution or research institutions.

Conditions to be satisfied before a licence in Form 20A or Form 21A is granted

(4) A licence in Form 20A or Form 21A shall not be granted to any person, unless the
authority empowered to grant the licence is satisfied that the premises in respect of
which the licence is to be granted are adequate and equipped with proper storage
accommodation for preserving the properties of drugs to which the licence applies:

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 Pharmaceutical Jurisprudence V SEM
Provided that this condition shall not apply in the case of licence granted to itinerant
vendors.
(5) In granting a licence under Rule 62A the authority empowered to grant it shall have
regard to:
(iii) the number of licences granted in the locality during one year immediately
preceding; and
(iv) the occupation, trade or business carried on by such applicant : Provided that the
licensing authority may refuse to grant or renew a licence to any applicant or
licensee in respect of whom it is satisfied that by reason of his conviction of an
offence under the Act or these Rules or the previous cancellation or suspension of
any licence granted thereunder, he is not a fit person to whom a licence should be
granted under this rule.
(6) Any person who is aggrieved by the order passed by the licensing authority in sub-rule
(1) may, within 30 days from the date of the receipt of such order appeal to the State
Government and the State Government may, after such enquiry into the matter as it
considers necessary and after giving the appellant an opportunity for representing his
views in the matter make such order in relation thereto as it thinks fit.

Licence to sell drugs by wholesale or to distribute the same from a motor vehicle

Application for licence to sell drugs by wholesale or to distribute the same from a motor
vehicle

(1) Application for the grant or renewal of a licence to sell by wholesale or to distribute
from a motor vehicle shall be made to the Licensing Authority in Form 19AA and shall
be accompanied by a fee of Rs 500/-:
Provided that if the applicant applies for the renewal of a licence after its expiry but
within six months of such expiry , the fee payable for renewal of such licence shall be
Rs 500/- plus an additional fee at the rate of Rs 250/- per month or part thereof.
(2) A fee of Rs 150/- shall be paid for a duplicate copy of a licence issued under this rule, if
the original is defaced, damaged or lost.

Form of licences to sell drugs by wholesale or distribute drugs from a motor vehicle.

(2) A licence shall be issued for sale by wholesale or for distribution from a motor vehicle
of drugs as follows

64 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
S.No Category of Drugs Licence Form
1 drugs other than those specified in Schedule and Form 20BB
Schedule C(1)
2 drugs specified in Schedule C and Schedule C(1) Form 21BB

Duration of licence

An original licence or a renewed licence to sell drugs, unless sooner suspended or cancelled,
shall be valid for a period of five years on and from the date on which it is granted or
renewed: Provided that if the application for renewal of licence in force is made before its
expiry or if the application is made within six months of its expiry, after payment of
additional fee, the licence shall continue to be in force until orders are passed on the
application. The licence shall be deemed to have expired if application for its renewal is not
made within six months after its expiry.

Certificate of renewal of a sale licence

(3) The certificate of renewal of a sale licence in Forms 20, 20A, 20B,3[20F, 20G], 21,
21A and 21B shall be issued in Form 21C.
(4) A certificate of renewal of a licence in Form 20BB or Form 21BB shall be issued in
Form 21CC.

Conditions to be satisfied before a licence in Form [20, 20B, 20F, 20G, 21 or 21B] is
granted

(3) A licence in Form [20, 20B, 20F, 20G, 21 or 21B] to sell, stock, exhibit or offer for sale
or distribute drugs shall not be granted or renewed to any person unless the authority
empowered to grant the licence is satisfied that the premises in respect of which the
licence is to be granted or renewed are adequate, equipped with proper storage
accommodation for preserving the properties of the drugs to which the licence applies
and are in charge of a person competent in the opinion of the licensing authority to
supervise and control the sale, distribution and preservation of drugs :
Provided that in the case of a pharmacy a licence in Form 20 or 21 shall not be granted
or renewed unless the licensing authority is satisfied that the requirements prescribed
for a pharmacy in Schedule N have been complied with:

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 Pharmaceutical Jurisprudence V SEM
Provided further that licence in Form 20F shall be granted or renewed only to a
pharmacy and in areas where a pharmacy is not operating, such licence may be granted
or renewed to a chemist and druggist.
(4) In granting or renewing a licence under sub-rule (1) the authority empowered to grant it
shall have regard
(iii) to the average number of licences granted or renewed during the period of 3 years
immediately preceding, and
(iv) to the occupation, trade or business ordinarily carried on by such applicant during
the period aforesaid:

Provided that the licensing authority may refuse to grant or renew a licence to any
applicant or licensee in respect of whom it is satisfied that by reason of his conviction
of an offence under the Act or these rules, or the previous cancellation or suspension of
any licence granted or renewed thereunder, he is not a fit person to whom a licence
should be granted or renewed under this rule. Every such order shall be communicated
to the licensee as soon as possible:

Provided further that in respect of an application for the grant of a licence in Form 20B
or Form 21B or both, the licensing authority shall satisfy himself that the premises in
respect of which a wholesale licence is to be granted or renewed are:-

a. of an area of not less than ten square meters; and

b. in the charge of a competent person, who
i. is a Registered Pharmacist, or
ii. has passed the matriculation examination or its equivalent examination
from a recognised Board with four years‘ experience in dealing with sale of
drugs, or
iii. holds a degree of a recognised University with one year‘s experience in
dealing with drugs:

Provided also that,-

(v) in respect of an application for the grant of a licence in Form 20 or Form 21 or

both, the licensing authority shall satisfy itself that the premises are of an area of
not less than 10 square meters, and
(vi) in respect of an application for the grant of a licence

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 Pharmaceutical Jurisprudence V SEM
(E) In Form 20 or Form 21 or both, and
(F) In Form 20 B or Form 21B or both,

the licensing authority shall satisfy itself that the premises are of an area not less than
15 square meters: Provided also that the provisions of the preceding proviso shall not
apply to the premises for which licences have been issued by the licensing authority
before the commencement of the Drugs and Cosmetics (1st Amendment) Rules, 1997.

(5) Any person who is aggrieved by the order passed by the licensing authority in sub-Rule
(1) may, within 30 days from the date of receipt of such order, appeal to the State
Government and the State Government may, after such enquiry into the matter as it
considers necessary and after giving the appellant an opportunity for representing his
views in the matter, make such an order in relation thereto as it thinks fit.

Condition of licences in Forms 20, 20-A, 20-B, 20-F, 20-G, 21 and 21-B

Licences in Forms 20, 20-A, 20-B, 20-F, 20-G, 21 and 21-B shall be subject to the conditions
stated therein and to the following general conditions

(4) Any drug shall, if compounded or made on the licensee‘s premises be compounded or
made by or under the direct and personal supervision of a registered Pharmacist.
(5) The supply, otherwise than by way of wholesale dealing, of any drug supplied on the
prescription of a Registered Medical Practitioner shall be effected only by or under the
personal supervision of a registered Pharmacist.\
(6) (1) The supply of any drug other than those specified in Schedule X on a prescription of
a Registered Medical Practitioner shall be recorded at the time of supply in a
prescription register specially maintained for the purpose and the serial number of the
entry in the register shall be entered on the prescription. The following particulars shall
be entered in the register:
(viii) serial number of the entry,
(ix) the date of supply,
(x) the name and address of the prescriber,
(xi) the name and address of the patient, or the name and address of the owner
of the animal if the drug supplied is for veterinary use,
(xii) the name of the drug or preparation and the quantity or in the case of a
medicine made up by the licensee, the ingredients and quantities thereof,

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 Pharmaceutical Jurisprudence V SEM
(xiii) in the case of a drug specified in Schedule C or Schedule H and Schedule
H1 the name of the manufacturer of the drug, its batch number and the date
of expiry of potency, if any,
(xiv) the signature of the registered Pharmacist by or under whose supervision
the medicine was made up or supplied: Provided that in the case of drugs
which are not compounded in the premises and which are supplied from or
in the original containers, the particulars specified in items (a) to (g) above
may be entered in a cash or credit memo book, serially numbered and
specially maintained for this purpose:

Provided further that if the medicine is supplied on a prescription on which the

medicine has been supplied on a previous occasion and entries made in the
prescription register, it shall be sufficient if the new entry in the register includes a
serial number, the date of supply, the quantity supplied and a sufficient reference to an
entry in the register recording the dispensing of the medicine on the previous
occasion:

Provided also that it shall not be necessary to record the above details in the register
or in the cash or credit memo particulars in respect of−

(iv) any drugs supplied against prescription under the Employees State Insurance
Scheme if all the above particulars are given in that prescription, and
(v) any drug other than that specified in Schedule C or Schedule H and Schedule H1
if it is supplied in the original unopened container of the manufacturer and if the
prescription is duly stamped at the time of supply with the name of the supplier
and the date on which the supply was made and on condition that the provisions
of sub-rule (4)(3) of this rule are complied with.
(vi) the supply of a drug specified in Schedule H1 shall be recorded in a separate
register at the time of the supply giving the name and address of the prescriber,
the name of the patient, the name of the drug and the quantity supplied and such
records shall be maintained for three years and be open for inspection.
(4) The option to maintain a prescription register or a cash or credit memo book in
respect of drugs and medicines which are supplied from or in the original
container, shall be made in writing to the Licensing Authority at the time of
application for the grant or renewal of the licence to sell by retail:

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 Pharmaceutical Jurisprudence V SEM
Provided that the Licensing Authority may require records to be maintained only in
prescription register if it is satisfied that the entries in the carbon copy of the cash or
credit memo book are not legible.

