One year minimum residual shelf-life mandated for imported drugs in India

The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, mandating a minimum residual shelf-life of one year for imported drugs at the time of import, with biological drugs and radiopharmaceuticals permitted at 60% of their labelled shelf-life. The amendment aims to reduce the risk of importing medicines nearing expiry and ensure adequate shelf-life in the Indian supply chain.

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