NEW DELHI, November 5 (Aalimi Nation) – The Union Health Ministry has proposed changes to the Drugs Rules, 1945, that would allow regulators to suspend a manufacturer's licence immediately once a medicine is declared not of standard quality on critical parameters. The draft amendments are open for public comment for 30 days.
Under the proposal, a Government Analyst's report that flags a drug as not of standard quality on specified critical parameters could be enough for the licensing authority to act. The Central Licensing Approving Authority or the concerned State Licensing Authority would be able to suspend the manufacturing licence straight away. The parameters mentioned include assay, dissolution, related substances, impurities and sterility.
At present, suspending or cancelling a licence follows a prescribed procedure that includes a show-cause notice to the manufacturer. The Ministry's draft would remove that step in cases of critical quality failure, so that production and distribution of the affected product can be halted promptly.
The test report would go to the Drugs Controller General of India, the licensing authority where the manufacturing site is located, and the manufacturer and marketer.
The draft does not make a suspension permanent. A suspended licence would stay in force until the manufacturer carries out an effective root cause analysis and puts corrective and preventive action in place to the satisfaction of the licensing authority. The suspension could be revoked only after the authority has verified those measures.
The Ministry said the amendments are meant to strengthen post-marketing surveillance, enable timely action against substandard medicines and increase accountability among manufacturers and marketers. It said the overall aim is to protect patient safety and public health.
Stakeholders and members of the public can send objections and suggestions to the Under Secretary (Drugs) at the Ministry within 30 days of the draft rules being made available to the public through the Gazette of India.
The proposal follows deliberations in the drug regulatory system. The Drugs Consultative Committee discussed the issue at its 65th meeting on December 20, 2024, and the Drugs Technical Advisory Board made recommendations at its 92nd meeting on April 24, 2025.
Quality enforcement against drug makers is not new. In March 2023, an official source said the Drugs Controller General of India's office, working with states, had inspected 76 pharmaceutical companies over about 15 days. Of those, 18 licences were suspended, 26 companies received show-cause notices and product permissions of three companies were cancelled. That drive covered units in 20 states.
The Ministry's announcement does not list every critical parameter that would trigger immediate suspension, and it does not cite any specific drug or company as the reason for the move.
Once the 30-day consultation period ends, the Ministry is expected to examine the comments received before deciding whether to notify the final amendments. Until then, the existing procedure, including show-cause notices, continues to apply.
