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THE government has decided to create separate quality guidelines for medical devices and not treat them as drugs by the end of May. It will also classify medical devices based on the risks involved. At present, medical devices are treated like drugs and are regulated by state drug regulators under the drug law - Drugs and Cosmetics Act.
The guidelines would make it mandatory for both domestic as well as global medical device makers to get their products certified by notified bodies like International Organization for Standardization (ISO) and Bureau of Indian Standards (BIS) before selling them in the Indian market.

The new norms will help create a levelplaying field for Indian manufacturers of medical devices with global makers like Siemens, Philips, General Electric (GE) and LG Electronics. Medical device manufacturers, who require a free sale licence from the government of India to export their products, were facing problems in the absence of clear regulations and necessary licences.

"The Drugs Controller General of India has finalised the guidelines for regulating medical devices and have submitted them to the Drug Technical Advisory Board for an approval. The guidelines are likely to be notified by the end of May," an official in the health ministry said. The government move comes in the wake of the industry protesting against the present norms and delay in issuance of licence to domestic manufacturers. The idea 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, in most of the countries we require a free sales licence from India to export our products. However, we are not readily getting the licence 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 Mr 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. India imports a huge volume (worth around $1.5 billion) from other countries to meet its domestic demand.

"This gap is because of a clear discrimination between the indigenous manufacturers and multinational companies," Mr Nath said. The domestic medical device industry is estimated to be around $2.17 billion, growing 15% a year. According to estimates, it is expected to reach $4.97 billion by 2012.

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