Drug Rule 1945 amendment proposed: licences of substandard medicines can be suspended at once
The Union Health Ministry has put out a draft amendment to the Drugs Rules, 1945, so that manufacturing licences of medicines failing quality standards can be suspended immediately. It applies to drug makers and sellers; the public can send objections or suggestions within 30 days.
What this means for you
The change is meant to protect patients, but ordinary readers have no form or application to fill. If you want to comment on the draft, you can send your objection or suggestion by post or e-mail within 30 days of the draft rules being made available in the Gazette. This is still a proposal, so the final rules may differ.
Key facts
- A draft amendment to the Drugs Rules, 1945 has been issued for public consultation.
- Licences can be suspended at once for medicines failing standards on testing, dissolution, related substances, impurities or sterility.
- A suspended licence can be restored only after the manufacturer does a root cause analysis and applies corrective and preventive action (CAPA), verified by the authority.
- The government analyst's report will go to DCGI, the state or UT licensing authority, and the manufacturer and marketer of the drug.
- Objections and suggestions can be sent within 30 days of the draft being made available in the Gazette.
- The proposal is based on the 65th DCC meeting (20 December 2024) and the 92nd DTAB meeting (24 April 2025).
What has changed
The Ministry of Health and Family Welfare has issued a draft amendment to the Drugs Rules, 1945. The aim is to allow immediate suspension of the manufacturing licence of a medicine that fails the prescribed quality standards.
According to the ministry, current rules require a set process before a licence is suspended or cancelled, including issuing a ‘show cause notice’. This can leave a gap between a drug being declared not of standard quality (NSQ) and action being taken against it. During that time the medicine may stay in the market, which can put public health at risk and make a recall harder.
Who benefits
Under the proposal, the Central Licensing Approval Authority or the State Licensing Authority, as applicable, can suspend the manufacturing licence at once on receiving a government analyst’s report. The report must declare the drug NSQ on testing, dissolution, related substances, impurities or sterility.
The ministry says the changes are expected to strengthen monitoring of medicines in the market, allow timely action against low-quality drugs and raise accountability of manufacturers and sellers.
Conditions for restoring a licence
The suspension will continue until the manufacturer carries out a root cause analysis of the quality failure and applies corrective and preventive action (CAPA) to the satisfaction of the licensing authority. The authority will verify these steps before the licence is restored.
Where the report goes
Changes are also proposed in ‘Form 13’, which relates to the government analyst’s test report. Under the proposed system, the report will be sent to the Drugs Controller General of India (DCGI), the licensing authority of the concerned state or union territory, and the manufacturer and marketer of the drug.
How to send suggestions
The draft has been issued for public consultation. Objections and suggestions can be sent within 30 days of the draft rules being made available to the public in the Gazette. These can be sent to the Under Secretary (Drugs), Ministry of Health and Family Welfare, U-6, Work Hall-C Wing, First Floor, Kartavya Bhawan-1, New Delhi-110001, or by e-mail to drugsdiv-mohfw[at]gov[dot]in. The draft Gazette notification can be seen on the official e-Gazette portal.
The ministry says the proposals are based on discussions at the 65th meeting of the Drugs Consultative Committee (DCC) held on 20 December 2024 and recommendations of the 92nd meeting of the Drugs Technical Advisory Board (DTAB) held on 24 April 2025.
Questions and answers
When will the new rule on substandard medicines come into force?
It is only a proposal right now and no date is fixed. The draft has been issued for public consultation and suggestions are invited for 30 days.
Which medicines can have their licence suspended?
Medicines that fail the prescribed standards on testing, dissolution, related substances, impurities or sterility. Such a drug is declared NSQ, or not of standard quality, in the government analyst's report.
How can a suspended licence be restored?
The manufacturer must do a root cause analysis of the quality failure and apply corrective and preventive action (CAPA). The licence can be restored only after the licensing authority verifies these steps.
How can an ordinary person send a suggestion?
Send your objection or suggestion to the Under Secretary (Drugs), Ministry of Health and Family Welfare, U-6, Work Hall-C Wing, First Floor, Kartavya Bhawan-1, New Delhi-110001. It can also be e-mailed to drugsdiv-mohfw[at]gov[dot]in.
What is the last date to send suggestions?
Suggestions can be sent within 30 days of the draft rules being made available to the public in the Gazette. The draft can be seen on the official e-Gazette portal.
Source: PIB, "केंद्रीय स्वास्थ्य एवं परिवार कल्याण मंत्रालय ने उन दवाओं के विनिर्माण लाइसेंस तुरंत निलंबित करने का प्रस्ताव रखा है जो निर्धारित महत्वपूर्ण मानकों पर खड़ा नहीं उतरती हैं", 4 November 2026. Read the original notice
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