NEW DELHI, November 3: Every drug manufacturer in India may soon have to name a qualified person who signs off each batch of medicine before it is sold, under draft changes to the Drugs Rules, 1945, proposed by the Union Health Ministry on Tuesday. Makers would also have to keep batch-release records and issue a Batch Release Certificate in a set format.
Key highlights
- Manufacturers would have to formally authorise a person with suitable qualifications and experience to release each batch of drugs.
- They would have to keep prescribed records for every batch made.
- A standard format for the Batch Release Certificate would be added to the Rules.
- Applicants for manufacturing licences would have to designate this person when they apply.
- The draft is open for objections and suggestions from the public and industry.
What changes
| Area | Now | Under the draft |
|---|---|---|
| Licence application | Details of competent technical staff for manufacturing and testing | Also a named, qualified and experienced person authorised for batch release |
| Batch release | No specific rule naming who releases a batch | Formal authorisation of that person, with clear responsibility |
| Records | General manufacturing records | Prescribed batch-release records for every batch |
| Certificate | No prescribed format | A set format for the Batch Release Certificate |
Why it matters
Batch release is the final check before medicines leave a factory: someone reviews the quality tests and paperwork for that batch and decides whether it can be sold. The ministry says that while licences already list technical staff, there is no specific rule on who does this. Naming that person, it says, would establish clear responsibility, make release decisions traceable and add a layer of oversight on quality. It also expects the change to help manufacturers meet Good Manufacturing Practices (GMP).
How to respond
Objections and suggestions can be sent to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, U-6, Work Hall, C Wing, First Floor, Kartavya Bhawan-1, New Delhi – 110001, or by email to drugsdiv-mohfw[at]gov[dot]in. The draft notification is published in the Gazette of India; the ministry’s release did not state the comment deadline, which is set out in the gazette notice.
Our calculation
- Four changes: a named release person, mandatory designation at licence stage, prescribed batch records and a standard certificate.
- Who is affected: every applicant for a drug manufacturing licence under the relevant provisions of the Drugs Rules.
What it means
For patients, the change is meant to make it clearer who is answerable if a bad batch reaches the market. For manufacturers, especially smaller ones, it means more paperwork and the need to employ or designate a suitably qualified person for each site. The idea resembles the “qualified person” system used in some major export markets such as the European Union, which could help Indian firms that sell abroad.
What to watch
- Industry objections on cost and staffing, especially from small and medium drug makers.
- The final notification and the date from which the rule applies.
- Whether regulators link the batch-release records to inspections and recalls.
File photo: Assorted tablets and capsules. Image: MorgueFile (uploaded to Commons by Chaos), CC BY-SA 3.0, via Wikimedia Commons. Photo source · Licence
Sources
- PIB (Ministry of Health and Family Welfare): Health Ministry proposes amendments to Drugs Rules, 1945 to mandate authorisation of qualified personnel for drug batch release (November 3, 2026)
- eGazette of India (Government of India)
The National Desk covers India's politics, governance, security and public-interest news. Stories are checked against at least two credible sources before publication.
