NEW DELHI: The Central government has, for the first time, formed an advisory committee to look into the regulation of aspects related to medical devices in the country.The Medical Devices Technical Advisory Group headed by Drug Controller General of India will have a total of 22 members that will include experts from various public and private health institutions and industry representatives.
The group has been formed with a mandate to examine “the issues related to implementation of medical devices regulations and suggest the Central Drug Standard Control Organisation regarding strengthening of medical devices regulation”. Officials in the health ministry said the move was aimed at giving focused attention on medical devices as 5,000-6,000 devices are used in the health sector in India.
The development comes after the health ministry took a step in the direction of ensuring monetary compensation to patients suffering due to faulty devices or implants sold by the companies manufacturing or importing them. The Drugs Technical Advisory Board, India’s apex drugs advisory body, had a few months back given green signal for amending the country’s rules for medical devices to
include provisions for compensation.
The move came after the US medical device major Johnson and Johnson was directed to compensate patients who had suffered severe complications due to faulty hip implants manufactured by it. This was the first such instance of awarding damages for faulty implants in India. Industry experts welcomed the latest government move saying it was good to have a forum where all stakeholders could share their concerns related to these devices.
“The fact that the relevant government agencies, industry association and government healthcare practitioners have been given a say in the MDTAG is a good beginning,” said Pavan Choudary, director general of the Technology Association of India. “Other experts can be co-opted as the agenda rolls along,” he added.