DGCI accelerates reporting timeline for adverse effects

Come 1 Feb, India to enforce stricter drug safety rules, mandating 15-day reporting window

- Priyanka Sharma

India's drug regulator has drastically advanced timelines and tightened the guidelines for reporting harmful effects of experimental drugs and treatments in efforts to improve oversight of the country's pharmaceutical industry.

The companies authorized to market medicines must report any serious adverse effects caused by a drug or treatment—such as death, disability, or a life-threatening condition—within 15 calendar days of receiving such information.

Other harmful reactions to an investigational drug or a pharmaceutical product must be reported within 90 calendar days, according to the latest pharmacovigilance guidance document released by the Drugs Controller General of India (DCGI). Mint has seen a copy of the document.

Adverse effects due to poor efficacy of a drug or medication error must also be reported to the authorities, according to the latest document.

The new rules will come into effect from 1 February 2025.