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ARTICLE · 18 MARCH 2015

Pharma Hotline - March 09, 2015

Nishith Desai Associates
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India's Health Ministry has released a draft of the proposed amendments to the Drugs and Cosmetics Act 1940 (Act) for public consultation.

IndiaIntellectual Property
Anay Shukla
Anay Shukla
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PROPOSED OVERHAUL OF DRUG REGULATORY SYSTEM (INDIA)

India's Health Ministry has released a draft of the proposed amendments to the Drugs and Cosmetics Act 1940 (Act) for public consultation. The Act is the primary legislative instrument which lays down the regulatory framework for drugs that are manufactured or imported for marketing in India.

The draft proposes to vest the powers to approve the manufacture of certain drugs in India exclusively with a single central authority appointed by the Health Ministry of the Union Government. Until now, the approval powers were vested with authorities appointed by the respective State Governments. The drugs sought to be centrally regulated include drug products comprising fixed dose combinations, monoclonal antibodies, stem cells, gene therapeutic products and xenografts.

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