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NewsOnAir 2026-11-03
Centre Proposes Mandatory Authorization for Qualified Personnel in Drug Batch Release The Health Ministry has proposed amendments to the Drugs Rules, 1945, to require the authorization of qualified personnel for drug batch release. This initiative aims to enhance accountability in the drug manufacturing process by establishing a regulatory requirement for designating personnel responsible for batch release. Currently, while manufacturers must provide details of technical staff, there is no specific requirement for the individual authorized to release batches. The proposed changes also include a standardized format for the Batch Release Certificate, emphasizing the importance of quality review before distribution.
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