Health ministry to suspend drug licences instantly if products flagged as sub‑standard

What Happened

The Union Ministry of Health and Family Welfare has drafted an amendment to the Drugs Rules, 1945 that would let regulators suspend a drug maker’s manufacturing licence the moment a government analyst declares a product “not of standard quality” (NSQ). The suspension remains until the company completes a root‑cause analysis and takes corrective steps that satisfy the licensing authority. The amendment lists assay, dissolution, related substances, impurities and sterility as the key parameters that trigger an NSQ finding. Under the draft, the analyst’s report would be entered on Form 13 and sent to the Drugs Controller General of India, the state or UT licensing authority where the plant is located, and to both the manufacturer and the marketer. The ministry says the move will close the gap created by the current process, which requires a show‑cause notice before any action and can allow sub‑standard drugs to stay on the market. By enabling prompt suspension, the proposal aims to protect patients and strengthen overall drug‑quality compliance. The changes were discussed at the 65th meeting of the Drugs Consultative Committee on 20 December 2024 and at the 92nd meeting of the Drugs Technical Advisory Board on 24 April 2025, both of which recommended faster regulatory response to unsafe medicines.

Context

The amendment seeks to speed up action against sub‑standard drugs, a step seen as necessary after past delays let unsafe medicines circulate, posing public‑health risks.