Amendments of Drugs and Cosmetic Act –

The Drugs and Cosmetic Act which has 38 Sections originally passed by the Indian Legislature
with the approval of Governor General on 10th April of 1940, whose main purpose was to
regulates the import, manufacture and distribution of drugs in India, so that the drugs and
cosmetic which is sold in the market is of good quality and is not harmful to the people who are
in use of it. But the Rules regarding the Drugs and Cosmetic came into force in 1945 as the
Drugs and Cosmetic Rule, this rule contains provisions for classification of drugs under given
schedules and there are guidelines for the storage, sale, display and prescription of each
schedule.

The term "drug" as defined in the act includes a wide variety of substance, diagnostic and
medical devices. The act defines "cosmetic" as any product that is meant to be applied to the
human body for the purpose of beautifying or cleansing. The definition however excludes soaps.

This original act was passed on the recommendation of Chopra Committee which was formed in
1930, and their related rules was passed in 1945. Since this act came into existence i.e in 1940, it
has undergone many amendments and many were repealed with the passage of time.

Amendments to the Drugs and Cosmetic Act –

In shaping the laws related to the Drugs and cosmetic in India, it was mainly come into shape by
the Recommendation made by the Committees formed time in again to change with the changing
time as Law commission Report or by passing of a Bill by both the house and with the consent of
the President; like, earlier there was punishment for Adulterated Drugs only and not the
Adulterated Cosmetics but with the Amendment, new law was also passed regarding the
Adulterated Cosmetics also. Amendments to it has also taken into shape by different judgments
taken place time and again like the cases of

Cadila Health Care Ltd. Vs. Cadila Pharmaceutical Ltd., 2001 Supreme Court

Pratap Pharma (Pvt.) Ltd. and Another Etc. Etc. Vs. Union of India, 1997 SC

On that basis Amendments were made by the Legislative and the Judiciary as accordance as the
country needed –

The Drugs Amendment Act , 1955—

As Amended by Act no. 11 of 1955

This Amendment Act was repealed by Act 58 of 1960 with enforcement from 26 Jan of 1960.

By this Amendment new clause (bbb) was added in Section 3 as 'manufacture' in relation to any
drug includes any process or part of a process for making, altering, orna- menting, finishing,
packing, labelling, breaking up or other- wise treating or adopting any drug with a view to its

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sale and distribution but does not include the compounding or dispensing or the packing of any
drug in the ordinary course of retail business; and 'to manufacture' shall be construed
accordingly.

The Drugs Amendments Act, 1960 -

As Amended by Act No. 35 of 1960

[PASSED BY THE INDIAN PARLIAMENT]

(Received the assent of the President on the 15th September, 1960)

This section was further repealed by Act no. 54 of 1964 w.e.f. 29 December 1964

The Drugs Amendments Act, 1962 -

As Amended by Act No. 21 of 1962

[PASSED BY THE INDIAN PARLIAMENT]

(Received the assent of the President on the 27th June, 1962)

The Drugs and Cosmetic Amendment Act, 1964 -

As Amended by Act No. 13 of 1964

[PASSED BY THE INDIAN PARLIAMENT]

(Received the assent of the President on the 12th May, 1964)

Amendment in Section 3 – In clause (a) of it includes Ayurvedic and Unani drugs also as- '(a)
"Ayurvedic (including Siddha) or Unani drug" includes all medicines intended for internal or
external use for or in the diagnosis, treatment, mitigation or prevention of disease in human
beings, mentioned in, and processed and manufactured exclusively in accord- ance with the
formulae described in, the authoritative books of Ayurvedic (including Siddha) and Unani (Tibb)
systems of medicine, specified in the First Schedule.

New section was inserted as 7A by this Amendment.

In section 8 of Principle act, the word “the schedule” substituated as ‘second schedule’.

Section 9B, 17B, 18A, 31A, 32A, 33A, 34A – These section is inserted by this Amendment.

The Drug and Cosmetic Amendment Act, 1972 –

As Amended by Act No.19 of 1972

[PASSED BY THE INDIAN PARLIAMENT]

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(Received the assent of the President on the 31st May, 1972)

The Drugs and Cosmetic Amendment Act, 1982 –

As Amended by Act No.68 of 1982

[PASSED BY THE INDIAN PARLIAMENT]

(Received the assent of the President on the 13th November, 1982)

The Drugs and Cosmetic Amendment Act, 1986 –

As Amended by Act No. 71 of 1986

[PASSED BY THE INDIAN PARLIAMENT]

(Received the assent of the President on the 24th December, 1986)

The Drugs and Cosmetic Amendments Act, 1995 –

As Amended by Act 22 of 1995.

