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Research & Reviews: A Journal of Drug Design & Discovery

Drug Approval Procedure in India (CDSCO)

  1. Praveen Agarwal
  2. Deepak Bhandary
  3. Abdul Rasheed

Abstract

A regulatory process, by which a person/organization/sponsor/innovator gets sanction to launch a drug in the market, is kenned as drug approbation process. In general, a drug approbation process comprises of sundry stages: application to conduct clinical tribulations (CT), conducting clinical tribulations, application to marketing sanction (MA) of drug and post-marketing studies (PMS). Every country has its own regulatory ascendancy, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs.Keywords: CT, PMS, MA Cite this ArticleAgarwal Praveen, Bhandary Deepak, Rasheed Abdul. Drug approval procedure in India (CDSCO). Research & Reviews: A Journal of Drug Design & Discovery. 2015; 2(2): 20–26p.
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