PHARMACEUTICAL JURISPRUDENCE(BP505T)

Third Year B.Pharmacy

Unit I: Drugs and Cosmetics Act, 1940 and its

rules 1945

MS. Sujata Bote

M. Pharm
(Pharmaceutical Chemistry)
Assistant Professor
Sanjay Ghodawat University, Kolhapur
BP505T-UNIT-I 10 Hours

Drugs and Cosmetics Act, 1940 and its rules 1945:

Objectives, Definitions, Legal definitions of schedules to the Act and Rules
Import of drugs – Classes of drugs and cosmetics prohibited from import,
Import under license
or permit. Offences and penalties.
Manufacture of drugs – Prohibition of manufacture and sale of certain drugs,
Conditions for grant of license and conditions of license for manufacture of
drugs, Manufacture of drugs for test, examination and analysis, manufacture of
new drug, loan license and repacking license.
Introduction:
manufacture, sale and distribution. The Central Government and State
Government are charged with the responsibility of providing the drugs of
desired quality to the needy patients and in order to ensure this primary
obligation of the Government, the network is required to be developed to root
out adulterated, misbranded and spurious drugs from the society.

Objectives :
1. For preventing substandard in drugs, probably for treatment and preserving
high medical standards.
2. For controlling the import, manufacture, distribution, and sale of drugs and
cosmetics by licensing.
3. For ensuring that manufacture, distribution, and sale of drugs and cosmetics is
done by qualified persons only.
4. For controlling the manufacture, and sale of Ayurvedic, Siddha, and Unani
drugs.
5. Establishment of Drugs Technical Advisory Board (DTAB) and Drugs
Consultive Committees (DCC) for Allopathic and Allied drugs and Cosmetics
Important Definitions :

1. Drug
It Includes:
(i) All medicines for internal or external use of human beings or animals and substances
used for or in the diagnosis, treatment, mitigation or prevention of any disease or
disorder in human beings or animals including, preparations applied on human body for
the purpose of repelling insects like mosquitoes.

(ii) The substances other than food which may affect the structure or any function of the
human body or used for the destruction of insects or vermin which cause disease in
human beings or animals as specified from time to time by the Central Government by
notification in the Official Gazette.

(iii) The substances used as components of a drug including, empty gelatin capsules.

(iv) The devices used for internal or external use in the diagnosis, treatment, mitigation
or
prevention of disease or disorder in human beings or animals, as may be specified from
time to time by the Central Government by notification in the Official Gazette after
consultation with the Drugs Technical Advisory Board (DTAB).
2. Cosmetic
It means any article intended to be sprayed, poured, rubbed or sprinkled on, or
introduced into, or applied to the human body or its any part for cleansing,
beautifying, promoting attractiveness or altering the appearance. It also includes
any articles intended for use as a component of cosmetic.

3. Ayurvedic, Siddha or Unani Drugs

These include all medicines used for internal or external purposes or used in the
diagnosis, treatment, mitigation or prevention of disease or disorder in human
beings or animals and manufactured exclusively in accordance with the
formulae described in the authoritative books of Ayurvedic, Siddha and Unani
Tibby Systems of Medicines specified in the First Schedule to the Drugs and
Cosmetics Act, 1940.

4. Gudakhu
It is a tobacco product used for rubbing against human teeth. It contains tobacco
powder, lime and molasses along with red mineral matter. It is a cosmetic
within the provisions of the Act.
5. Patent or Proprietary Medicine
(i) In relation to Ayurvedic, Siddha or Unani System of Medicine, all
formulations containing only such ingredients mentioned in the formulae
described in the authoritative books of Ayurvedic, Siddha or Unani System of
Medicine specified in First Schedule to the Act but does not include the
medicine .administered by parenteral route.
(ii) In relation to any other system of medicine including, allopathic, a drug
presented in a form ready for internal or external administration of human
beings or animals and which is not included for the time being in the editions of
Indian Pharmacopoeia or any other Pharmacopoeia.

6. Misbranded Drug
A drug is considered as a misbranded drug:
(i) if it is not labeled in the prescribed manner, or
(ii) if it is so colored, coated, powdered or polished that damage is concealed or
it is made to appear of better or greater therapeutic value than it really is, or
(iii) if the label or container or anything accompanying the drug bears any
statement, design or device which makes any false claim for the drug or gives
misleading information.
7. Adulterated Drug
A drug is considered to be adulterated:
(i) if it consists in whole or in part of any filthy, putrid, or decomposed
substance,or
(ii) if it has been prepared, packed or stored under poor sanitary conditions
whereby, it may have been contaminated with filth and rendered injurious to
health, or
(iii) if container of the drug is composed in whole or in part of any poisonous
substance which may render the contents injurious to health, or
(iv) if it contains a color other than one which is prescribed, or
(v) if the drug contains any harmful or toxic substance which may render it
injurious to health, or
(vi) if the drug is admixed with any substance so as to reduce its quality or
strength.

