Drug Approval Procedure in India (CDSCO)

Praveen Agarwal, Deepak Bhandary, 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 Article

Agarwal 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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