Government proposes mandatory batch-release authorisation for drug manufacturers
The Union Ministry of Health and Family Welfare on Tuesday proposed changes to the Drugs Rules, 1945, aimed at enhancing accountability and traceability in pharmaceutical manufacturing by mandating the appointment of authorised personnel for batch release of drugs.
Under the proposed amendments, drug manufacturers seeking licences under the relevant provisions of the Drugs Rules, 1945, will be required to nominate a suitably qualified and experienced individual to undertake batch-release functions. Manufacturers will also have to maintain prescribed records related to the release of each batch and issue batch-release certificates in a specified format.
The ministry said the move seeks to address a regulatory gap in the existing framework.
While manufacturers are already required to provide details of competent technical staff responsible for manufacturing and testing activities, the current rules do not specifically require identification of the person authorised to approve batches for market release.
Batch release is a critical stage in the pharmaceutical manufacturing process, involving a comprehensive review of manufacturing records, quality control data and other relevant documentation before products are cleared for distribution.
The proposed amendments are intended to establish clear responsibility for batch-release decisions, improve traceability and strengthen oversight of product quality.
According to the ministry, the new requirements are expected to help drug manufacturers enhance compliance with applicable Good Manufacturing Practices (GMP) while reinforcing the regulatory framework governing drug quality assurance.
The proposed amendments also introduce a formal format for a Batch Release Certificate, which would serve as documentary evidence that a batch has undergone the required review and meets prescribed quality standards before being released into the supply chain.
The Health Ministry has invited comments and suggestions from stakeholders and the public on the proposed amendments.
Objections or feedback can be submitted to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, or sent via email to the designated address notified by the ministry.
