India needs to address major problems of adverse drug reactions

The monitoring of adverse drug reactions (ADRs) has become paramount in India, with the country eager to put in place regulatory mechanisms to curb the menace of rising ADRs, as well as continue with its emphasis on collection of data on ADRs to ensure patient safety, reports The Pharma Letter’s India correspondent.

Based on ADRs collected by the Drug Monitoring and Reporting Centers under the Pharmacovigilance Program of India, the Central Drugs Standard Control Organization (CDSCO), the apex drugs regulator in India, is also to initiate regulatory action.

"The innate tendency is to hush up such cases. As new and more drugs are being introduced into the market, like high tech pharma products, New Chemical Entities (NCEs), vaccines, new therapeutic claims of existing drugs as well as new routes of drug administrations, there are several challenges to monitoring ADRs given the large population base," said a government official.