The Drug Controller General of India (DCGI) has already issued a regulation outlining the need for makers, importers, and sellers of drugs, to report adverse events. However, on November 11, to enhance overall supervision, India issued a new pharmacovigilance document to major stakeholders. This new document requires serious adverse events (death, etc.) to be reported within fifteen days of learning of such an event and ninety days for other bad reactions to a drug. Last year, about 70 adverse events were reported (a 31% increase over the year before), and 12 adverse events have been reported through the middle of this year. This is not many, given the size of India and the prevalence of drug use. The new document hopes to increase such reporting dramatically.
The new document also requires drug license holders to implement their own strong pharmacovigilance system internally.
Drug license holders will need to report adverse events via better internal systems and detail their safety reports to the Indian government – both the Indian Pharmacopoeia and the Central Drugs Standard Control Organization (CDSCO). These reports should provide a critical analysis of the benefits and risks of drugs they hold licenses for. Failure to do so will result in large penalties and potentially revoke drug licenses. The document has several other important clauses. For example, it specifically states that drugs that can affect pregnant women or unborn children must be reported immediately.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.