GS-II: Governance, Polity, IR
Drug regulation and approval
Not met yet — counts as met once you answer a question on it.
Medicines and medical devices are regulated through CDSCO and the Drugs and Cosmetics Act, 1940. Clinical-trial approvals are governed by the New Drugs and Clinical Trials Rules, 2019, which set standards for subject protection and data integrity. Generic bioequivalence requirements determine whether a drug may substitute a reference product. The US FDA's inspection and warning-letter regime affects market access for India's pharmaceutical exports by flagging Good Manufacturing Practice deficiencies. Post-market surveillance and manufacturing-practice audits together determine both patient safety outcomes and the continued viability of export relationships.