The Health Ministry has proposed amendments to the Drugs Rules, 1945, that would require drug makers to formally authorise a qualified person for batch release and keep records for every batch.
At present, manufacturing licences require details of competent technical staff for manufacturing and testing, but no specific provision names the person authorised to release a batch.
What is proposed
Applicants for manufacturing licences would have to designate a suitably qualified and experienced person for batch release and maintain batch-release records. The amendments also introduce a prescribed format for a Batch Release Certificate.
Why
The ministry says batch release is a critical stage, involving an overall review of quality parameters and documentation before distribution. The proposals aim to fix clear responsibility, make decisions traceable and add an oversight layer, and should help manufacturers meet Good Manufacturing Practices. These are proposals, not final rules; the release does not give a deadline for comments.
Source: official release by the Ministry of Health and Family Welfare, issued through the Press Information Bureau, Government of India (03 NOV 2026 6:43PM by PIB Delhi). Read the full official text: Union Health Ministry has proposed amendments to Drugs Rules, 1945 to mandate Authorisation of qualified personnel for drug batch release.
How we verified this
VerifiedEvery fact, figure and quotation is taken from the official PIB release (Release ID 2332192) issued by the Ministry of Health and Family Welfare on 03 NOV 2026 6:43PM by PIB Delhi; checked against the source on publication. Story written by BDT from that release; no outside facts added.
Sources
- 1.Union Health Ministry has proposed amendments to Drugs Rules, 1945 to mandate Authorisation of qualified personnel for drug batch release — Press Information Bureau, Government of India
