Centre proposes mandatory qualified personnel for drug batch release
The Union Health Ministry intends to amend the Drugs Rules, 1945, to increase accountability in the pharmaceutical manufacturing process.
The Union Health Ministry has proposed a new requirement for drug manufacturers to designate a qualified and experienced individual to oversee the batch release of medicines. According to reports by Business Standard and The New Indian Express, the proposal includes a mandate for companies to keep specific records for every batch produced.
The proposed changes involve amending Rule 68 of the Drugs Rules, 1945, which governs manufacturing licences for the sale or distribution of drugs, excluding homoeopathic medicines. Currently, such licences are approved by the Central Licensing Approving Authority (CLAA) or its designated representative, who must be a graduate in pharmacy, pharmaceutical chemistry, or medicine with specific specialisations.
Under the new framework, manufacturing companies would be permitted to appoint their own authorised personnel for batch release, provided they meet the necessary qualification and experience standards. The ministry also plans to introduce a standard format for the Batch Release Certificate.
Ministry officials stated that while current licences require details of technical staff for manufacturing and testing, there is no specific rule for the person responsible for batch release. The amendment aims to establish clear responsibility, ensure the traceability of decisions, and provide extra oversight of product quality.
The ministry said these requirements are intended to help manufacturers improve compliance with Good Manufacturing Practices (GMP) and strengthen the regulatory framework for drug quality assurance. Stakeholders have been given 30 days from the publication of the draft notification to submit objections and suggestions.