Government proposes enhanced batch-release controls under the Drugs Rules, 1

India's Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, requiring manufacturers of drugs to authorise qualified personnel for batch release as per the GMP requirements. The proposal also introduces a prescribed Batch Release Certificate and batch-wise documentation covering manufacturing, testing and quality checks. Loan licensees and manufacturer of blood products would also be required to maintain batch-release records for every batch manufactured under their licences strengthening accountability for quality oversight even where manufacturing is undertaken at another licensee’s premises.

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