[PASSED BY THE INDIAN PARLIAMENT]

(Received the assent of the President of India)

RECOMMENDATION—

1)Use of Generic medicine should be increased over Branded Medicine-

As Generic Medicines are cheaper than that of the Branded Medicines and provide the same
medical benefit as that of the branded medicine provides. A generic medicine is as identical in
dose, strength, safety, efficiency and intended use and are cheaper than that of the equivalent
brand because of its much lower marketing cost and are the identical products with the same
content and therapeutic action.

Some People have the myth in their mind that the Generic medicine are less effective or with the
side effects rather than in the case of Branded Medicine but it is totally wrong and is based on
the misconception and to prove the same, a study was conducted and it proves that due of
Generic medicine till now there has been not a single case of Death and Grievous hurt occurred
in any part of the world.

2)Unfair and unethical way of practicing of selling of Drugs should be made a cognizable
offence under The Drugs and Cosmetic Act, 1945.

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3) The Act lacks specific penalties for violating provisions relating to clinical trials – As far as
the Law is concerned, there has been no Punishment for the Companies who is testing/ sampling
their product on human being and due to which Drug companies are experimenting their product
on the people which sometimes leads to Death as Side infaction.

4) There is a dire need of making of a strict rule on use of drugs for animals under Drugs and
Cosmetics Act, as it is not strict enough as compare to the act for the human being.

5) To control the Fake Drugs – Indians Drugs and Controller General’s reports of Chinese fake
drugs with 'Made in India' labels or certain African countries faking Indian medicines as 'Made
in India' show that the spurious drugs supposed to be of Indian origin are not made in India
locally." As there is a strict need of law to be made for the same.

CASE ANALYSIS –

1)

Case Title -- Rajiv Kumar v. State of Punjab

Citation— 1998 CriLJ 1460

Bench – M Singhal

Facts of the Case – Petition was filed by Rajiv Kumar under Section 22 of Drugs and Cosmetic
Act.  It has been stated by him that he is the holder of a medical store named asM/s. R. K.
Medical Store, New Dana Mandi, Sirhind for carrying on the business of wholesale Chemists
under a valid drugs licence which authorizes him to sell, stock or exhibit (or offer) for sale or
distribute by retail the categories of Drugs specified in Schedule C and C (I) excluding those
specified in Schedule X to the Drugs and Cosmetics Rules, 1945 and to operate pharmacy on the
premises situated at G.T. Road, Bye-pass, Sirhind Mandi, District Fatehgarh Sahib. According to
the prosecution, on 18-7-1996 Inspector Harbhajan Singh along with Sh. M. L. Gupta, Drugs
Inspector, Fatehgarh Sahib and others raided his medical shop and ceased many medicines/drugs.

Prosecution’s Contention – As the possession of the drugs which are being seized are in the
prohibited degree of both Drugs and Cosmetic Act and NDPS Act under section 22.

Contention of Respondent – He claims that all the Drugs which are being seized fall within the
Drugs and Cosmetics Act and not in the Narcotics and Drugs Act, and under Drugs and
Cosmetic Act, he is licensed to sell these medicines

Judgment - Court came to the conclusion that the claims and the seizer made by the Inspector
was not according to the NDPS Act and the the shop owner was in the prohibited degree of
Drugs and Cosmetic Act.

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The appeal was disposed

2)

Case Title - Union Of India & Anr vs M/S Swiss Garnier Life Sciences

Citation of Case - APPEAL NO. 5117 OF 2012 (ARISING OUT OF SLP(C) NO.11107 OF
2012)

Case Held – Supreme Court of India

Bench -  G.S. Singhvi, Sudhansu Jyoti Mukhopadhaya

Facts of the Case—

Apellant on the basis of the a editorial which was published in ‘The Hindu’ on 14 thMay, 2008
which says that the sale of ‘Doxofylline formulations’ as a part of tactics to replace less
profitable price controlled products i.e. ‘Theophylline’ with huge profitable alternatives of the
same class. On the basis of it, the appellant asked the reason  as why ‘Doxofylline’ should be
classified as derivative of Theophylline to all the manufactures, and due to which matter become
widespread and a committee was set up for the same to know as it is right or wrong to Indian
Institute of Science, Banglore and based on its advice as to fix the price of ‘Doxofylline
formulations’.

