At present, medical devices are treated like drugs and are regulated by state drug regulators under the Drugs and Cosmetics Act.
The guidelines would make it compulsory for both domestic, as well as, global medical device manufacturers to get their products certified by notified bodies, such as International Organisation for Standardisation (ISO) and Bureau of Indian Standards (BIS), before selling them in the domestic market.
The new norms will help create a level-playing field for Indian manufacturers of medical devices with global makers, such as Siemens, Philips, General Electric (GE) and LG Electronics. Medical device manufacturers, who require a free sale licence from the Indian government to export their products, were facing problems in the absence of clear regulations and necessary licenses.
The government move comes in the wake of the industry protesting against the present norms and delay in issuance of license to domestic manufacturers. The plan is not just to provide uniform norms, but also to ensure manufacture and sale of safe medical devices in the country.
“Other than the US and Europe, most of the countries, we require a free sales license from India to export our products. However, we are not readily getting the license from the government, as there are no specific rules for the industry,” Hindustan Syringes & Medical Devices joint managing director and head of Association of Indian Medical Device Industry Rajiv Nath said.
According to Nath, even as the Indian manufacturers produce medical devices worth $2.5 billion, the domestic supply is very low. Out of the $2.5 billion, export accounts for more than $1.5 billion. Europe, Middle East, Africa and North America are prime export markets for Indian medical device makers. The country imports a huge volume (worth around $1.5 billion) to meet its domestic demand.
