New Delhi, November 3, 2026 (Yes Punjab News)
The Union Ministry of Health and Family Welfare on Tuesday proposed amendments to the Drugs Rules, 1945, to strengthen accountability and traceability in pharmaceutical manufacturing by making authorised personnel responsible for approving drug batches for market release.
Under the proposed changes, manufacturers applying for licences under the relevant provisions of the rules will have to nominate a suitably qualified and experienced person to oversee batch-release functions. They will also be required to maintain prescribed records for each batch and issue certificates in a specified format.
The ministry said the proposal addresses a gap in the existing regulatory framework. While manufacturers must provide details of technical staff responsible for manufacturing and testing, the rules do not specifically require them to identify the person authorised to approve batches for market release.
Batch release involves reviewing manufacturing records, quality-control data and other relevant documents before a drug is cleared for distribution. The proposed changes seek to establish clear accountability for these decisions, improve traceability and strengthen quality oversight.
The amendments also provide for a standardised Batch Release Certificate as documentary evidence that a batch has undergone the required review and meets prescribed quality standards before entering the supply chain.
The ministry said the requirements are expected to improve compliance with Good Manufacturing Practices (GMP) and reinforce the drug quality assurance framework.
The Health Ministry has invited comments and suggestions from stakeholders and the public. Feedback can be submitted to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, or through the email address notified by the ministry.
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