India issues draft bioequivalence request format for drugs aimed for export

SINGAPORE--A uniform format by India's Central Drugs Standard Control Organization (CDSCO) to file requests for bioequivalence studies in India on drugs manufactured for export put into a draft for comment.

The draft covers study requests for: New molecules approved in other countries but not India; drugs approved in India within one year; drugs approved in India in a period of one to four years; drugs in modified release form irrespective of their approval status; and so-called old drugs approved in India for more than four years. The deadline for comments is Jan. 25, 2015.

- view the draft (PDF)

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