India Proposes New Requirements for Bioequivalence Studies
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India’s Central Drugs Standard Control Organization (CDSCO) is soliciting input on a draft guidance that establishes a uniform format for filing requests for the approval of bioequivalence studies that are to be conducted in India on drugs intended for export.
The uniform formats cover study requests for:
- a new molecule approved in another country but not India
- drugs approved in India within the last year
- drugs approved between one and four years ago
- drugs in modified release form irrespective of their approval status
- so-called "old drugs" approved in India for more than four years
The deadline for comments is 25 January 2015.