Overview of biologic regulations in India
Currently, all biologics in India, including innovative and copy biologics are approved as new drugs, notes a new report added to the offering of Ireland-based ResearchandMarkets, titled Biosimilars: India Update.
However, in July 2011, India’s Department of Biotechnology proposed draft guidance outlining an abridged procedure for the preclinical evaluation of similar biologics in India, with the DBT currently awaiting draft guidance on clinical trials for biosimilars from the Drug Controller General of India.
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