The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, to make it mandatory for drug manufacturers to formally authorise qualified and experienced personnel for the release of drug batches.
The proposed amendments aim to strengthen accountability, improve documentation and enhance quality assurance in pharmaceutical manufacturing by clearly identifying the personnel responsible for approving drug batches before they are released for distribution.
Under the proposed framework, applicants seeking manufacturing licences under the relevant provisions of the Drugs Rules, 1945, will be required to designate a suitably qualified and experienced person for batch release. Manufacturers will also have to maintain prescribed records for every batch produced.
The amendments further propose introducing a standardised format for the Batch Release Certificate under the Rules.
Batch release is a crucial stage in pharmaceutical manufacturing, involving a comprehensive review of quality parameters and relevant documentation to ensure that a drug batch meets the prescribed standards before being made available for distribution.
At present, manufacturing licence applications require details of competent technical personnel responsible for manufacturing and testing. However, the existing provisions do not specifically require manufacturers to identify the person authorised to undertake batch release.
The proposed changes seek to address this gap by establishing clear responsibility for batch-release decisions and ensuring better traceability and regulatory oversight.
According to the Ministry, the proposed requirements are also expected to help pharmaceutical manufacturers strengthen compliance with applicable Good Manufacturing Practices (GMP) and reinforce the regulatory framework governing drug quality assurance.
The Ministry has invited objections and suggestions from stakeholders on the proposed amendments. Submissions can be sent to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, Government of India, U-6, Work Hall, C Wing, First Floor, Kartavya Bhawan-1, New Delhi – 110001.
Suggestions and objections can also be submitted through email at drugsdiv-mohfw@gov.in.
Published: Wednesday, 4 November 2026 | 12:49 PM IST