Drug makers must name a person accountable for releasing each batch, draft rule says

Medicine manufacturers would have to name a qualified person responsible for approving each batch before it is sold, under draft changes to the Drugs Rules, 1945, proposed by the Union Health Ministry on Tuesday.

Batch release is the final check of a batch's quality test results and paperwork before it goes to distributors. Manufacturing licences already require details of technical staff for production and testing, but the ministry said there is no specific provision for the person authorised to release batches. According to a PTI report on the ministry's statement, the draft amends Rule 68, which covers licences to make drugs other than homoeopathic medicines. Applicants would have to authorise "a suitably qualified and experienced person" to release batches in line with Schedule M, the good manufacturing practice standards.

Manufacturers would also have to keep batch-release records and issue a Batch Release Certificate in a prescribed format, as proof that each batch has been reviewed. The ministry said the aim is to "strengthen accountability", make release decisions traceable and add a layer of oversight.

The proposal is a draft. Objections and suggestions can be sent to the Under Secretary (Drugs Regulation) in the Health Ministry. We could not find the gazette notice, so the deadline for comments is not yet known.