Drugs Rules 1945 amendment proposed: makers must authorise qualified staff for every batch release
The Union Health and Family Welfare Ministry proposed on 3 November 2026 an amendment to the Drugs Rules, 1945. It will affect medicine manufacturers, who must now formally authorise a qualified person for batch release and keep records.
What this means for you
This proposal is not aimed directly at ordinary readers; it concerns medicine manufacturers and their staff. The aim is to fix clear responsibility and add a layer of quality oversight for drug batches. If you are a manufacturer or work in this area, you can send objections or suggestions to the ministry.
Key facts
- The Health and Family Welfare Ministry has proposed an amendment to the Drugs Rules, 1945.
- Applicants seeking a manufacturing licence will have to appoint a person with suitable qualification and experience for batch release.
- Records of batch release will have to be maintained as per prescribed requirements.
- A prescribed format for a 'batch release certificate' is also proposed.
- Objections or suggestions can be sent to 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 emailed to drugsdiv-mohfw[at]gov[dot]in.
What has happened
The Union Ministry of Health and Family Welfare has proposed an amendment to the Drugs Rules, 1945. The aim is to make it mandatory for medicine manufacturers to formally authorise the person who releases drug batches and to keep prescribed records for every batch produced.
What the current system says
Under existing manufacturing licences, producers have to give details of competent technical staff responsible for manufacturing and testing. But there is no specific provision to name the person authorised to release a batch. The proposed amendments seek to fill this gap.
What the proposal changes
Under the proposed framework, applicants seeking a manufacturing licence will have to appoint a person with suitable qualification and experience for batch release. They will also have to maintain records of batch release as per prescribed requirements. The amendments also propose a prescribed format for a ‘batch release certificate’.
Why batch release matters
Batch release is an important step in drug production. Before any batch is released for distribution, its quality standards and documents are reviewed in detail. The ministry says these proposed requirements will fix clear responsibility for this work, allow tracking of batch release decisions and add a layer of monitoring over product quality.
Who is affected
The ministry expects these amendments to help strengthen compliance with Good Manufacturing Practices (GMP) among producers and further firm up the regulatory framework for drug quality assurance. The proposal concerns medicine manufacturers and those linked to licensing; ordinary patients do not need to do anything under it.
How to send suggestions
Anyone with objections or suggestions on the proposed amendments can send them to Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, Government of India, U-6, Work Hall, C Wing, First Floor, Kartavya Bhawan-1, New Delhi-110001, or email drugsdiv-mohfw[at]gov[dot]in. The official gazette can be seen through the link given in the ministry’s release.
Questions and answers
Who has proposed the amendment to the Drugs Rules, 1945?
The Union Ministry of Health and Family Welfare has proposed it. The aim is to strengthen accountability and documentation in drug manufacturing.
Who will have to make changes under this proposal?
Applicants seeking a manufacturing licence. They will have to appoint a person with suitable qualification and experience for batch release and maintain prescribed records.
What is the batch release certificate?
The amendments propose a prescribed format for a 'batch release certificate'. It is meant to help track decisions linked to releasing a batch.
Where can I send objections or suggestions?
To 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.
Does this directly affect ordinary patients?
The proposal is about medicine manufacturers and licensing rules. Ordinary patients do not need to do anything under it.
Source: PIB, "केंद्रीय स्वास्थ्य मंत्रालय ने दवा की खेप जारी करने के लिए योग्य कर्मियों को अधिकृत करने को अनिवार्य बनाने के लिए औषधि नियमावली, 1945 में संशोधन का प्रस्ताव रखा", 3 November 2026. Read the original notice
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