New Delhi, Nov 4: India has proposed rules requiring regulators to immediately suspend the manufacturing licence of any drug maker whose medicine fails specified quality standards in government testing, tightening oversight of one of the world's biggest pharmaceutical industries, Reuters reported on Wednesday. The Union Health Ministry's draft amendments to the Drugs Rules, 1945 would apply when a drug fails tests for impurities, sterility, assay — the amount of active ingredient — or dissolution, which measures how the drug releases that ingredient.

Source: Reuters via Hindu BusinessLine

Under the existing rules, regulators must first issue a show-cause notice before suspending or cancelling a licence. The Health Ministry said that due-process requirement creates a time lag between a drug being declared 'not of standard quality', or NSQ, and regulatory action, ANI reported. The draft, dated October 28 but published on Wednesday, mandates immediate suspension for the specified failures instead.

Source: ANI via NewKerala

What counts as a critical failure

ANI reported the draft targets: sub-potent or over-potent active ingredient content; a drug's inability to dissolve correctly to deliver its therapeutic effect; unapproved chemical variants or degradation products; toxic or unwanted chemical contaminants; and microbially compromised injectables, eye drops or other sterile formulations.

A suspended licence will not come back automatically. It would remain suspended until the manufacturer conducts an effective root-cause analysis and implements corrective and preventive action, known as CAPA, to the regulator's satisfaction, and could be restored only after regulators verify on site that those measures have been implemented, Reuters reported. ANI added that proposed changes to Form 13 would have Government Analyst reports endorsed simultaneously to the Drugs Controller General of India (DCGI), the concerned state licensing authority, and both the manufacturer and the marketer.

Source: Reuters via Hindu BusinessLine

30 daysWindow for public comments on the draft before final rules
1945The Drugs Rules being amended
MonthlyCDSCO already publishes alerts listing drug samples declared NSQ by central and state laboratories

ANI reported the overhaul stems from recommendations of the 65th meeting of the Drugs Consultative Committee, held on December 20, 2024, and the 92nd meeting of the Drugs Technical Advisory Board, held on April 24, 2025. What happens next: the government will consider comments submitted within 30 days, and the rules would take effect on final publication in the Official Gazette. Sources: Reuters, reported by Hindu BusinessLine (November 5, 2026), and ANI, reported by NewKerala (November 4, 2026).