Any new drug, which is to be marketed in India, needs to undergo a battery of tests according to the “New Drugs and Clinical Trials Rules, 2019.” These rules are enforced by Central Drugs Standards Control Organization (CDSCO). These tests are to be carried out to prove that the drug is safe and effective to treat the human diseases. Prior to clinical trials in humans, the drug must have desired pharmacological activity and no toxic effects in animals. The experimental protocols to be followed need to be approved by the Ethics Committee for trial to be registered. Clinical studies are generally carried out in four stages/Phases.
General Comment: For the details related to forms and fees for new drug approval processing in India refer the Eighth Schedule and Sixth Schedule of New Drugs and Clinical Trials Rule, 2019 [G.S.R. 227(E)].
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