Centre proposes mandatory qualified personnel for drug batch release
The Union Health Ministry plans to amend the Drugs Rules, 1945, to ensure accountability in the pharmaceutical manufacturing process.
The Union Health Ministry has proposed a new requirement for drug manufacturers to officially appoint a qualified and experienced individual to oversee the batch release of drugs. According to reports by Business Standard and The New Indian Express, the proposal also includes a mandate to keep specific records for every manufactured batch.
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, licences are approved by the Central Licensing Approving Authority (CLAA) or a designated person who must be a graduate in pharmacy, pharmaceutical chemistry, or medicine with specific specialisations.
Under the new framework, companies would be permitted to appoint their own qualified personnel for this role. The ministry also intends to introduce a standardised format for the Batch Release Certificate.
The ministry stated that batch release is a vital stage where quality parameters and documentation are reviewed before distribution. The new rules aim to establish clear responsibility, ensure the traceability of decisions, and provide extra oversight regarding product quality.
Officials from the Union Health Ministry told Business Standard that while current licences require details of technical staff for manufacturing and testing, there is no specific rule for the person handling batch release. The amendments are expected to help manufacturers comply with Good Manufacturing Practices (GMP).
Stakeholders have been given 30 days from the publication of the draft notification to submit their suggestions and objections.