Judgement –

The following advice was taken into consideration and the new terms were added to the Second
Schedule of the Drugs and Cosmetic act. It was held that Doxofylline is a derivative of
Theophylline and was added in Para 2(a) of Bulk Drugs of Drugs and Cosmetic Act, 1940.

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3)Case Title - Sk. Amir vs The State Of Maharashtra

Citation - 1974 AIR 469, 1974 SCR (3) 84

Court – Supreme Court of India

Bench - Chandrachud, Y.V.

Act – Drugs and Cosmetics Act (23 of 1940)--Ss.18 and 27— meaning and scope of 'Stocked
for sale'.

Facts of the Case—

Appellant Sk. Amir has obtained a parcel from the railway authorities, there he was apprehended
by a railway constable at the gate of the Malkapur railway station. The parcel was found to
contain 95,000 capsules of Seco Barbital Sodium which is a sedative agent and is commonly
used for intoxication and popularly called "Lal pari".  The appellant admitted that he was
carrying the parcel at the time of his arrest but his contested that he took delivery of the parcel on
behalf of one Mohamod Jamadar who had represented to him that the parcel contained a 'science
apparatus' meant for a school.

Charges Framed – Charged with the offence of stocking for sale a misbranded drug without a
licence under S. 18(a) (ii) and s.18(c) read with S. 27(a) (ii) and 27(b) of the Drugs and
Cosmetics Act, 1940

Judgment — Trial court convict him. The District Judge on appeal, acquitted the appellant. The
High Court on further appeal sentenced the appellant to a minimum Sentence of one year's
imprisonment prescribed by the Act. Supreme Court held that the merely found of drugs with
the person is not enough to establish that the appellant had stocked the drug. The large quantity
of 95,000 capsules found in the possession of the appellant leaves no doubt that he had stocked
or kept the drug for sale. it could not have been meant for his personal use and his defence that
he had received the parcel on behalf of another person, not knowing what it contained, was
rightly rejected by all the three courts.

Reasoning of Judgment – If one keeps or carries a drug on his person in contravention of the
terms of the Act and it is proved that the drug is kept or carried for sale, the act must fall within
the mischief of the law. In the instant case a large quantity of capsules found in the possession of
the appellant leaves no doubt that he had stocked or kept the drug for sale.

Comment – The question which was in front of S.C. was that the word ‘ stock’ in the act is ‘to
keep’ in possession and the ‘injunction of law’ under this act means no person shall keep for
sale a misbranded drug or a drug in respect of which a valid licence is not held.

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1)An Analysis of the Regulation of Food,Drugs and Cosmeticst – Maurice L. Cowen

Citation: Maurice L. Cowen, Analysis of the Regulation of Food,

Drugs and Cosmetics , 42 Ill. L. Rev. 169 (1947-1948)

This article speaks about how the legislation evolved and what was the need of it and
what the difficulties were before the making of a act for all the commodities. At that time
the use of cosmetics was gaining wide proportions and resulting in socially distasteful
effects. It was suggested that the use of cosmetics be regulated by providing that
allwomen, regardless of their age or social status, and as there was no law at the time
which can regulate the market, so due to which in 1770 the legislation was laid.

2) BEYOND THE FOOD WE EAT:ANIMAL DRUGS IN LIVESTOCK

PRODUCTION -SUSAN A. SCHNEIDER
Citation - Susan A. Schneider, Beyond the Food We Eat: Animal Drugs in Livestock
Production, 25 Duke Envtl. L. & Pol'y F. 227 (2015)

A number of questions has raised as the use of drugs for the animals, including the
presence of drug residues in meat and the impact of these production techniques on
animal welfare, which indirectly effect the human beings. This article, focuses
particularly on an issue that has not received attention-the potential environmental impact
associated with this use of pharmaceuticals. It is also one of the recommendation which
Drugs and Cosmetic Act, 1940 should include, as there is no law for the same.
This article also emphasize as how the industry has changed in the last several decades,
noting the intensification of individual production facilities and the concentration of the
industry in certain regions.

3)Drugs and Cosmetic Act, 1940 (As amended up to the 31st December, 2016)

This act came into existence in 1940 on the recommendation of Chopra Committee and
amended many times and includes 38 Sections for now.

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