(6) (1) The supply by retail, otherwise than on a prescription of a drug specified in
Schedule C shall be recorded at the time of supply either−
(v) in a register specially maintained for the purpose in which the following
particulars shall be entered :
(g) serial number of the entry,
(h) the date of supply,
(i) the name and address of the purchaser,
(j) the name of the drug and the quantity thereof,
(k) in the case of a drug specified in Schedule C, the name of the manufacturer,
the batch number and the date of expiry of potency,
(l) the signature of the person under whose supervision the sale was effected,
or
(vi) in a cash or credit memo book, serially numbered containing all the particulars
specified in items (b) to (f) of sub-clause (i) above.

The entries in the carbon copy of the cash or credit memo which is retained by the licensee
shall be maintained in a legible manner.

(4) The option to maintain a register or a cash or credit memo book shall be made in
writing to the Licensing Authority at the time of application for the grant or renewal of
a licence to sell by retail:

Provided that the Licensing Authority may require records to be maintained in a

register if it is satisfied that the entries in the carbon copy of the cash/credit memo book
are not legible.

(5) (i) The supply by retail of any drug shall be made against a cash/credit memo which
shall contain the following particulars :
(7) Name, address and sale licence number of the dealer,
(8) Serial number of the cash/credit memo,
(9) the name and quantity of the drug supplied.

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 Pharmaceutical Jurisprudence V SEM
(iv) Carbon copies of cash/credit memos shall be maintained by the licensee as
record.
(15) (i) Records of purchase of a drug intended for sale or sold by retail shall be maintained
by the licensee and such records shall show the following particulars, namely:
(5) the date of purchase,
(6) the name and address of the person from whom purchased and the number of the
relevant licence held by him,
(7) the name of the drug, the quantity and the batch number, and
(8) the name of the manufacturer of the drug.
(iv) Purchase bills including cash or credit memo shall be serially numbered by the
licensee and maintained by him in a chronological order.
(16) (1) Subject to the other provisions of these Rules the supply of a drug by wholesale
shall be made against a cash or credit memo bearing the name and address of the
licensee and his licence number under the Drugs and Cosmetics Act in which the
following particulars shall be entered
(f) the date of sale,
(g) the name, address of the licensee to whom sold and his sale licence number. In
case of sale to an authority purchasing on behalf of Government, or to a hospital,
medical, educational or research institution or to a Registered Medical
Practitioner for the purpose of supply to his patients the name and address of the
authority, institution or the Registered Medical Practitioner as the case may be,
(h) the name of the drug, the quantity and the batch number,
(i) the name of the manufacturer,
(j) the signature of the competent person under whose supervision the sale was
effected.
(4) Carbon copies of cash or credit memos specified in clause (1) shall be preserved as
records for a period of three years from the date of the sale of the drug.
(5) (i) Records of purchase of a drug intended for resale or sold by wholesale shall be
maintained by the licensee and such records shall show the following particulars,
namely:-
(5) the date of purchase,
(6) the name, address and the number of the relevant licence held by the person
from whom purchased,

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 Pharmaceutical Jurisprudence V SEM
(7) the name of the drug, the quantity and the batch number, and
(8) the name of the manufacturer of the drug.
(iv) Purchase bills including cash or credit memos shall be serially numbered by
the licensee and maintained by him in a chronological order.]
(17) The licensee shall produce for inspection by an Inspector appointed under the Act on
demand all registers and records maintained under these Rules, and shall supply to the
Inspector such information as he may require for the purpose of ascertaining whether
the provisions of the Act and Rules thereunder have been observed.
(18) Except where otherwise provided in these Rules, all registers and records maintained
under these Rules shall be preserved for a period of not less than two years from the
date of the last entry therein.
(19) Notwithstanding anything contained in this Rule it shall not be necessary to record
particulars in a register specially maintained for the purpose if the particulars are
recorded in any other register specially maintained under any other law for the time
being in force.
(20) (a) Substances specified in Schedule H and Schedule H1 or Schedule X shall not be
sold by retail except on and in accordance with the prescription of a Registered Medical
Practitioner and in the case of substances specified in Schedule X, the prescriptions
shall be in duplicate, one copy of which shall be retained by the licensee for a period of
two years.
(b) The supply of drugs specified in Schedule H and Schedule H1 or Schedule X to
Registered Medical Practitioners, Hospitals, Dispensaries and Nursing Homes shall be
made only against the signed order in writing which shall be preserved by the licensee
for a period of two years.
(21) For the purposes of clause (9) a prescription shall
(iv) be in writing an be signed by the person giving it with his usual signature and be
dated by him;
(v) specify the name and address of the person for whose treatment it is given, or the
name and address of the owner of the animal if the drug is meant for veterinary
use;
(vi) indicate the total amount of the medicine to be supplied and the dose to be taken.

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 Pharmaceutical Jurisprudence V SEM
(22) The person dispensing a prescription containing a drug specified in Schedule H and
Schedule H1 and Schedule X shall comply with the following requirements in addition
to other requirement of these rules.
a. the prescription must not be dispensed more than once unless the prescriber has
stated thereon that it may be dispensed more than once;
b. if the prescription contains a direction that it may be dispensed a stated number of
times or at stated intervals it must not be dispensed otherwise than in accordance
with the directions;
c. at the time of dispensing there must be noted on the prescription above the
signature of the prescriber the name and address of the seller and the date on
which the prescription is dispensed.

(11-A) No person dispensing a prescription containing substances specified in Schedule H

and Schedule H1 or X, may supply any other preparation, whether containing the same
substance or not, in lieu thereof.

(23) Substances specified in Schedule X kept in retail shop or premises used in connection
therewith shall be stored—
a. under lock and key in cupboard or drawer reserved solely for the storage of these
substances; or
b. in a part of the premises separated from the remainder of the premises and to
which only responsible persons have access;
(15) (a) The description ―Drugstore‖ shall be displayed by such licensees who do not
require the services of a Registered Pharmacist.
(iii) The description ―Chemists and Druggists‖ shall be displayed by such licensees
who employ the services of a Registered Pharmacist but who do not maintain a
Pharmacy for compounding against prescriptions.
(iv) The description Pharmacy, Pharmacist, Dispensing Chemist or Pharmaceutical
Chemist shall be displayed by such licensees who employ the services of a
Registered Pharmacist and maintain a Pharmacy for compounding against
prescriptions:
(16) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to
record his impressions and the defects noticed.

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 Pharmaceutical Jurisprudence V SEM
(17) No drug shall be sold or stocked by the licensee after the date of expiration of potency
recorded on its container, label or wrapper, or in violation of any statement or direction
recorded on such container, label or wrapper:

Provided that any such drugs in respect of which the licensee has taken steps with the
manufacturer or his representative for the withdrawal, reimbursement or disposal of the
same, may be stocked after the date of expiration of potency pending such withdrawal,
reimbursement or disposal, as the case may be, subject to the condition that the same
shall be stored separately from the trade stocks and all such drugs shall be kept in
packages or cartons, the top of which shall display prominently, the words Not for sale.

