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Drug Approval Procedure in India (CDSCO)By 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 …
Published in Research & Reviews: A Journal of Drug Design & Discovery · Vol. 2, Issue 2, 2015 · pp. 20–26 Read article →