Drugs and Cosmetics Act, 1940

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.^[1] The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.^[2] The related Drugs and Cosmetics Rules, 1945 contain provisions for classification of drugs under given schedules and provide guidelines for the storage, sale, display and prescription of each schedule.^[2][3]

The Drugs and Cosmetics Act, 1940
Parliament of India
Long title An Act to regulate the import, manufacture, distribution and sale of drugs and cosmetics.
Citation	Act No. 23 of 1940
Territorial extent	India
Passed	10 April 1940
Amended by
See Amendments
Status: In force

Summary

This act was originally known as the Drug Act and was passed in 1940. The original act was prepared in accordance to the recommendations of the Chopra Committee formed in 1930. 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.^[2]

The term "drug" as defined in the act, includes various substances, 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. In 1964, the act was amended to include Ayurveda and Unani drugs.^[2]

The Section 16 of the act defines the standards of quality for drugs. The Section 17 defines "misbranding". A drug is considered misbranded if it claims to be of more therapeutic value than it actually is. The manufacturer of such a drug may be asked to suspend the manufacture of the drug under Section 18. Section 27 deals with fake and adulterated drugs. The act requires more of that ingredients of the drugs should be printed on the label.^[2]

The Section 22 defines the powers of the drug inspectors and Section 23 defines the strict procedure which should be followed by the inspectors during any raids.^[4]

Controversy

The act lacks specific penalties for violating provisions relating to clinical trials. As a result, 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.^[5]

Amendments

The act has been amended several times. The following are a list of amending acts:^[6][7]

1. The Drugs (Amendment) Act, 1960 (35 of 1960)
2. The Drugs (Amendment) Act, 1962 (21 of 1962)
3. The Drugs and Cosmetics (Amendment) Act, 1964 (13 of 1964)
4. The Drugs and Cosmetics (Amendment) Act, 1972 (19 of 1972)
5. The Drugs and Cosmetics (Amendment) Act, 1982 (68 of 1982)
6. The Drugs and Cosmetics (Amendment) Act, 1986
7. The Drugs and Cosmetics (Amendment) Act, 1995 (71 of 1995)
8. The Drugs and Cosmetics (Amendment) Act, 2008 (26 of 2008)^[8]

See also

• Drug policy of India
• Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954

References

1. Dr. B. S. Kuchekar (8 January 2008). Pharmaceutical Jurisprudence. Pragati Books Pvt. Ltd. pp. 5.0–5.2. ISBN 978-81-85790-28-2. Retrieved 26 December 2014.
2. Dr. Lily Srivastava (2010). Law & Medicine. Universal Law Publishing. pp. 216–. ISBN 978-81-7534-949-0.
3. Pillay (30 November 2012). Modern Medical Toxicology. Jaypee Brothers Publishers. p. 30. ISBN 978-93-5025-965-8. Retrieved 22 February 2015.
4. "Drugs and Cosmetics Act, 1940" (PDF). Central Drugs Standard Control Organization. Archived from the original (PDF) on 26 December 2014. Retrieved 19 February 2015.
5. "Can't penalise US NGO for violating drug trial norms". The Indian Express. 18 April 2015. Retrieved 18 August 2015.
6. "Archived copy" (PDF). Archived from the original (PDF) on 20 September 2018. Retrieved 6 July 2022.{{cite web}}: CS1 maint: archived copy as title (link)
7. "India Medical Device Regulations" (PDF). 16 October 2009.
8. https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/DC_ACT_AMENDMENT_2008_file.pdf ^{[bare URL PDF]}

Bibliography

• Malik, Vijay (2014). Law Relating to Drugs and Cosmetics (24th ed.). Lucknow: Eastern Book Company. ISBN 978-93-5145-313-0.
• Malik, Surendra (2016). Supreme Court on Narcotics and Drugs (2nd ed.). Lucknow: Eastern Book Company. ISBN 978-93-5145-318-5.
• Malik, Surendra (2014). Supreme Court on Drugs, Medical Laws and Medical Negligence (1st ed.). Lucknow: Eastern Book Company. ISBN 978-93-5028-850-4.

Further reading

• "Drugs and Cosmetics Act, 1940" (PDF). Central Drugs Standard Control Organization. Archived from the original (PDF) on 26 December 2014.