Legislation has been introduced in India that would establish a new Central Drugs Authority (CDA) with overarching power to regulated drugs, devices and cosmetics.

The Drugs and Cosmetics (Amendment) Bill of 2013 was introduced on 30 August 2013 in the Rajya Sabha (Upper House of Indian Parliament) by Health and Family Welfare Minister Ghulam Nabi Azad and would replace the Drugs and Cosmetics Act of 1940.

The Central Drugs Authority would be composed of 19 members, headed by the Secretary of the Ministry of Health and Family Welfare (MHFW). It would establish regulations and norms for effective functioning of central and state drug licensing authorities and periodically assess their functioning. It would also have the authority to review, suspend or cancel any permission or license for drugs and cosmetics manufacturing.

The bill establishes centralized licensing for 17 categories of critical drugs, and includes separate chapters with regulatory frameworks governing medical devices, product exports and clinical trials, including provision for compensation for deaths or injury of a trial subjects. Penalties for violations are also set forth in the bill.

 

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