8. Manufacture in relation to Drug or Cosmetic

Any process fully or partly used for making, altering, ornamenting, finishing
packing, labeling, breaking up or otherwise treating or adopting any drug/cosmetic
with a view to its sale or distribution but, does not include the compounding or
dispensing of any drug or the packing of any drug or cosmetic in the ordinary
9. Spurious Drug
A drug is deemed to be a spurious drug:
(i) if it is imported under a name which belongs to another drug, or
(ii) if it is an imitation of or a substitute for another drug or if it resembles
another drug in a manner likely to deceive or bears upon it or its label or
container the name of another drug, or
(iii) if it has been substituted wholely or in part by another drug substance, or
(iv) if it claims to be the product of a manufacturer or company of whom it is
not truly a product.

10. Misbranded Cosmetic

A cosmetic shall be deemed to be misbranded:
(i) if it contains a color which is not prescribed, or
(ii) if it is not labeled in prescribed manner, or
(iii) if the label or container or anything accompanying the cosmetic bears any
statement which is false or misleading.
11. Spurious Cosmetic
A cosmetic shall be deemed to be spurious:
(i) if it is imported under a name which belongs to another cosmetic, or
(ii) if it is an imitation of or a substitute for another cosmetic; resembles another cosmetic
in a manner likely to deceive; or bears upon it or upon its label or container the name of
another cosmetic, or
(iii) if the label or container bears the name of an individual or a company purporting to
be the manufacturer of the cosmetic which individual or company is fictitious or does not
exist, or
(iv) if it purports to be the product of a manufacturer of whom it is not truly a product.

Schedules to the Act and Rules

There are two Schedules to the Act and 35 Schedules to the Rules.
The Schedules to the Act
1. First Schedule: It comprises the list of books of references for Ayurvedic, Siddha and
Unani medicines. There are 57 books of Ayurveda, 30 books of Siddha and 13 of Unani
Tibb systems listed in the Schedule which are used for different formulations in
accordance with the provisions of the Act.
2. Second Schedule: It comprises of the standards to be complied with for imported
drugs, manufacture of drugs, their sale, stocking and storage etc.
The Schedules to the Rules
Schedule A: Different Forms for application to procure licence, renewal of licence, and for
all other activities.

Schedule B: Rates of fees charged for analysis by COL or State Drugs Laboratories.

Schedule C: List of biological and other special products governed by special provisions

Schedule C (I): List of other special products governed by special provisions

Schedule D: Class of drugs: extent and conditions of exemption

Schedule D (I): Undertaking of the manufacturer or his authorized agent required to be

submitted along with application form for obtaining a registration certificate.

Schedule D (II): Undertaking of the manufacturer or his authorized agent required to be

submitted along with application form for registration of a bulk drug or its formulation or its
import into India

Schedule E (I): List of poisonous substance under Ayurvedic , Siddha and Unani medicines
Schedule F: Requirement for operation of blood bank and / or preparation of blood
components

Schedule F(I): Provisions for bacterial vaccines, viral vaccines, antisera, diagnostic
antigens, etc.

Schedule F (II): Standards for surgical dressings

Schedule F (III): Standards for Umbilical tapes

Schedule FF: Standards for ophthalmic preparations

Schedule G: Drugs required to be taken under medical supervision.

Schedule H: List of prescription drugs

Schedule J: List of diseases or ailments which a drug may not purport to prevent or cure.

Schedule K: Drugs exempted from certain provisions related to manufacturer.

Schedule M: GMP (Good Manufacturing Practices) comprising requirements of factory
premises, plant and equipment

Schedule M-l: Homoeopathic preparations requirements of factory premises, plants and

Equipments

Schedules M-(II): Cosmetics - requirements of factory premises for manufacture

Schedules M-(III): Requirements of factory premises for manufacture of medical devices

Schedule N: List of minimum equipment of running a pharmacy

Schedule O: Standards for disinfectant fluids

Schedule P: Life period of drugs

Schedule P-l: Pack sizes of drugs

Schedule Q: List of colors, dyes and pigments permitted in cosmetics and soaps, list of
colors permitted in soaps
Schedule R: Standards for condoms of rubber latex and other mechanical contraceptives

Schedule R-I: Standards for medical devices

Schedules S: Standards for Cosmetics

Schedules T: GMP (Good Manufacturing Practices) for manufacture of Ayurvedic, Siddha and
Unani medicines, G.M.P., machinery, equipment minimum manufacturing premises, etc.

Schedules U: Particulars required to be shown in manufacturing records; raw material and

analytical records

Schedules U (1): Particulars required to be shown in manufacturing records.

