The document summarizes the Drugs and Cosmetics Act of 1940 in India. It regulates the import, manufacture, and distribution of drugs and cosmetics. The Act aims to ensure drugs and cosmetics are produced and sold by licensed and qualified persons. It also aims to prevent substandard drugs. The Act has faced several amendments over time and some controversy over its lack of penalties for violations of clinical trial provisions.

1. DRUGS AND COSMETICS ACT,
1940

2. CONTENT
 Introduction
 Meaning
 Objectives
 Controversy
 Amendments
 Case Laws
 Conclusion
 Bibliography

3. INTRODUCTION
 The Drugs and Cosmetics Act, 1940 is
an Act of the Parliament of India which
regulates the import, manufacture and
distribution of drugs in India.
 This act was originally known as the Drug
Act and was passed in 1940.
 The related Drugs Rules was passed in
1945. Since 1940, the act has undergone
several amendments and is now known as
the Drugs and Cosmetics Act, 1940.

4. MEANING
 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 act defines "cosmetic" as any product
that is meant to be applied to the human
body for the purpose of beautifying or
cleansing.

5. OBJECTIVES
 To regulate the import, manufacture,
distribution and sale of drugs &
cosmetics through licensing.
 Manufacture, distribution and sale of
drugs and cosmetics by qualified
persons only.
 To prevent substandard in drugs.
 To regulate the manufacture and sale of
Ayurvedic, Siddha and Unani drugs.

6. CONTROVERSY
 The Act lacks specific penalties for violating
provisions relating to clinical trials.
 No penalties could be imposed on the Bill and
Melinda Gates Foundation-funded Programme for
Appropriate Technology in Health (PATH) for
violating norms in conducting the HPV vaccination
trials on tribal girls in Andhra Pradesh and Gujarat.
 On 17 April 2015, the government told the Supreme
Court of India that due to lack of specific penalties,
the government could only halt the trials and issued
warnings.
 The trial had been found to be unethical by a
Parliamentary committee in 2013.

7. AMENDMENTS
 The Drugs (Amendment) Act, 1955 (11 of 1955).
 The Drugs (Amendment) Act, 1960 (35 of 1960).
 The Drugs (Amendment) Act, 1962 (21 of 1962).
 The Drugs and Cosmetics (Amendment) Act, 1964
(13 0f 1964).
 The Drugs and Cosmetics (Amendment) Act, 1955
19 of 1972).
 The Drugs and Cosmetics (Amendment) Act, 1982
(68 of 1982).
 The Drugs and Cosmetics (Amendment) Act, 1986
 The Drugs and Cosmetics (Amendment) Act, 1995
(71 of 1995).

8. CASE LAWS
 Subhash Chand vs State(Delhi
Administration) on 8 January, 2013
 Gyan Prakash vs The State Of Bihar
& Ors on 24 July, 2014
 U.O.I. & Anr vs Sajeev V. Deshphande
on 12 August, 2014
 Anil Kumar Agrawal vs The State Of
Bihar on 29 April, 2014

9. CONCLUSION
 The Drugs and Cosmetics Act, 1940 is a
consumer protection legislation.
 The 1986 amendment conferred powers on
recognised Consumer Associations so that
legal action can be initiated by them in the
court on the basis of test reports given by
the Government Analyst.
 The standard and purity of manufactured
drugs are very important and therefore
rules need to be amended to safeguard the
interest of the consumers.

10. BIBLIOGRAPHY
 Law & Medicine – Dr. Nandita Adhikari
 Indian kanoon

11. THANK
YOU!!!