(18) No drug intended for distribution to the medical profession as free sample which bears
a label on the container as specified in clause 4[(ix)] of sub-rule (1) of rule 96, and no
drug meant for consumption by the Employees‘ State Insurance Corporation, the
Central Government Health Scheme, the Government Medical Stores Depots, the
Armed Forces Medical Stores or other Government institutions, which bears a
distinguishing mark or any inscription on the drug or on the label affixed to the
container thereof indicating this purpose shall be sold or stocked by the licensee on his
premises:

Provided that this sub-rule shall not be applicable to licensees who have been appointed
as approved chemists, by the State Government in writing, under the employees‘ State
Insurance Scheme, or have been appointed as authorised agent or distributor, by the
manufacturer in writing, for drugs meant for consumption under the Central
Government Health Scheme, the Government Medical Stores Depots, the Armed
Forces Medical Stores or other Government Institutions for drugs meant for
consumption under those schemes or have been appointed as authorised Depots or
Carrying and Forwarding agent by the manufacturer in writing, for storing free samples
meant for distribution to medical profession subject to the conditions that the stock
shall be stored separately from the trade stocks and shall maintain separate records of
the stocks received and distributed by them.

(19) The supply by retail of any drug in a container other than the one in which the
manufacturer has marketed the drug, shall be made only by dealers who employ the
services of a Registered Pharmacist and such supply shall be made under the direct

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 Pharmaceutical Jurisprudence V SEM
supervision of the Registered Pharmacist] in an envelope or other suitable wrapper or
container showing the following particulars on the label:
(iv) name of the drug,
(v) the quantity supplied,
(vi) the name and address of the dealer.]
(20) The medicines for treatment of animals kept in a retail shop or premises shall be
labelled with the words Not for human use and shall be stored for treatment of
animals only.
(c) in a cupboard or drawer reserved solely for the storage of veterinary drugs, or
(d) in a part of the premises separated from the remainder of the premises to which
customers are not permitted to have access.]
(21) (a) The supply of drugs specified in Schedule X shall be recorded at the time of supply
in a register (bound and serially page numbered) specially maintained for the purpose
and separate pages shall be allotted for each drug.
(d) The following particulars shall be entered in the said register, namely:--
(xi) Date of transaction;
(xii) Quantity received, if any, the name and address of the supplier and the
number of the relevant licence held by the supplier;
(xiii) Name of the drug;
(xiv) Quantity supplied;
(xv) Manufacturer‘s name;
(xvi) Batch No. or Lot No;
(xvii) Name and address of the patient/purchaser;
(xviii) Reference Number of the prescription against which supplies were
made;
(xix) Bill No and date in respect of purchases and supplies made by him;
(xx) Signature of the person under whose supervision the drugs have been
supplied.

Restricted license

Applications for the grant or renewal of a licence

The Applications for the grant or renewal of a licence to sell, stock, exhibit or offer for sale or
distribute drugs are given in following forms are as follows

74 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy

 Pharmaceutical Jurisprudence V SEM
S.No Form Category of Drugs Fees
1 Form 19 other than those included in Schedule X Rs 1,500/-
2 Form 19A other than those included in Schedule X Rs 500/-
3 Form 19A Itinerant vendor who desires to establish a shop in a Rs 10/-
village or town having population of 5,000 or less.
4 Form 19C drugs included in Schedule X Rs 500/-
5 Form 20 drugs other than those specified in Schedules C, C Rs 1,500/-
(Retail) (1) and X
6 Form 20 A drugs other than those specified in Schedules C, C Rs 1,500/-
(Restricted (1) and X
Licence)
7 Form 20 B drugs other than those specified in Schedules C, C Rs 1,500/-
(Whole Sale) (1) and X

Duplicate copy of a licence

 A fee of Rs 150/- shall be paid for a duplicate copy of a licence to sell, stock, exhibit
or offer for sale or distribute drugs, other than those included in Schedule X.
 A fee of Rs 150/- shall be paid for a duplicate copy of a licence to sell, stock, exhibit
or offer for sale or distribute drugs, included in Schedule X, if the original is defaced,
damaged or lost.
 In the case of itinerant vendor the fee for a duplicate copy of a licence if the original is
defaced, damaged or lost, shall be Rs 2/-.

Application for renewal of a licence

 Application for renewal of a licence to sell, stock, exhibit or offer for sale or distribute
drugs, after its expiry but within six months of such expiry shall be accompanied by
a fee of Rs 1500/- plus an additional fee at the rate of Rs 500 per month or part
thereof in Form 19.
 Rs 500/- plus an additional fee at the rate of Rs 250/- per month or part thereof in
Form 19-A and Form 19-C
 For itinerant vendor the application for such renewal shall be accompanied by a fee of
Rs 10/-, plus an additional fee at the rate of Rs 8/- per month or part thereof.

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 Pharmaceutical Jurisprudence V SEM
Issue of Licence

(7) A licence to sell, stock, exhibit or offer for sale or distribute drugs specified in
Schedule C and C (1) excluding those specified in Schedule X, by are issued in
following forms

S.No Type of Sales Licence Form

1 Retail Form 21
2 Restricted licence Form 21A
3 Wholesale Form 21B

(8) A licence to sell, stock, exhibit or offer for sale or distribute drugs specified in
Schedule X, by are issued in following forms

S.No Type of Sales Licence Form

1 Retail Form 20F
2 Wholesale Form 20G
(9) If drugs are sold or stocked for sale at more than one place, separate application shall
be made, and a separate licence shall be issued, in respect of each such place.

Restricted licences in Forms 20A and 21A.

(vii) Restricted licences in Forms 20A and 21A shall be issued subject to the discretion of
the Licensing Authority, to dealers or persons in respect of drugs whose sale does not
require the supervision of a qualified person.
(viii) Licences to itinerant vendors shall be issued only in exceptional circumstances for
bonafide travelling agents of firms dealing in drugs or for a vendor who purchases
drugs from a licensed dealer for distribution in sparsely populated rural areas where
other channels of distribution of drugs are not available.
(ix) The licensing authority may issue a licence in Form 21A to a travelling agent of a firm
but to no other class of itinerant vendors for the specific purpose of distribution to
medical practitioners or dealers, samples of biological and other special products
specified in Schedule C:

Provided that travelling agents of licensed manufacturers, agents, of such

manufacturers and importers of drugs shall be exempted from taking out licence for the

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 Pharmaceutical Jurisprudence V SEM
free distribution of samples of medicines among members of the medical profession,
hospitals, dispensaries and the medical institution or research institutions.

Conditions to be satisfied before a licence in Form 20A or Form 21A is granted

(7) A licence in Form 20A or Form 21A shall not be granted to any person, unless the
authority empowered to grant the licence is satisfied that the premises in respect of
which the licence is to be granted are adequate and equipped with proper storage
accommodation for preserving the properties of drugs to which the licence applies:
Provided that this condition shall not apply in the case of licence granted to itinerant
vendors.
(8) In granting a licence under Rule 62A the authority empowered to grant it shall have
regard to:
(v) the number of licences granted in the locality during one year immediately
preceding; and
(vi) the occupation, trade or business carried on by such applicant : Provided that the
licensing authority may refuse to grant or renew a licence to any applicant or
licensee in respect of whom it is satisfied that by reason of his conviction of an
offence under the Act or these Rules or the previous cancellation or suspension of
any licence granted thereunder, he is not a fit person to whom a licence should be
granted under this rule.
(9) Any person who is aggrieved by the order passed by the licensing authority in sub-rule
(1) may, within 30 days from the date of the receipt of such order appeal to the State
Government and the State Government may, after such enquiry into the matter as it
considers necessary and after giving the appellant an opportunity for representing his
views in the matter make such order in relation thereto as it thinks fit.

Licence to sell drugs by wholesale or to distribute the same from a motor vehicle

Application for licence to sell drugs by wholesale or to distribute the same from a motor
vehicle

(1) Application for the grant or renewal of a licence to sell by wholesale or to distribute
from a motor vehicle shall be made to the Licensing Authority in Form 19AA and shall
be accompanied by a fee of Rs 500/-:

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 Pharmaceutical Jurisprudence V SEM
Provided that if the applicant applies for the renewal of a licence after its expiry but
within six months of such expiry , the fee payable for renewal of such licence shall be
Rs 500/- plus an additional fee at the rate of Rs 250/- per month or part thereof.
(2) A fee of Rs 150/- shall be paid for a duplicate copy of a licence issued under this rule, if
the original is defaced, damaged or lost.

Form of licences to sell drugs by wholesale or distribute drugs from a motor vehicle.