Schedules V: Standards for patent or proprietary medicines

Schedules X: Psychotropic substances

Schedules Y: Requirements and guidelines on clinical trials for import and manufacture of new
drug
Import of drugs and cosmetics

The import of drugs and cosmetics is regulated by the provisions of this Act.

Classes of drugs and cosmetics prohibited from import

The following categories of drugs and cosmetics are prohibited from import:
1. Drugs or cosmetics which are not of standard qualities.
2. Drugs or cosmetics which are misbranded, spurious and adulterated.
3. Drugs or cosmetics for import of which license is required.
4. Any patent or proprietary medicine without true formula or list of active ingredients
and their quantities.
5. Any drug or formulation which claims to prevent or cure diseases mentioned schedule
J.
6. Any drug or cosmetic for which manufacture, sale or distribution is prohibited in
country of its origin.
7. Any drug which is not packed or not labeled in conformity with the Rules of the Act.
8. Any cosmetic containing an ingredient which may render it unsafe or harmful.
9. Any drug or cosmetic the import of which is prohibited by Act.
Import under license or permit

The licensing authority grants a license for the import of following classes of drugs
A. Drugs specified in schedule C and C1 excluding those specified in schedule X
B. Drugs specified in schedule X
C. Small quantities of drugs imported for examination, test or analysis
D. Drugs for personal use prescribed by a Registered Medical Practitioner
E. Any new drug

A. Drugs specified in schedule C and C1 excluding those specified in schedule X

Conditions to be fulfilled:
1. Licensee must have adequate facilities for storage.
2. Licensee must maintain a record of the sale, showing the particulars of the names of
drugs and of the persons to whom they have been sold.
3. Licensee must allow an inspector to inspect premises and to check the records.
4. Licensee must furnish the sample to the authority.
5. Licensee must comply with undertaking given in the Form No:09.

B. Drugs specified in schedule X

Conditions to be fulfilled
1. A license is necessary.
2. Licensee must have adequate facilities for storage.
3. Applicant must be reputable in the occupation, trade or business.
C. Small quantities of drugs imported for examination, test or analysis
Conditions to be fulfilled
1. A license is necessary.
2. Imported under license in Form-11.
3. The licensee must use the imported drug only for the said purpose and use at the place
specified in the license.
4. The licensee must keep the record to the quantities, name of the manufacturer and date of import.

D. Drugs for personal use prescribed by a Registered Medical Practitioner

Conditions to be fulfilled
1. The drug must be bonified personal use.
2. The quantity should be reasonable and covered by RMP prescription.
3. The drug must be declared to the Custom Collector if so directed.
4. More than 100 doses are imported with license. Applying in Form No. 12A and 12B.

E. Any new drug

Conditions to be fulfilled
1. License is required.
2. The licensee is required to provide the documents of standards of quality, purity and
strength.
Offences and Penalties
The offences and penalties related to import of drugs is given in Table

Offences penalties

First Conviction Subsequent Conviction

1.An offence of an adulterated (section Imprisonment up Imprisonment up to 5

9-A) or spurious drug (section 9-B) or to three years and years or a fine up to ten
cosmetic (section 9-0) being imported a fine up to five thousand rupees or both.
into the country in violation of provisions thousand rupees.
of the Act

2. Import of drugs or ccosmetics other Imprisonment up Imprisonment up to 12

than those referred above the import of to 6 months or a months or a fine up to
which is forbidden. fine up to 500 1000 rupees or both.
rupees or both.

3. Any drug or cosmetic Imprisonment up Imprisonment up to 5

imported in contravention to three years years or a fine up to ten
with provisions of any or a fine up to five thousand rrupees or
notification issued under thousand both.
Section 10-A rupees or both.
Manufacture of Drugs

Manufacture in relation to any drug includes any process or part of a process for making, altering,
finishing, packing, labeling, breaking up or otherwise treating or adopting any drug with a view to its
sale and distribution, but does not include compounding or dispensing of any drug or packing of any
drug in ordinary course of retail business. Manufacture of drugs is a blend of art and science, to be
achieved strictly in accordance with the provisions of Good Manufacturing Practices (GMP).

