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 India, officially the Republic of India, is a country in South Asia. It is the List of countries and dependencies by area, seventh-largest country by area; the List of countries by population (United Nations), most populous country since ...

. 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. 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.

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. 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 Ayurveda (; ) is an alternative medicine system with historical roots in the Indian subcontinent. It is heavily practised throughout India and Nepal, where as much as 80% of the population report using ayurveda. The theory and practice of ayur ...

and

Unani Unani or Yunani medicine (Urdu: ''tibb yūnānī'') is Perso-Arabic traditional medicine as practiced in Muslim culture in South Asia and modern day Central Asia. Unani medicine is pseudoscientific. The term '' Yūnānī'' means 'Greek', ref ...

drugs. 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. 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.

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 The Gates Foundation is an American private foundation founded by Bill Gates and Melinda French Gates. Based in Seattle, Washington, it was launched in 2000 and is reported to be List of wealthiest charitable foundations, the third largest char ...

-funded Programme for Appropriate Technology in Health (PATH) for violating norms in conducting the

HPV Human papillomavirus infection (HPV infection) is caused by a DNA virus from the ''Papillomaviridae'' family. Many HPV infections cause no symptoms and 90% resolve spontaneously within two years. In some cases, an HPV infection persists and ...

vaccination trials on tribal girls in

Andhra Pradesh Andhra Pradesh (ISO 15919, ISO: , , AP) is a States and union territories of India, state on the East Coast of India, east coast of southern India. It is the List of states and union territories of India by area, seventh-largest state and th ...

and

Gujarat Gujarat () is a States of India, state along the Western India, western coast of India. Its coastline of about is the longest in the country, most of which lies on the Kathiawar peninsula. Gujarat is the List of states and union territories ...

. On 17 April 2015, the government told the

Supreme Court of India The Supreme Court of India is the supreme judiciary of India, judicial authority and the supreme court, highest court of the Republic of India. It is the final Appellate court, court of appeal for all civil and criminal cases in India. It also ...

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.

Amendments

The act has been amended several times. The following are a list of amending acts: # 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 # The Drugs and Cosmetics (Amendment) Act, 1995 (71 of 1995) # The Drugs and Cosmetics (Amendment) Act, 2008 (26 of 2008)https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/DC_ACT_AMENDMENT_2008_file.pdf

References

Bibliography

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Summary

Controversy

Amendments

See also

References

Bibliography

Further reading