Call for health industry regulation in India

Wednesday, 22 September 2004, 07:00 Hrs   |    2 Comments
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NEW DELHI: An informal group of health industry executives working towards policy and regulatory issues in different countries, Wednesday urged for setting up a medical regulatory system in India.

Despite the rapid growth in medical devices industry in the last ten years, several countries including India are yet to establish a system for addressing local regulation of medical devices, said the Global Health Policy Group (GHPG).

"Without regulation and credible sciences, patients and physicians are at risk not getting or providing optimal medical care and in some cases inferior care," GHPG said in a statement.

The group that is planning to set up a framework in India to address local issues has pointed out the incidence of clogging after ordinary stenting (to remove and prevent clogging in arteries of the heart) is as high as 50 percent in this country.

"Drug eluting (extracting) stents have not been brought under the definition of drug as stated under the Drugs and Cosmetics Act of 1940, and therefore its quality is not regulated," the group said.

"Also, lack of device regulation in India may put the local industry at a disadvantage because for export it must conform to regulation in their importing country and demonstrate that the device has obtained local approval."

Several major drug and device companies in the US and major global markets are members of the group.


Source: IANS
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