(3) A licence shall be issued for sale by wholesale or for distribution from a motor vehicle
of drugs as follows

S.No Category of Drugs Licence Form

1 drugs other than those specified in Schedule and Form 20BB
Schedule C(1)
2 drugs specified in Schedule C and Schedule C(1) Form 21BB

Duration of licence

An original licence or a renewed licence to sell drugs, unless sooner suspended or cancelled,
shall be valid for a period of five years on and from the date on which it is granted or
renewed: Provided that if the application for renewal of licence in force is made before its
expiry or if the application is made within six months of its expiry, after payment of
additional fee, the licence shall continue to be in force until orders are passed on the
application. The licence shall be deemed to have expired if application for its renewal is not
made within six months after its expiry.

Certificate of renewal of a sale licence

(5) The certificate of renewal of a sale licence in Forms 20, 20A, 20B,3[20F, 20G], 21,
21A and 21B shall be issued in Form 21C.
(6) A certificate of renewal of a licence in Form 20BB or Form 21BB shall be issued in
Form 21CC.

Conditions to be satisfied before a licence in Form [20, 20B, 20F, 20G, 21 or 21B] is
granted

(5) A licence in Form [20, 20B, 20F, 20G, 21 or 21B] to sell, stock, exhibit or offer for sale
or distribute drugs shall not be granted or renewed to any person unless the authority

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 Pharmaceutical Jurisprudence V SEM
empowered to grant the licence is satisfied that the premises in respect of which the
licence is to be granted or renewed are adequate, equipped with proper storage
accommodation for preserving the properties of the drugs to which the licence applies
and are in charge of a person competent in the opinion of the licensing authority to
supervise and control the sale, distribution and preservation of drugs :
Provided that in the case of a pharmacy a licence in Form 20 or 21 shall not be granted
or renewed unless the licensing authority is satisfied that the requirements prescribed
for a pharmacy in Schedule N have been complied with:
Provided further that licence in Form 20F shall be granted or renewed only to a
pharmacy and in areas where a pharmacy is not operating, such licence may be granted
or renewed to a chemist and druggist.
(6) In granting or renewing a licence under sub-rule (1) the authority empowered to grant it
shall have regard
(v) to the average number of licences granted or renewed during the period of 3 years
immediately preceding, and
(vi) to the occupation, trade or business ordinarily carried on by such applicant during
the period aforesaid:

Provided that the licensing authority may refuse to grant or renew a licence to any
applicant or licensee in respect of whom it is satisfied that by reason of his conviction
of an offence under the Act or these rules, or the previous cancellation or suspension of
any licence granted or renewed thereunder, he is not a fit person to whom a licence
should be granted or renewed under this rule. Every such order shall be communicated
to the licensee as soon as possible:

Provided further that in respect of an application for the grant of a licence in Form 20B
or Form 21B or both, the licensing authority shall satisfy himself that the premises in
respect of which a wholesale licence is to be granted or renewed are:-

a. of an area of not less than ten square meters; and

b. in the charge of a competent person, who
i. is a Registered Pharmacist, or
ii. has passed the matriculation examination or its equivalent examination
from a recognised Board with four years‘ experience in dealing with sale of
drugs, or

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 Pharmaceutical Jurisprudence V SEM
iii. holds a degree of a recognised University with one year‘s experience in
dealing with drugs:

Provided also that,-

(vii) in respect of an application for the grant of a licence in Form 20 or Form 21 or

both, the licensing authority shall satisfy itself that the premises are of an area of
not less than 10 square meters, and
(viii) in respect of an application for the grant of a licence
(G) In Form 20 or Form 21 or both, and
(H) In Form 20 B or Form 21B or both,

the licensing authority shall satisfy itself that the premises are of an area not less than
15 square meters: Provided also that the provisions of the preceding proviso shall not
apply to the premises for which licences have been issued by the licensing authority
before the commencement of the Drugs and Cosmetics (1st Amendment) Rules, 1997.

(6) Any person who is aggrieved by the order passed by the licensing authority in sub-Rule
(1) may, within 30 days from the date of receipt of such order, appeal to the State
Government and the State Government may, after such enquiry into the matter as it
considers necessary and after giving the appellant an opportunity for representing his
views in the matter, make such an order in relation thereto as it thinks fit.

Condition of licences in Forms 20, 20-A, 20-B, 20-F, 20-G, 21 and 21-B

Licences in Forms 20, 20-A, 20-B, 20-F, 20-G, 21 and 21-B shall be subject to the conditions
stated therein and to the following general conditions

(7) Any drug shall, if compounded or made on the licensee‘s premises be compounded or
made by or under the direct and personal supervision of a registered Pharmacist.
(8) The supply, otherwise than by way of wholesale dealing, of any drug supplied on the
prescription of a Registered Medical Practitioner shall be effected only by or under the
personal supervision of a registered Pharmacist.\
(9) (1) The supply of any drug other than those specified in Schedule X on a prescription of
a Registered Medical Practitioner shall be recorded at the time of supply in a
prescription register specially maintained for the purpose and the serial number of the

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 Pharmaceutical Jurisprudence V SEM
entry in the register shall be entered on the prescription. The following particulars shall
be entered in the register:
(xv) serial number of the entry,
(xvi) the date of supply,
(xvii) the name and address of the prescriber,
(xviii) the name and address of the patient, or the name and address of the
owner of the animal if the drug supplied is for veterinary use,
(xix) the name of the drug or preparation and the quantity or in the case of a
medicine made up by the licensee, the ingredients and quantities thereof,
(xx) in the case of a drug specified in Schedule C or Schedule H and Schedule
H1 the name of the manufacturer of the drug, its batch number and the date
of expiry of potency, if any,
(xxi) the signature of the registered Pharmacist by or under whose supervision
the medicine was made up or supplied: Provided that in the case of drugs
which are not compounded in the premises and which are supplied from or
in the original containers, the particulars specified in items (a) to (g) above
may be entered in a cash or credit memo book, serially numbered and
specially maintained for this purpose:

Provided further that if the medicine is supplied on a prescription on which the

medicine has been supplied on a previous occasion and entries made in the
prescription register, it shall be sufficient if the new entry in the register includes a
serial number, the date of supply, the quantity supplied and a sufficient reference to an
entry in the register recording the dispensing of the medicine on the previous
occasion:

Provided also that it shall not be necessary to record the above details in the register
or in the cash or credit memo particulars in respect of−

(vii) any drugs supplied against prescription under the Employees State Insurance
Scheme if all the above particulars are given in that prescription, and
(viii) any drug other than that specified in Schedule C or Schedule H and Schedule H1
if it is supplied in the original unopened container of the manufacturer and if the
prescription is duly stamped at the time of supply with the name of the supplier

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 Pharmaceutical Jurisprudence V SEM
and the date on which the supply was made and on condition that the provisions
of sub-rule (4)(3) of this rule are complied with.
(ix) the supply of a drug specified in Schedule H1 shall be recorded in a separate
register at the time of the supply giving the name and address of the prescriber,
the name of the patient, the name of the drug and the quantity supplied and such
records shall be maintained for three years and be open for inspection.
(5) The option to maintain a prescription register or a cash or credit memo book in
respect of drugs and medicines which are supplied from or in the original
container, shall be made in writing to the Licensing Authority at the time of
application for the grant or renewal of the licence to sell by retail:

Provided that the Licensing Authority may require records to be maintained only in
prescription register if it is satisfied that the entries in the carbon copy of the cash or
credit memo book are not legible.

(7) (1) The supply by retail, otherwise than on a prescription of a drug specified in
Schedule C shall be recorded at the time of supply either−
(vii) in a register specially maintained for the purpose in which the following
particulars shall be entered :
(m) serial number of the entry,
(n) the date of supply,
(o) the name and address of the purchaser,
(p) the name of the drug and the quantity thereof,
(q) in the case of a drug specified in Schedule C, the name of the manufacturer,
the batch number and the date of expiry of potency,
(r) the signature of the person under whose supervision the sale was effected,
or
(viii) in a cash or credit memo book, serially numbered containing all the particulars
specified in items (b) to (f) of sub-clause (i) above.

The entries in the carbon copy of the cash or credit memo which is retained by the licensee
shall be maintained in a legible manner.

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 Pharmaceutical Jurisprudence V SEM
(6) The option to maintain a register or a cash or credit memo book shall be made in
writing to the Licensing Authority at the time of application for the grant or renewal of
a licence to sell by retail:

Provided that the Licensing Authority may require records to be maintained in a

register if it is satisfied that the entries in the carbon copy of the cash/credit memo book
are not legible.

