India Forming Adverse Event Reporting System

India’s health ministry will soon roll out a program to collect and monitor adverse events involving medical devices, under the ongoing Pharmacovigilance Programme of India.

In the initial phase of the Materio Vigilance Programme, roughly 20 monitoring centers will be identified, Vivekanandan Kalaiselvan, principal scientific officer with the ministry’s Indian Pharmacopoeia Commission, tells IDDM.

Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry, says that a government task force will be formed in July to help shape the plan. While the initiative is much-needed, he stresses that the aim should be to provide trust in the regulatory system and not to scare people away from use of medical technology.

Vijay Venkatraman, managing director and CEO at consulting firm Oviya MedSafe, agrees. Monitoring the benefit-risk profile of medical devices is a step in the right direction toward achieving excellence in the postmarket safety of all medical products in India, he says.

The Central Drugs Standard Control Organization will work with the Sree Chitra Thirunal Institute of Medical Sciences and Technology to design the system. The plan follows a series of high-profile incidents in which faulty products harmed patients (IDDM, March 20). — Jonathon Shacat