India’s drug regulator has drastically advanced timelines and tightened guidelines for reporting harmful effects of experimental drugs and treatments in efforts to improve oversight of the country’s pharmaceutical industry.
Companies authorised 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 in 90 calendar days, as per 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 come into effect from 1 February.
DGCI rules already require manufacturers, importers, and marketers of pharmaceutical products in India to report adverse events involving experimental drugs and treatments administered to patients after obtaining their consent. These reports have to be submitted to the Indian Pharmacopoeia Commission (IPC) and the Central Drugs Standard Control Organization (CDSCO).
Per Pubmed, a medical journal, 77 adverse drug reactions were reported in India last year—30.55% higher than in the year before. Till September this year, about 10 cases of adverse drug reactions were reported.
A spokesperson for the health ministry did not reply to queries sent on Thursday.
A uniform system
The latest pharmacovigilance document aims to strengthen the pharmacovigilance system of marketing authorization holders, said Dr Rajiv Singh Raghuvanshi, secretary-cum-scientific director, IPC, in a communication to all stakeholders dated 11 November. Marketing authorization holders, which are allowed to distribute and sell medicines, are also responsible for ensuring a drug’s safety, effectiveness, and quality, as well as complying with regulatory requirements.
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