(7) (i) The supply by retail of any drug shall be made against a cash/credit memo which
shall contain the following particulars :
(10) Name, address and sale licence number of the dealer,
(11) Serial number of the cash/credit memo,
(12) the name and quantity of the drug supplied.
(v) Carbon copies of cash/credit memos shall be maintained by the licensee as
record.
(24) (i) Records of purchase of a drug intended for sale or sold by retail shall be maintained
by the licensee and such records shall show the following particulars, namely:
(9) the date of purchase,
(10) the name and address of the person from whom purchased and the number of the
relevant licence held by him,
(11) the name of the drug, the quantity and the batch number, and
(12) the name of the manufacturer of the drug.
(v) Purchase bills including cash or credit memo shall be serially numbered by the
licensee and maintained by him in a chronological order.
(25) (1) Subject to the other provisions of these Rules the supply of a drug by wholesale
shall be made against a cash or credit memo bearing the name and address of the
licensee and his licence number under the Drugs and Cosmetics Act in which the
following particulars shall be entered
(k) the date of sale,
(l) the name, address of the licensee to whom sold and his sale licence number. In
case of sale to an authority purchasing on behalf of Government, or to a hospital,
medical, educational or research institution or to a Registered Medical
Practitioner for the purpose of supply to his patients the name and address of the
authority, institution or the Registered Medical Practitioner as the case may be,

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 Pharmaceutical Jurisprudence V SEM
(m) the name of the drug, the quantity and the batch number,
(n) the name of the manufacturer,
(o) the signature of the competent person under whose supervision the sale was
effected.
(6) Carbon copies of cash or credit memos specified in clause (1) shall be preserved as
records for a period of three years from the date of the sale of the drug.
(7) (i) Records of purchase of a drug intended for resale or sold by wholesale shall be
maintained by the licensee and such records shall show the following particulars,
namely:-
(9) the date of purchase,
(10) the name, address and the number of the relevant licence held by the person
from whom purchased,
(11) the name of the drug, the quantity and the batch number, and
(12) the name of the manufacturer of the drug.
(v) Purchase bills including cash or credit memos shall be serially numbered by
the licensee and maintained by him in a chronological order.]
(26) The licensee shall produce for inspection by an Inspector appointed under the Act on
demand all registers and records maintained under these Rules, and shall supply to the
Inspector such information as he may require for the purpose of ascertaining whether
the provisions of the Act and Rules thereunder have been observed.
(27) Except where otherwise provided in these Rules, all registers and records maintained
under these Rules shall be preserved for a period of not less than two years from the
date of the last entry therein.
(28) Notwithstanding anything contained in this Rule it shall not be necessary to record
particulars in a register specially maintained for the purpose if the particulars are
recorded in any other register specially maintained under any other law for the time
being in force.
(29) (a) Substances specified in Schedule H and Schedule H1 or Schedule X shall not be
sold by retail except on and in accordance with the prescription of a Registered Medical
Practitioner and in the case of substances specified in Schedule X, the prescriptions
shall be in duplicate, one copy of which shall be retained by the licensee for a period of
two years.

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 Pharmaceutical Jurisprudence V SEM
(b) The supply of drugs specified in Schedule H and Schedule H1 or Schedule X to
Registered Medical Practitioners, Hospitals, Dispensaries and Nursing Homes shall be
made only against the signed order in writing which shall be preserved by the licensee
for a period of two years.
(30) For the purposes of clause (9) a prescription shall
(vii) be in writing an be signed by the person giving it with his usual signature and be
dated by him;
(viii) specify the name and address of the person for whose treatment it is given, or the
name and address of the owner of the animal if the drug is meant for veterinary
use;
(ix) indicate the total amount of the medicine to be supplied and the dose to be taken.
(31) The person dispensing a prescription containing a drug specified in Schedule H and
Schedule H1 and Schedule X shall comply with the following requirements in addition
to other requirement of these rules.
a. the prescription must not be dispensed more than once unless the prescriber has
stated thereon that it may be dispensed more than once;
b. if the prescription contains a direction that it may be dispensed a stated number of
times or at stated intervals it must not be dispensed otherwise than in accordance
with the directions;
c. at the time of dispensing there must be noted on the prescription above the
signature of the prescriber the name and address of the seller and the date on
which the prescription is dispensed.

(11-A) No person dispensing a prescription containing substances specified in Schedule H

and Schedule H1 or X, may supply any other preparation, whether containing the same
substance or not, in lieu thereof.

(32) Substances specified in Schedule X kept in retail shop or premises used in connection
therewith shall be stored—
a. under lock and key in cupboard or drawer reserved solely for the storage of these
substances; or
b. in a part of the premises separated from the remainder of the premises and to
which only responsible persons have access;

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 Pharmaceutical Jurisprudence V SEM
(22) (a) The description ―Drugstore‖ shall be displayed by such licensees who do not
require the services of a Registered Pharmacist.
(v) The description ―Chemists and Druggists‖ shall be displayed by such licensees
who employ the services of a Registered Pharmacist but who do not maintain a
Pharmacy for compounding against prescriptions.
(vi) The description Pharmacy, Pharmacist, Dispensing Chemist or Pharmaceutical
Chemist shall be displayed by such licensees who employ the services of a
Registered Pharmacist and maintain a Pharmacy for compounding against
prescriptions:
(23) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to
record his impressions and the defects noticed.
(24) No drug shall be sold or stocked by the licensee after the date of expiration of potency
recorded on its container, label or wrapper, or in violation of any statement or direction
recorded on such container, label or wrapper:

Provided that any such drugs in respect of which the licensee has taken steps with the
manufacturer or his representative for the withdrawal, reimbursement or disposal of the
same, may be stocked after the date of expiration of potency pending such withdrawal,
reimbursement or disposal, as the case may be, subject to the condition that the same
shall be stored separately from the trade stocks and all such drugs shall be kept in
packages or cartons, the top of which shall display prominently, the words Not for sale.

(25) No drug intended for distribution to the medical profession as free sample which bears
a label on the container as specified in clause 4[(ix)] of sub-rule (1) of rule 96, and no
drug meant for consumption by the Employees‘ State Insurance Corporation, the
Central Government Health Scheme, the Government Medical Stores Depots, the
Armed Forces Medical Stores or other Government institutions, which bears a
distinguishing mark or any inscription on the drug or on the label affixed to the
container thereof indicating this purpose shall be sold or stocked by the licensee on his
premises:

Provided that this sub-rule shall not be applicable to licensees who have been appointed
as approved chemists, by the State Government in writing, under the employees‘ State
Insurance Scheme, or have been appointed as authorised agent or distributor, by the
manufacturer in writing, for drugs meant for consumption under the Central

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 Pharmaceutical Jurisprudence V SEM
Government Health Scheme, the Government Medical Stores Depots, the Armed
Forces Medical Stores or other Government Institutions for drugs meant for
consumption under those schemes or have been appointed as authorised Depots or
Carrying and Forwarding agent by the manufacturer in writing, for storing free samples
meant for distribution to medical profession subject to the conditions that the stock
shall be stored separately from the trade stocks and shall maintain separate records of
the stocks received and distributed by them.

(26) The supply by retail of any drug in a container other than the one in which the
manufacturer has marketed the drug, shall be made only by dealers who employ the
services of a Registered Pharmacist and such supply shall be made under the direct
supervision of the Registered Pharmacist] in an envelope or other suitable wrapper or
container showing the following particulars on the label:
(vii) name of the drug,
(viii) the quantity supplied,
(ix) the name and address of the dealer.]
(27) The medicines for treatment of animals kept in a retail shop or premises shall be
labelled with the words Not for human use and shall be stored for treatment of
animals only.
(e) in a cupboard or drawer reserved solely for the storage of veterinary drugs, or
(f) in a part of the premises separated from the remainder of the premises to which
customers are not permitted to have access.]
(28) (a) The supply of drugs specified in Schedule X shall be recorded at the time of supply
in a register (bound and serially page numbered) specially maintained for the purpose
and separate pages shall be allotted for each drug.
(e) The following particulars shall be entered in the said register, namely:--
(xxi) Date of transaction;
(xxii) Quantity received, if any, the name and address of the supplier and the
number of the relevant licence held by the supplier;
(xxiii) Name of the drug;
(xxiv) Quantity supplied;
(xxv) Manufacturer‘s name;
(xxvi) Batch No. or Lot No;
(xxvii) Name and address of the patient/purchaser;

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 Pharmaceutical Jurisprudence V SEM
(xxviii) Reference Number of the prescription against which supplies were
made;
(xxix) Bill No and date in respect of purchases and supplies made by him;
(xxx) Signature of the person under whose supervision the drugs have been
supplied.