Prohibition of manufacture and sale of certain drugs

The following categories of drugs and cosmetics are prohibited to be manufactured or sold in our
country.
1. Any drug or cosmetic which is substandard, misbranded, adulterated or spurious.
2. Any patent or proprietary medicine without clear indication of ingredients.
3. Any drug claiming for accurate cure or prevention of diseases listed in Schedule J.
4. Any manufacturing of formulation containing drug or cosmetic which has been imported
into our country in contravention to the provisions of the Act and Rules.
5. Manufacturing for sale of any drug or cosmetic containing any harmful ingredient.
6. Manufacturing for sale of any drug or cosmetic in contravention to the provisions of the
Act and Rules, provided that manufacture of small quantities of any drug for the purpose
of examination, test or analysis is permitted, subject to prescribed conditions. Separate
applications for separate licenses for more than one premises of manufacture are required
to be made.
Conditions for grant of license and conditions of license for manufacture of drugs

A person who is interested in starting manufacturing of drugs is required to fulfill several

conditions laid down in DCA and Rules. The conditions to be fulfilled before license is
granted are collectively called as "Conditions Precedent" and conditions that are required
to be fulfilled after the license is obtained for manufacturing are called "Conditions
Subsequent". The Licensing Authority is both in States and at Central Government. The
Central Government is empowered to prohibit manufacturing and sale of any drug
formulation in public interest.

The types of licenses are granted are

1. Manufacturing of drugs for examination, test or analysis
2. Manufacture of new drug
3. Manufacturing under Loan licenses
4. License for Repacking
5. License to Manufacture of drugs other than Schedule C, C(1), and Schedule X
6. License to Manufacture of Biological and Special Products in Schedules C and C (1)
7. Manufacturing of drugs belonging to Schedule X
Manufacture of drugs
Licenses are required for the manufacturing of following categories of drugs.
1. Manufacturing of drugs for examination, test or analysis
2. Manufacture of new drug
3. Manufacturing under Loan licenses
4. License for Repacking
5. License to Manufacture of drugs other than Schedule C, C(1), and Schedule X
6. License to Manufacture of Biological and Special Products in Schedules C and C (1)
7. Manufacturing of drugs belonging to Schedule X

1. Manufacturing of drugs for examination, test or analysis

If the manufacturer does not hold separate license for test, analysis or examination, the
license is obtained in Form 29. The provisions relating prohibition of manufacturing of
certain drugs do not apply for such manufacturing meant for test or analysis. The validity
of the license is for I year.
Conditions
1. The manufactured drugs should be kept in containers bearing appropriate label
indicating the purpose of test or analysis.
2. The drugs should be used for the purpose for which they are manufactured.
3. When the material is supplied to other manufacturer, the label stating the name
and address of manufacturer, scientific name of the drug, license number, date of
manufacture etc., should be provided.
4. The manufacturer should allow the Inspector to inspect the premises,
manufacturing, and analytical records and withdraw the samples if required for
analysis. The manufacturer should comply with the provisions of the Act and
Rules.
5. The manufacturer should maintain an Inspection Book and the same be shown
to the Inspector.
6. The licensee should comply with other requirements for which a notice has
been given to him one month before by the Licensing Authority.

2. Manufacture of new drug

In addition to provisions for manufacture of drugs, there should be documentary
evidence for quality, purity, therapeutic trials of new drugs and evidence for
approval under schedule 'Y‘ (Clinical trials).
3. Manufacturing under Loan licenses
Loan license is given to a person who does not have his own arrangements for
manufacturing but wishes to avail the manufacturing facilities owned by another licensee.
For drugs other than Schedules C, C(I) and X, loan licenses can be given. Drugs specified in
Schedules C/C(I),

Procedure
A license is obtained from licensing authority on application in prescribed form No. 24 A,
27 A with prescribed fees. Application for grant or renewal of loan license is made in Form
24 A. The license is issued by Licensing Authority in Form 25-A, which is valid for 1 year.

Conditions
1. The general conditions applicable to other than Schedules C, C(I) and X.
Additional conditions
1. Application must be supported by the parent firm.
2. Drug inspector inspects the premises of parent fi.rm and checks and assesses the spare
capacity.
3. Loan license is required to test each batch of raw materials and finished products.
4. Records of testing should be maintained for 5 years or 2 years in case of expiry drugs
from such data.
5. Patent medicines must be safe for use in the context of vehicle and additives
4. License for Repacking
Process of breaking up any drug from its bulk container [8] into small packages and labeling
with a view to their sale and distribution is done under repacking licence. It is issued for
drugs other than Schedules C, C1 and X, subject to fulfillment of conditions.
Procedure:
The application is made for grant or renewal of license in Form 24-B. The license is issued
by Licensing Authority after inspection in Form 25-B.
Conditions
1. Adequate space and equipment should be provided. Hygienic conditions of working
should always be maintained.
2. Repacking should be supervised by competent person.
3. There should be adequate arrangement for testing of samples.
4. The license should always be displaced at premises of repacking.
5. The factory premises for repacking should comply with provisions of Schedule M.
6. 6.Adequate staff should be appointed and any change in staff structure should be
immediately informed to Controlling Authority.
7. The container or package of repacked drug should bear on its label the words -
"Rpg.Lic.No".
8. The license is valid till31Ist December every year and required to be renewed. There
should be separate application for separate license.