Medical devices now under Drugs and Cosmetics Act

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News: Ministry of health and family welfare said in a notification, that from 1st April 2020, all medical devices sold in the country would be treated as drugs and would be regulated under the Drugs and Cosmetics Act of 1940. The decision was taken after consultation with the Drugs Technical Advisory Board (DTAB)

Facts:

Significance:

  • Regulation of prices under the Drugs Price Control Order (DPCO)
  • Companies have to seek approval from the drug controller to manufacture, import and sell any medical device in the country.

Additional Information:

Drugs Technical Advisory Board

  • It is highest statutory decision-making body on technical matters related to drugs in the country. It was constituted as per the Drugs and Cosmetics Act, 1940.
  • It is part of Central Drugs Standard Control Organization (CDSCO) in the Ministry of Health and Family Welfare.

Central Drugs Standard Control Organization (CDSCO):

  • It is the national regulatory body for Indian pharmaceuticals and medical device. Currently, the government regulates 37 notified medical devices under the law.
  • It functions under the Drugs and Cosmetics Act, 1940. CDSCO comes under Directorate General of Health Services, Ministry of Health & Family Welfare.

 The Drugs and Cosmetics Act, 1940:

  • It regulates the import, manufacture, and distribution of drugs in India. 
  • 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