10 November 2017Asia

LSIPR 50 2017: Gyanendra Nath Singh and Krishnaswamy VijayRaghavan

Names: Gyanendra Nath Singh and Krishnaswamy VijayRaghavan

Organisation: Indian government

Positions: Drugs controller general, and secretary of the Department of Biotechnology

Gyanendra Nath Singh, head of India’s Central Drugs Standard Control Organization, and Krishnaswamy VijayRaghavan, secretary of the Department of Biotechnology, have been nominated this year to LSIPR 50 for their organisations’ contribution to the changes of guidelines for approving biosimilar products.

The “Guidelines on Similar Biologics”, published last year, are intended to fast-track the approval process for biosimilars and prioritise patient safety.

One of the major changes states that if the reference biologic is not authorised in India, it should be approved or licensed and marketed in a country signed up to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

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