India tightens grip on pharma quality amidst OTC regulatory push
Seeking to ensure the quality and safety of pharmaceutical products, India's regulatory bodies have intensified their crackdown on substandard and spurious drugs. The move comes at a crucial juncture as the country inches closer to establishing a comprehensive regulatory framework for over-the-counter (OTC) medications, reports The Pharma Letter’s India correspondent.
Regulators recent actions include the banning of 35 fixed-dose combination (FDC) drugs and the flagging of a spurious batch of a widely used hypertension medication, Telma, besides 131 other drugs failing quality tests.
The Central Drugs Standard Control Organization (CDSCO), India's apex drug regulatory body, is at the forefront issuing an order prohibiting the manufacture and sale of 35 FDCs.
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