The Drugs Technical Advisory Board (DTAB)

The Central Government shall, as soon as may be, constitute a the Drugs Technical Advisory
Board to advise the Central Government and the State Governments on technical matters
arising out of the administration of this Act and to carry out the other functions assigned to it
by this Act.
Composition of DTAB
The Board shall consist of the following members, namely:—
Ex officio Members
S.No Members
1 The Director General of Health Services, ex officio, who shall be Chairman; (ii)
the Drugs Controller, India
2 The Director of the Central Drugs Laboratory, Calcutta
3 The Director of the Central Research Institute, Kasauli
4 The Director of Indian Veterinary Research Institute, Izatnagar
5 The President of Medical Council of India
6 The President of the Pharmacy Council of India
7 The Director of Central Drug Research Institute, Lucknow

Nominated Members
S.No Members
1 Two persons to be nominated by the Central Government from among persons
who are in charge of drugs control in the States
2 One person to be nominated by the Central Government from the pharmaceutical
industry
3 Two persons holding the appointment of Government Analyst under this Act, to
be nominated by the Central Government

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 Pharmaceutical Jurisprudence V SEM
Elected Members
S.No Members
1 One person, to be elected by the Executive Committee of the Pharmacy Council
of India, from among teachers in pharmacy or pharmaceutical chemistry or
pharmacognosy on the staff of an Indian university or a college affiliated thereto;
2 One person, to be elected by the Executive Committee of the Medical Council of
India, from among teachers in medicine or therapeutics on the staff of an Indian
university or a college affiliated thereto;
3 One pharmacologist to be elected by the Governing Body of the Indian Council of
Medical Research
4 One person to be elected by the Central Council of the Indian Medical
Association
5 One person to be elected by the Council of the Indian Pharmaceutical Association
 The nominated and elected members of the Board shall hold office for three years, but
shall be eligible for re- nomination and re-election:
 The Board may, subject to the previous approval of the Central Government, make
bye-laws fixing a quorum and regulating its own procedure and the conduct of all
business to be transacted by it.
 The Board may constitute sub-committees and may appoint to such sub-committees
for such periods, not exceeding three years, as it may decide, or temporarily for the
consideration of particular matters, persons who are not members of the Board.
 The functions of the Board may be exercised notwithstanding any vacancy therein.
 The Central Government shall appoint a person to be Secretary of the Board and shall
provide the Board with such clerical and other staff as the Central Government
considers necessary.
The Drugs Consultative Committee (DCC)
The Central Government may constitute an advisory committee to be called the Drugs
Consultative Committee to advise the Central Government, the State Governments and the
Drugs Technical Advisory Board on any other matter tending to secure uniformity throughout
in the administration of this Act.

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 Pharmaceutical Jurisprudence V SEM
Composition of DCC
The Drugs Consultative Committee shall consist of
 Two representatives of the Central Government to be nominated by that Government
and
 One representative of each State Government to be nominated by the State
Government concerned.
The Drugs Consultative Committee shall meet when required to do so by the Central
Government and shall have power to regulate its own procedure.
The Central Drugs Laboratory (CDL)
The Central Government shall, as soon as may be, established a Central Drugs Laboratory
under the control of a Director to be appointed by the Central Government, to carry out the
functions entrusted to it by this Act or any rules made under this Chapter.
Functions of CDL
The functions of the Central Drugs Laboratory in respect of any drug or class of drugs or
cosmetic or class of cosmetics shall be carried out at the Central Research Institute, Kasauli,
or at any other prescribed Laboratory and the functions of the Director of the Central Drugs
Laboratory in respect of such drug or class of drugs or such cosmetic or class of cosmetics
shall be exercised by the Director of that Institute or of that other Laboratory, as the case may
be.
(i) to analyse or test such samples of drugs as may be sent to it under sub- section (2) of
section 11, or under sub-section (4) of section 25 of the Act;
(ii) to carry out such other duties as may be entrusted to it by the Central Government
or, with the permission of the Central Government, by a State Government after
consultation with the Drugs Technical Advisory Board.
Functions of Central Research Institute, Kasauli
(1) The functions of the Laboratory in respect of the following drugs or classes of drugs
shall be carried out at the Central Research Institute, Kasauli, and the functions of
the Director in respect of the said drugs or classes of drugs shall be exercised by the
Director of the said Institute :
a. Sera.
b. Solution of serum proteins intended for injection.
c. Vaccines.
d. Toxins.

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 Pharmaceutical Jurisprudence V SEM
e. Antigens.
f. Anti-toxins.
g. Sterilized surgical ligature and sterilised surgical suture.
h. Bacteriophages:
Provided that the functions of the Director in respect of Oral Polio Vaccine shall be exercised
by the Deputy Director and Head of the Polio Vaccine Testing Laboratory in case of Central
Research Institute, Kasauli only.
The functions of the Laboratory in respect of Oral Polio Vaccine shall be carried out by the
following Institutes and the functions of the Director in respect of the said drugs shall be
exercised by the Director of the respective Institutes :-
(a) Pasteur Institute of India, Coonoor.
(b) Enterovirus Research Centre (Indian Council of Medical Research), Haffkin Institute
Compound, Parel, Bombay-400012.
(c) The National Institute of Biologicals, NOIDA.
Functions of Indian Veterinary Research Institute, Izatnagar
The functions of the Laboratory in respect of the following drugs or classes of drugs shall be
carried out at the Indian Veterinary Research Institute, Izatnagar or Mukteshwar and the
functions of the Director in respect of the said drugs or classes of drugs shall be exercised by
the Director of either of the said institutes.
(1) Anti-sera for veterinary use.
(2) Vaccines for veterinary use.
(3) Toxoids for veterinary use.
(4) Diagnostic Antigens for veterinary use.
Functions of Central Drugs Testing Laboratory, Chennai
The functions of the laboratory in respect of testing of condoms shall be carried out at the
Central Drugs Testing Laboratory, Chennai, and the functions of the Director in respect of the
said products shall be exercised by the Director of the said Laboratory.
Functions of Laboratory of the Serologist and Chemical Examiner to the Government
of India, Calcutta
The functions of the Laboratory in respect of the following drug shall be carried out at the
Laboratory of the Serologist and Chemical Examiner to the Government of India, Calcutta
and the functions of the Director in respect of the said drug shall be performed by the
Serologist and Chemical Examiner of the said Laboratory : VDRL Antigen.

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Functions of Central Drugs Testing Laboratory, Thane
The function of the Laboratory in respect of Intra-Utrine Devices and Falope Rings shall be
carried out at the Central Drugs Testing Laboratory, Thane, Maharashtra and the functions of
the Director in respect of the said devices shall be exercised by the Director of the said
Laboratory.
Functions in respect of human blood and human blood products
The functions of the Laboratory in respect of human blood and human blood products
including components, to test for freedom of HIV antibodies, shall be carried out by the
following Institutes/Hospitals and the functions of the Director in respect of the above
mentioned products shall be exercised by the head of the respective Institute, namely:-
(a) National Institute for Communicable Disease, Department of Microbiology, Delhi.
(b) National Institute of Virology, Pune
(c) Centre of Advanced Research in Virology, Christian Medical College, Vellore.
Functions of Homoeopathic medicines
The functions of the Laboratory in respect of Homoeopathic medicines shall be carried out at
the Homoeopathy Pharmacopoeia Laboratory, Ghaziabad and the functions of the Director in
respect of the Homoeopathic medicines shall be exercised by the Director of the laboratory.
Functions of National Institute of Biologicals, Noida
The functions of the Laboratory in respect of the following kits or class of drugs shall be
carried out at the National Institute of Biologicals, Noida and the functions of the Director in
respect of the said drugs or class of drugs shall be exercised by the Director of the said
institute.
The kits or class of drugs referred to in clause (a) are-
(1) Blood grouping reagents.
(2) Diagnostic kits for human immunodeficiency virus, Hepatitis B Surface Antigen and
Hepatitis C Virus.
(3) Blood products-
a) Human Albumin;
b) Human Normal Immunoglobulin (intramuscular and intravenous);
c) Human Coagulation Factor VIII;
d) Human Coagulation Factor IX;
e) Plasma Protein Fractionation;
f) Fibrin Sealant Kit;

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 Pharmaceutical Jurisprudence V SEM
g) Anti Inhibitor Coagulation complex.
(4) Recombinant products such as-
a) Recombinant insulin and insulin analogue;
b) r-erythropoietin (EPO);
c) r-Granulocyte Colony stimulating Factor (G-CSF).
(5) Biochemical kits-
a) Glucose Test Strips;
b) Fully Automated analyzer based glucose reagents.]
Despatch of samples for test or analysis.-
(1) Samples for test or analysis under sub-section (4) of section 25 of the Act shall be
sent by registered post in a sealed packet, enclosed, together with a memorandum in
Form 1, in an outer cover addressed to the Director.
(2) The packet as well as the outer cover, shall be marked with a distinguishing number.
(3) A copy of the memorandum in Form 1 and a specimen impression of the seal used to
seal the packet shall be sent separately by registered post to the Director.
Recording of condition of seals
On receipt of the packet, it shall be opened by an officer authorised in writing in that behalf
by the Director who shall record the condition of the seal on the packet.
Report of result of test or analysis
After test or analysis the result of the test or analysis, together with full protocols of the tests
applied, shall be supplied forthwith to the sender in Form 2.
Fees
The fees for test and analysis shall be those specified in Schedule B.
Signature of certificates
Certificates issued under these Rules by the Laboratory shall be signed by the Director or by
an officer authorised by the Central Government by Notification in the Official Gazette to
sign such certificates.

