The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, to require drug manufacturers to formally authorise qualified and experienced personnel for the batch release of medicines. According to the Ministry, the move aims to enhance accountability and documentation during the manufacturing process.
Under the proposed framework, those applying for manufacturing licences must designate a qualified person for batch release and keep prescribed records for every manufactured batch. A standard format for the Batch Release Certificate has also been introduced. The Ministry stated that this process ensures traceability, adds oversight of product quality, and helps manufacturers comply with Good Manufacturing Practices.
The government is inviting objections and suggestions on the proposed changes from the public and stakeholders. Submissions can be sent by post to the Ministry of Health and Family Welfare in New Delhi or via email to the designated official address.
What it means
- Drug manufacturers applying for manufacturing licences must designate a suitably qualified and experienced person to release batches.
- Manufacturers are required to maintain batch-release records in line with prescribed requirements.
Source
Press Information Bureau, Government of India, “Union Health Ministry has proposed amendments to Drugs Rules, 1945 to mandate Authorisation of qualified personnel for drug batch release”. Read the original release.
Summary of an official release for general information only. Not investment advice. Read the original source before acting on any information.
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