Daijiworld Media Network - New Delhi
New Delhi, Nov 3: The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, to strengthen accountability and traceability in pharmaceutical manufacturing by making it mandatory for manufacturers to appoint authorised personnel for batch-release decisions.
Under the proposed changes, drug manufacturers seeking licences under the relevant provisions of the Drugs Rules, 1945, will have to nominate a suitably qualified and experienced individual to perform batch-release functions.
Manufacturers will also be required to maintain prescribed records relating to the release of each batch and issue batch-release certificates in a specified format.
The ministry said the move was aimed at addressing 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 mandate the identification of the person authorised to approve batches for release into the market.
Batch release is a crucial stage in pharmaceutical manufacturing, involving a comprehensive review of manufacturing records, quality control data and other relevant documents before products are cleared for distribution.
The proposed amendments seek to establish clear accountability 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 improve compliance with applicable Good Manufacturing Practices (GMP) and further reinforce the regulatory framework governing quality assurance in the pharmaceutical sector.
The proposed changes also introduce a prescribed format for a Batch Release Certificate, which will serve as documentary evidence that a particular batch has undergone the required review and meets the stipulated quality standards before entering the supply chain.
The Health Ministry has invited comments and suggestions from stakeholders and members of the public on the proposed amendments.
Objections and feedback can be submitted to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, or sent through the designated email address notified by the ministry.