India releases guidelines on biosimilar approval, manufacturing

India's Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology have published guidelines on biosimilars that detail the regulatory path to marketing authorization. The 58-page "Guidelines on Similar Biologic" also details how reference products must be cited in applications as well as the eventual manufacturing process. "These guidelines are for the guidance of all stakeholders and are not meant to substitute or rephrase the rules made under Drugs & Cosmetics Act, 1940 or any other relevant Acts and are subject to being in conformity with the Drugs & Cosmetics Act and Rules as may be amended from time to time." Document (PDF)


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