India mandates faster reporting of drug side effects

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.

The new rules are also meant to establish a uniform pharmacovigilance system—a process for monitoring and preventing adverse effects of pharmaceutical products—for drug manufacturers, importers, distributors and marketers. The DCGI document also provides a framework for licence holders to establish and ensure an effective pharmacovigilance system at their organisation. 

The organisations involved will have to collate cases of adverse effects arising due to a drug and submit periodic safety update reports to the authorities. The main objective of these reports is to present a comprehensive, concise and critical analysis of new information on the risks and benefits of pharmaceutical products.

The updated guidelines also state that if a pregnant woman has been exposed to any medication that can cause congenital disorders in an unborn child, follow-ups should be done till the delivery of the child to assess the outcome. Adverse reactions in infants following exposure to a pharmaceutical product from breast milk should also be reported,” it states.

“Pharmacovigilance is… fundamental for the safety of the patients, especially pregnant women and breastfeeding mothers because they are at a greater risk of side effects,” said Sudarshan Jain, secretary general, Indian Pharmaceutical Alliance, representing domestic pharmaceutical companies. “These documents are very handy tools for companies to establish a story pharmacovigilance system…”