India plans adverse effects monitoring regime for medical devices

India's health ministry has plans to create the nation's first system for monitoring the adverse effects of medical devices. Up to now, health authorities have relied on data supplied by the world's developed countries.

Under the ministry's plan, the Central Drug Standard Control Organisation (CDSCO) would collaborate with the Sree Chitra Thirunal Institute of Medical Scientists and Technology to collect and compile adverse-event reports to track device safety records.

The system is to be tested first with the Indian Pharmacopoeia Commission in Ghaziabad, eventually leading to the national program called the Materio Vigilance Programme of India that would involve district hospitals, medical colleges and private hospitals.

India's medical device market is estimated at $3.1 billion, but a recent string of deaths associated with faulty devices prompted the government to act, according to a report in the Economic Times.

- here's the Economic Times story