Last Updated on November 3, 2026 11:50 pm by INDIAN AWAAZ
Sudhir KUmar
The Health Ministry has proposed amendments to Drugs Rules, 1945 to mandate authorisation of qualified personnel for drug batch release. Ministry of Health and Family Welfare said in a statement that the proposed amendments aim to strengthen accountability in the drug manufacturing process by introducing an explicit regulatory requirement for the authorisation of personnel responsible for batch release. While manufacturing licences currently require manufacturers to furnish details of competent technical staff responsible for manufacturing and testing, there is no specific provision for mentioning the person authorised to undertake batch release.
Applicants seeking manufacturing licences would be required to designate a suitably qualified and experienced person for batch release and maintain batch-release records in accordance with the prescribed requirements. The amendments also propose to introduce a prescribed format for the Batch Release Certificate under the Rules. Batch release is a critical stage in the pharmaceutical manufacturing process, involving an overall review of the relevant quality parameters and documentation before a batch is released for distribution.