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 Pharmaceutical Jurisprudence V SEM
Government Analysts
Appointment of Government Analysts
1. The State Government may, by notification in the Official Gazette, appoint such
persons as it thinks fit, having the prescribed qualifications, to be Government
Analysts for such areas in the state and in respect of such drugs or classes of drugs or
such cosmetics or classes of cosmetics as may be specified in the notification.
2. The Central Government may also, by notification in the Official Gazette, appoint
such persons as it thinks fit, having the prescribed qualifications, to be Government
Analysts in respect of such drugs or classes of drugs or such cosmetics or classes of
cosmetics as may be specified in the notification.
3. Notwithstanding anything contained in sub-section (1) or sub-section (2), neither the
Central Government nor a State Government shall appoint as a Government Analyst
any official not serving under it without the previous consent of the Government
under which he is serving.
4. No person who has any financial interest in the import, manufacture or sale of drugs
or cosmetics shall be appointed to be a Government Analyst under sub-section (1) or
sub-section (2) of this section.
Qualifications of Government Analyst.
A person appointed as a Government Analyst under the Act shall be a person who
(a) is a graduate in medicine or science or pharmacy or Pharmaceutical Chemistry of a
University established in India by law or has an equivalent qualification recognized
and notified by the Central Government for such purpose and has had not less than
five years‘ post-graduate experience in the testing of drugs in a laboratory under
control of (i) a Government Analyst appointed under the Act, or (ii) the head of an
Institution or testing laboratory approved for the purpose by the appointing authority,
or has completed two years‘ training on testing of drugs, including items stated in
Schedule C, in Central Drugs Laboratory, or
(b) possesses a post-graduate degree in medicine or science or pharmacy or
Pharmaceutical chemistry of a University established in India by law or has an
equivalent qualification recognized and notified by the Central Government for such
purpose or possesses the Associateship Diploma of the Institution of Chemists (India)
obtained by passing the said examination with 'Analysis of Drugs and
Pharmaceuticals‘ as one of the subjects and has had after obtaining the said post-

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 Pharmaceutical Jurisprudence V SEM
graduate degree or diploma not less than three years‘ experience in the testing of
drugs in a laboratory under the control of (i) a Government Analyst appointed under
the Act, or (ii) the head of an Institution or testing laboratory approved for the
purpose by the appointing authority 4[or has completed training on testing of drugs,
including items stated in Schedule C, in Central Drugs Laboratory:
Provided that-
(i) for purpose of examination of items in Schedule C,-
(ia) the persons appointed under clause (a) or (b) and having degree in
Medicine, Physiology, Pharmacology, Microbiology, Pharmacy should have
experience or training in testing of said items in an institution or laboratory
approved by the appointing authority for a period of not less than six months;
(ib) the person appointed under clause(a) or (b) but not having degree in the
above subjects should have experience or training in testing of said Schedule
C drugs for a period of not less than three years in an institution or laboratory
approved by the appointing authority or have completed two years training on
testing of drugs including items stated in Schedule C in Central Drugs
Laboratory;
(ii) for a period of four years from the date on which Chapter IV of the Act takes
effect in the States, persons whose training and experience are regarded by the
appointing authority as affording, subject to such further training, if any, as may
be considered necessary, a reasonable guarantee of adequate knowledge and
competence, may be appointed as Government Analysts. The persons so
appointed may, if the appointing authority so desires, continue in service after the
expiry of the said period of four years;
(iii) no person who is engaged directly or indirectly in any trade or business connected
with the manufacture of drugs shall be appointed as a Government Analyst for any
area:
Provided further that for the purpose of examination of Anti-sera, Toxoid and
Vaccines and Diagnostic Antigens for Veterinary use, the person appointed
shall be a person who is a graduate in Veterinary Science, or general science,
or medicine or pharmacy and has had not less than five years‘ experience in
the standardization of biological products or person holding a post-graduate
degree in Veterinary Science, or general science, or medicine or pharmacy or

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 Pharmaceutical Jurisprudence V SEM
pharmaceutical chemistry with an experience of not less than three years in the
standardization of biological products :
Provided also that persons, already appointed as Government Analysts may
continue to remain in service, if the appointing authority so desires,
notwithstanding the fact that they do not fulfil the qualifications as laid down
in clause (a), clause (b) or the preceding proviso.
Duties of Government Analysts.
1) The Government Analyst shall cause to be analysed or tested such samples or drugs
and cosmetics as may be sent to him by Inspectors or other persons under the
provisions of Chapter IV of the Act and shall furnish reports of the results of test or
analysis in accordance with these Rules.
2) A Government Analyst shall from time to time forward to the Government reports
giving the result of analytical work and research with a view to their publication at the
discretion of Government.
Procedure on receipt of sample.
On receipt of a package from an Inspector containing a sample for test or analysis, the
Government Analyst shall compare the seals on the packet or on portion of sample or
container with the specimen impression received separately and shall note the condition of
the seals on the packet or on portion of sample or container.
After the test or analysis has been completed, he shall forthwith supply to the Inspector a
report in triplicate in Form 13 of the result of the test or analysis, together with full protocols
of the tests or analysis applied:
It shall be deemed to be full and sufficient compliance with the requirement of the rule in
respect of the supply of ―protocols of the tests or analysis applied‖, if
1) for pharmacopoeial drug, where the tests or methods of analysis prescribed in the
official pharmacopoeia are followed, references to the specific tests or analysis in the
pharmacopoeias are given in the report;
2) for patent or proprietary medicines for which the tests and methods prescribed in any
of the official pharmacopoeias are applicable and are followed, references to the
specific tests or analysis in the pharmacopoeias are given in the report;
3) for patent or proprietary medicines containing pharmacopoeial drugs for which the
official tests or analysis or methods of assays are modified and applied, a description

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of the actual tests or, as the case may be, analysis or methods of assays so applied is
given in the report;
4) for patent or proprietary medicines for which no pharmacopoeial tests or methods of
analysis are available or can be applied but for which tests or methods of analysis
given in standard books or journals are followed, a description of such tests or
methods of analysis applied together with the reference to the relevant books or
journals from which the tests or methods of analysis have been adopted, is given in
the report;
5) for those drugs for which methods of test are not available and have been evolved by
the Government Analyst, a description of tests applied is given in the report.
Report of result of test or analysis.
An application from a purchaser for test or analysis of a drug under section 26 of the Act
shall be made in Form 14 A and the report of test or analysis of the drug made on such
application shall be supplied to the applicant in Form 14B.
Reports of Government Analysts.
1) The Government Analyst to whom a sample of any drug or cosmetic has been
submitted for test or analysis under sub-section (4) of section 23, shall deliver to the
Inspector submitting it a signed report in triplicate in the prescribed form.
2) The Inspector on receipt thereof shall deliver one copy of the report to the person
from whom the sample was taken and another copy to the person, if any, whose name,
address and other particulars have been disclosed under section 18A, and shall retain
the third copy for use in any prosecution in respect of the sample.
3) Any document purporting to be a report signed by a Government Analyst under this
Chapter shall be evidence to the facts stated therein, and such evidence shall be
conclusive unless the person from whom the sample was taken or the person whose
name, address and other particulars have been disclosed under section 18A has, within
twenty-eight days of the receipt of a copy of the report, notified in writing the
Inspector or the Court before which any proceedings in respect of the sample are
pending that he intends to adduce evidence in controversion of the report.
4) Unless the sample has already been tested or analysed in the Central Drugs
Laboratory, where a person has under sub-section (3) notified his intention of
adducing evidence in controversion of a Government Analyst‘s report, the Court may,
of its own motion or in its discretion at the request either of the complainant or the

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 Pharmaceutical Jurisprudence V SEM
accused, cause the sample of the drug or cosmetic produced before the Magistrate
under sub-section (4) of section 23 to be sent for test or analysis to the said
Laboratory, which shall make the test or analysis and report in writing signed by, or
under the authority of, the Director of the Central Drugs Laboratory the result thereof,
and such report shall be conclusive evidence of the facts stated therein.
5) The cost of a test or analysis made by the Central Drugs Laboratory under sub-section
(4) shall be paid by the complainant or accused as the Court shall direct.
Fees.
The fees to be paid by a person submitting to the Government Analyst under section 26 of the
Act for test or analysis of a drug or cosmetic purchased by him shall be those specified in
Schedule B.

