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{{Use Indian English|date=November 2018}} | {{Use Indian English|date=November 2018}} | ||
{{Infobox legislation | {{Infobox legislation | ||
|short_title | | short_title = Drugs and Cosmetics Act, 1940 | ||
| | | image = Star of the Order of the Star of India (gold).svg | ||
| imagesize = 200 | |||
|imagesize | | 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] | |||
|long_title | | territorial_extent = [[India]] | ||
|citation | | enacted_by = [[Imperial Legislative Council]] | ||
|territorial_extent | | date_enacted = | ||
|enacted_by | | date_passed = 10 April 1940 | ||
|date_enacted | | enacted_by2 = | ||
|date_passed | | date_enacted2 = | ||
|enacted_by2 | | date_passed2 = | ||
|date_enacted2 | | date_assented = | ||
|date_passed2 | | signed_by = | ||
|date_assented | | date_commenced = | ||
|signed_by | | date_repealed = | ||
|date_commenced | | administered_by = | ||
|date_repealed | | bill = | ||
|administered_by | | bill_citation = | ||
|bill | | bill_date = | ||
|bill_citation | | introduced_by = | ||
|bill_date | | 1st_reading = | ||
|introduced_by | | 2nd_reading = | ||
|1st_reading | | 3rd_reading = | ||
|2nd_reading | | conf_committee_passed = | ||
|3rd_reading | | committee_report = | ||
|conf_committee_passed | | bill2 = | ||
|committee_report | | bill_citation2 = | ||
|bill2 | | bill_date2 = | ||
|bill_citation2 | | introduced_by2 = | ||
|bill_date2 | | 1st_reading2 = | ||
|introduced_by2 | | 2nd_reading2 = | ||
|1st_reading2 | | 3rd_reading2 = | ||
|2nd_reading2 | | conf_committee_passed2 = | ||
|3rd_reading2 | | committee_report2 = | ||
|conf_committee_passed2 = | | date_conf_committee = | ||
|committee_report2 | | white_paper = | ||
|date_conf_committee | | amended_by = See [[Drugs and Cosmetics Act, 1940#Amendments|Amendments]] | ||
|white_paper | | repeals = | ||
| | | related_legislation = | ||
|repeals | | summary = | ||
|related_legislation | | keywords = | ||
|summary | | status = In force | ||
|keywords | |||
|status | |||
}} | }} | ||
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]].<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|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]] | 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== | ==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"/> | 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 | 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 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 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> | 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== | == 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= | 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== | ==Amendments== | ||
The act has been amended several times. The following are a list of amending acts:<ref>http://www.cdsco.nic.in/writereaddata/Drugs | 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, 1960 (35 of 1960) | ||
| Line 73: | Line 71: | ||
# The Drugs and Cosmetics (Amendment) Act, 1972 (19 of 1972) | # 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, 1982 (68 of 1982) | ||
# The Drugs and Cosmetics (Amendment) Act, 1986 | # 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, 1995 (71 of 1995) | ||
# The Drugs and Cosmetics (Amendment) Act, 2008 (26 of 2008)<ref>https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/DC_ACT_AMENDMENT_2008_file.pdf | # 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== | ==See also== | ||
| Line 82: | Line 80: | ||
==References== | ==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=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 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}} | * {{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== | ==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}} | * {{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 | [[Category:1940 in Indian law]] | ||
[[Category: | [[Category:Cosmetics law]] | ||
[[Category:Drug control law in India]] | [[Category:Drug control law in India]] | ||
[[Category:Acts of the | [[Category:Acts of the Imperial Legislative Council]] | ||
Latest revision as of 02:46, 26 March 2026
| Drugs and Cosmetics Act, 1940 | |
|---|---|
.svg) | |
| Imperial Legislative Council | |
| |
| Citation | Act No. 23 of 1940 |
| Territorial extent | India |
| Enacted by | Imperial Legislative Council |
| Passed | 10 April 1940 |
| Amended by | |
| See Amendments | |
| Status: In force | |
The Drugs and Cosmetics Act, 1940 is an act of the Imperial Legislative Council 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]
Summary[edit | edit source]
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[edit | edit source]
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[edit | edit source]
The act has been amended several times. The following are a list of amending acts:[6][7]
- 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)[8]
See also[edit | edit source]
References[edit | edit source]
- ↑ 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.
- ↑ 2.0 2.1 2.2 2.3 2.4 Dr. Lily Srivastava (2010). Law & Medicine. Universal Law Publishing. pp. 216–. ISBN 978-81-7534-949-0.
- ↑ Pillay (30 November 2012). Modern Medical Toxicology. Jaypee Brothers Publishers. p. 30. ISBN 978-93-5025-965-8. Retrieved 22 February 2015.
- ↑ "Drugs and Cosmetics Act, 1940" (PDF). Central Drugs Standard Control Organization. Archived from the original (PDF) on 26 December 2014. Retrieved 19 February 2015.
- ↑ "Can't penalise US NGO for violating drug trial norms". The Indian Express. 18 April 2015. Retrieved 18 August 2015.
- ↑ "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) - ↑ "India Medical Device Regulations" (PDF). 16 October 2009. Archived from the original (PDF) on 10 January 2017. Retrieved 28 August 2016.
- ↑ "Wayback Machine" (PDF). cdsco.gov.in. Archived from the original (PDF) on 3 October 2022. Retrieved 26 October 2025.
{{cite web}}: Cite uses generic title (help)
Bibliography[edit | edit source]
- 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[edit | edit source]
- "Drugs and Cosmetics Act, 1940" (PDF). Central Drugs Standard Control Organization. Archived from the original (PDF) on 26 December 2014.