Prof.Dr.VK Agarwal at 21:16, 25 March 2026

2026-03-25T21:16:09Z

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{{short description|Act of the Parliament of India}}
{{Use dmy dates|date=November 2018}}
{{Use Indian English|date=November 2018}}
{{Infobox legislation
| short_title = Drugs and Cosmetics Act, 1940
| image = Star of the Order of the Star of India (gold).svg
| imagesize = 200
| legislature = [[Imperial Legislative Council]]
| long_title = An Act to regulate the import, manufacture, distribution and sale of drugs and cosmetics.
| citation = [http://www.rajswasthya.nic.in/Drug%20Website%2021.01.11/12%20D%20&%20C%20Act%20amended%20upto%2026%20of%2008.pdf Act No. 23 of 1940]
| territorial_extent = [[India]]
| enacted_by = [[Imperial Legislative Council]]
| date_enacted =
| date_passed = 10 April 1940
| enacted_by2 =
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| amended_by = See [[Drugs and Cosmetics Act, 1940#Amendments|Amendments]]
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| status = In force
}}

The '''Drugs and Cosmetics Act, 1940''' is an [[act of the Parliament of India|act of the Imperial Legislative Council]] which regulates the import, manufacture and distribution of drugs in [[India]].<ref name="Kuchekar2008">{{cite book|author=Dr. B. S. Kuchekar|title=Pharmaceutical Jurisprudence|url=https://books.google.com/books?id=Fp-4VHZLl-4C&pg=SA5-PA1|access-date=26 December 2014|date=8 January 2008|publisher=Pragati Books Pvt. Ltd.|isbn=978-81-85790-28-2|pages=5.0–5.2}}</ref> 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.<ref name="Srivastava">{{cite book|author=Dr. Lily Srivastava|title=Law & Medicine|year=2010 |url=https://books.google.com/books?id=A5_TSdG13M4C&pg=PA216|publisher=Universal Law Publishing|isbn=978-81-7534-949-0|pages=216–}}</ref> 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.<ref name="Srivastava"/><ref name="Pillay2012">{{cite book|author=Pillay|title=Modern Medical Toxicology|url=https://books.google.com/books?id=MFcHBAAAQBAJ&pg=PA30|access-date=22 February 2015|date=30 November 2012|publisher=Jaypee Brothers Publishers|isbn=978-93-5025-965-8|page=30}}</ref>

==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.<ref name="Srivastava"/>

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.<ref name="Srivastava"/>

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.<ref name="Srivastava"/>

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.<ref name=fulltext>{{cite web|title=Drugs and Cosmetics Act, 1940|url=http://cdsco.nic.in/html/copy%20of%201.%20d&cact121.pdf|publisher=[[Central Drugs Standard Control Organization]]|access-date=19 February 2015|url-status=dead|archive-url=https://web.archive.org/web/20141226113109/http://cdsco.nic.in/html/copy%20of%201.%20d%26cact121.pdf|archive-date=26 December 2014}}</ref>

== 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.<ref name=US-NGO>{{cite news|title=Can't penalise US NGO for violating drug trial norms|url=http://indianexpress.com/article/india/india-others/cant-penalise-us-ngo-for-violating-drug-trial-norms/|access-date=18 August 2015|work=[[The Indian Express]]|date=18 April 2015}}</ref>

==Amendments==
The act has been amended several times. The following are a list of amending acts:<ref>{{Cite web |url=http://www.cdsco.nic.in/writereaddata/Drugs%26CosmeticAct.pdf |title=Archived copy |access-date=6 July 2022 |archive-date=20 September 2018 |archive-url=https://web.archive.org/web/20180920153748/http://www.cdsco.nic.in/writereaddata/Drugs%26CosmeticAct.pdf |url-status=dead }}</ref><ref>{{cite web|url=http://www.emergogroup.com/sites/default/files/file/india-drugs-and-cosmetics-act-1940-act-no-23.pdf|title=India Medical Device Regulations|date=16 October 2009|access-date=28 August 2016|archive-date=10 January 2017|archive-url=https://web.archive.org/web/20170110145941/http://www.emergogroup.com/sites/default/files/file/india-drugs-and-cosmetics-act-1940-act-no-23.pdf|url-status=dead}}</ref>

# The Drugs (Amendment) Act, 1960 (35 of 1960)
# The Drugs (Amendment) Act, 1962 (21 of 1962)
# The Drugs and Cosmetics (Amendment) Act, 1964 (13 of 1964)
# The Drugs and Cosmetics (Amendment) Act, 1972 (19 of 1972)
# The Drugs and Cosmetics (Amendment) Act, 1982 (68 of 1982)
# The Drugs and Cosmetics (Amendment) Act, 1986 (71 of 1986)
# The Drugs and Cosmetics (Amendment) Act, 1995 (71 of 1995)
# The Drugs and Cosmetics (Amendment) Act, 2008 (26 of 2008)<ref>{{Cite web |title=Wayback Machine |url=https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/DC_ACT_AMENDMENT_2008_file.pdf |archive-url=https://web.archive.org/web/20221003040739/https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/DC_ACT_AMENDMENT_2008_file.pdf |archive-date=2022-10-03 |access-date=2025-10-26 |website=cdsco.gov.in}}</ref>

==See also==
* [[Drug policy of India]]
* [[Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954]]

==References==
{{reflist}}

== Bibliography ==
* {{cite book|title=Law Relating to Drugs and Cosmetics|first=Vijay|last=Malik|year=2014|edition= 24th |publisher=Eastern Book Company|place=Lucknow|isbn= 978-93-5145-313-0 }}
* {{cite book|title=Supreme Court on Narcotics and Drugs|first=Surendra|last=Malik|year=2016|edition=2nd|publisher=Eastern Book Company|place=Lucknow|isbn= 978-93-5145-318-5}}
* {{cite book|title=Supreme Court on Drugs, Medical Laws and Medical Negligence |first=Surendra|last=Malik|year=2014|edition=1st|publisher=Eastern Book Company|place=Lucknow|isbn= 978-93-5028-850-4}}

==Further reading==
* {{cite web|title=Drugs and Cosmetics Act, 1940|url=http://cdsco.nic.in/html/copy%20of%201.%20d&cact121.pdf|publisher=[[Central Drugs Standard Control Organization]]|url-status=dead|archive-url=https://web.archive.org/web/20141226113109/http://cdsco.nic.in/html/copy%20of%201.%20d%26cact121.pdf|archive-date=2014-12-26}}

[[Category:1940 in Indian law]]
[[Category:Cosmetics law]]
[[Category:Drug control law in India]]
[[Category:Acts of the Imperial Legislative Council]]

Drugs and Cosmetics Act 1940 - Revision history

Prof.Dr.VK Agarwal at 21:16, 25 March 2026