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Regulatory Focus™ > News Articles > India Proposes New Requirements for Bioequivalence Studies

India Proposes New Requirements for Bioequivalence Studies

Posted 22 January 2015 | By Louise Zornoza

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India’s Central Drugs Standard Control Organization (CDSCO) is soliciting input on a draft guidance that establishes a uniform format for filing requests for the approval of bioequivalence studies that are to be conducted in India on drugs intended for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.

(CDSCO Draft Guidance)

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