Inspectors
Appointment of Inspectors
1) The Central Government or a State Government may, by notification in the Official
Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to
be Inspectors for such areas as may be assigned to them by the Central Government or
State Government, as the case may be.
2) The powers which may be exercised by an Inspector and the duties which may be
performed by him, the drugs or classes of drugs or cosmetics or classes of cosmetics
in relation to which and the conditions, limitations or restrictions subject to which,
such powers and duties may be exercised or performed shall be such as may be
prescribed.
3) No person who has any financial interest in the import, manufacture or sale of drugs
or cosmetics shall be appointed to be an Inspector under this section.
4) Every Inspector shall be deemed to be public servant within the meaning of section 21
of the Indian Penal Code (45 of 1860), and shall be officially subordinate to such
authority having the prescribed qualifications, as the Government appointing him may
specify in this behalf.
Qualifications of Inspectors.
A person who is appointed an Inspector under the Act shall be a person who has a degree in
Pharmacy or Pharmaceutical Sciences or Medicine with specialisation in Clinical
Pharmacology or Microbiology from a University established in India by law:

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Provided that only those Inspectors: ⎯
(i) Who have not less than 18 months‘ experience in the manufacture of at least one of
the substances specified in Schedule C, or
(ii) Who have not less than 18 months‘ experience in testing of at least one of the
substances in Schedule C in a laboratory approved for this purpose by the licensing
authority, or
(iii)Who have gained experiences of not less than three years in the inspection of firms
manufacturing any of the substances specified in Schedule C during the tenure of their
services as Drugs Inspectors; shall be authorised to inspect the manufacture of the
substances mentioned in Schedule C:
Provided further that the requirement as to the academic qualification shall not apply to
persons appointed as Inspectors on or before the 18th day of October, 1993.
Powers of Inspectors
1) Subject to the provisions of section 23 and of any rules made by the Central
Government in this behalf, an Inspector may, within the local limits of the area for
which he is appointed,—
(a) inspect,—
(i) any premises wherein any drug or cosmetic is being manufactured and the means
employed for standardising and testing the drug or cosmetic;
(ii) any premises wherein any drug or cosmetic is being sold, or stocked or exhibited
or offered for sale, or distributed;
(b) take samples of any drug or cosmetic,—
(i) which is being manufactured or being sold or is stocked or exhibited or offered for
sale, or is being distributed;
(ii) from any person who is in the course of conveying, delivering or preparing to
deliver such drug or cosmetic to a purchaser or a consignee;
(c) at all reasonable times, with such assistance, if any, as he considers necessary,--
(i) search any person, who, he has reason to believe, has secreted about his person,
any drug or cosmetic in respect of which an offence under this Chapter has been,
or is being, committed; or
(ii) enter and search any place in which he has reason to believe that an offence under
this Chapter has been, or is being, committed; or

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(iii) stop and search any vehicle, vessel or other conveyance which, he has reason to
believe, is being used for carrying any drug or cosmetic in respect of which an
offence under this Chapter has been, or is being, committed, and order in writing
the person in possession of the drug or cosmetic in respect of which the offence
has been, or is being, committed, not to dispose of any stock of such drug or
cosmetic for a specified period not exceeding twenty days, or, unless the alleged
offence is such that the defect may be removed by the possessor of the drug or
cosmetic, seize the stock of such drug or cosmetic and any substance or article by
means of which the offence has been, or is being, committed or which may be
employed for the commission of such offence;
(cc) examine any record, register, document or any other material object found with
any person, or in any place, vehicle, vessel or other conveyance referred to in clause
(c), and seize the same if he has reason to believe that it may furnish evidence of the
commission of an offence punishable under this Act or the rules made thereunder;
(cca) require any person to produce any record, register, or other document
relating to the manufacture for sale or for distribution, stocking, exhibition for
sale, offer for sale or distribution of any drug or cosmetic in respect of which
he has reason to believe that an offence under this Chapter has been, or is
being, committed;
(d) exercise such other powers as may be necessary for carrying out the purposes of this
Chapter or any rules made thereunder.
2) The provisions of the Code of Criminal Procedure, 1973 (2 of 1974) shall, so far as
may be, apply to any search or seizure under this Chapter as they apply to any search
or seizure made under the authority of a warrant issued under section 94 of the said
Code.
(2A) Every record, register or other document seized under clause (cc) or produced
under clause (cca) shall be returned to the person, from whom they were seized or
who produce the same, within a period of twenty days of the date of such seizure or
production, as the case may be, after copies thereof or extracts therefrom certified by
that person, in such manner as may be prescribed, have been taken.
3) If any person wilfully obstructs an Inspector in the exercise of the powers conferred
upon him by or under this Chapter, or refuses to produce any record, register or other
document when so required under clause (cca) of sub- section (1), he shall be

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 Pharmaceutical Jurisprudence V SEM
punishable with imprisonment which may extend to three years, or with fine, or with
both.
Procedure of Inspectors.
1) Where an Inspector takes any sample of a drug 3[or cosmetic] under this Chapter, he
shall tender the fair price thereof and may require a written acknowledgment therefor.
2) Where the price tendered under sub-section (1) is refused, or where the Inspector
seizes the stock of any drug 3[or cosmetic] under clause (c) of section 22, he shall
tender a receipt therefor in the prescribed form.
3) Where an Inspector takes a sample of a drug 3[or cosmetic] for the purpose of test or
analysis, he shall intimate such purpose in writing in the prescribed form to the person
from whom he takes it and, in the presence of such person unless he wilfully absents
himself, shall divide the sample into four portions and effectively seal and suitably
mark the same and permit such person to add his own seal and mark to all or any of
the portions so sealed and marked:
Provided that where the sample is taken from premises whereon the drug or
cosmetic is being manufactured, it shall be necessary to divide the sample into three
portions only:
Provided further that where the drug or cosmetic is made up in containers of small
volume, instead of dividing a sample as aforesaid, the Inspector may, and if the drug
or cosmetic be such that it is likely to deteriorate or be otherwise damaged by
exposure shall, take three or four, as the case may be, of the said containers after
suitably marking the same and, where necessary, sealing them.
4) The Inspector shall restore one portion of a sample so divided or one container, as the
case may be, to the person from whom he takes it, and shall retain the remainder and
dispose of the same as follows:—
(i) one portion or container he shall forthwith send to the Government Analyst for
test or analysis;
(ii) the second he shall produce to the Court before which proceedings, if any, are
instituted in respect of the drug or cosmetic;
(iii) the third, where taken, he shall send to the person, if any, whose name, address
and other particulars have been disclosed under section 18A.
5) Where an Inspector takes any action under clause (c) of section 22,—

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 Pharmaceutical Jurisprudence V SEM
(a) he shall use all despatch in ascertaining whether or not the drug or cosmetic
contravenes any of the provisions of the section 18 and, if it is ascertained that the
drug or cosmetic does not so contravene, forthwith revoke the order passed under
the said clause or, as the case may be, take such action as may be necessary for the
return of the stock seized;
(b) if he seizes the stock of the drug or cosmetic, he shall as soon as may be inform a
Judicial Magistrate and take his orders as to the custody thereof;
(c) without prejudice to the institution of any prosecution, if the alleged contravention
be such that the defect may be remedied by the possessor of the drug or cosmetic,
he shall, on being satisfied that the defect has been so remedied, forthwith revoke
his order under the said clause.
6) Where an Inspector seizes any record, register, document or any other material object
under clause (cc) of sub- section (1) of section 22, he shall, as soon as may be, inform
a Judicial Magistrate] and take his orders as to the custody thereof.

102 Prepared by Dr.A.G.Hariharan, Professor, K.M. College of Pharmacy