The Drugs and Cosmetics Act, 1940 is an

act of the Parliament of India This is a chronological, but incomplete list of Acts passed by the Imperial Legislative Council between 1861 and 1947, the Constituent Assembly of India between 1947 and 1949, The Provisional Parliament between 1949 and 1952, and the Parliament ...

which regulates the import, manufacture and distribution of drugs in

India India, officially the Republic of India (Hindi: ), is a country in South Asia. It is the seventh-largest country by area, the second-most populous country, and the most populous democracy in the world. Bounded by the Indian Ocean on the so ...

. 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 The ''Drugs and Cosmetics Rules, 1940'' are the rules which the government of India established through the Drugs and Cosmetics Act, 1940. These rules classify drugs under given schedules and present guidelines for the storage, sale, display an ...

contains provisions for classification of drugs under given schedules and there are 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 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 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. The theory and practice of Ayurveda is pseudoscientific. Ayurveda is heavily practiced in India and Nepal, where around 80% of the population repo ...

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 Indian Medical Association describes U ...

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 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 Bill & Melinda Gates Foundation (BMGF), a merging of the William H. Gates Foundation and the Gates Learning Foundation, is an American private foundation founded by Bill Gates and Melinda French Gates. Based in Seattle, Washington, it was ...

-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 re ...

vaccination trials on tribal girls in

Andhra Pradesh Andhra Pradesh (, abbr. AP) is a state in the south-eastern coastal region of India. It is the seventh-largest state by area covering an area of and tenth-most populous state with 49,386,799 inhabitants. It is bordered by Telangana to the ...

and

Gujarat Gujarat (, ) is a state along the 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 fifth-largest Indian state by area, covering some ; and the ninth ...

. On 17 April 2015, the government told the

Supreme Court of India The Supreme Court of India ( IAST: ) is the supreme judicial authority of India and is the highest court of the Republic of India under the constitution. It is the most senior constitutional court, has the final decision in all legal matters ...

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