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Separate Norms For Medical Devices Soon

The government has decided to bring separate quality guidelines for medical devices such as stents, catheters, orthopaedic implants and heart valves by end of May. The guidelines would make it mandatory for both domestic as well as global medical device makers such as Siemens, Phillips, General Electric (GE) and LG Electronics to get their products certified by notified bodies like ISO and Bureau of Indian Standards (BIS) before selling them in the Indian market. It would also classify medical devices based on the risks involved.

“The DCGI 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.

At present, medical devices are treated like drugs and are regulated by state drug regulators under the drug law - Drugs and Cosmetics Act. 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 the clear regulations and necessary licences. “Other than US and Europe, in most of the countries we require a free sales licence form 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.

Europe, Middle East, Africa and North America are prime export markets for Indian medical device makers. However, India imports a huge volume from other countries. According to Mr. Nath, even as the Indian Manufacturers produce medical devices worth $2.5 billion, the domestic supply is very low. Out of $2.5 billion, export accounts for more than $1.5 billion. To cater to its domestic demand, India imports medical devices around $1.5 billion.

“This gap is because of a clear discrimination between the indigenous manufacturers and multinational companies. While the state drug regulators expect even orthopaedic implant factories to install refrigeration units just because drug companies are mandated to do so, there is no means to inspect the facilities of those who are importing their products. Besides, their imports are fast tracked if they have Conformite Eurropeenne (CE) certificate from the European authorities or have an ISO labeling,” Mr. Nath 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. 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.

(Ref: The Economic Times Dated April 30, 2009)

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