Separate regulations needed for medical devices: AdvaMed


NEW DELHI: Medical devices sector in India needs to be regulated in harmonisation with international practises and should to be treated as separate from ‘drugs’, trade association AdvaMed has said.

“There should be a separate regulatory agency for the medical devices with adequate trained personnel. Indian medical devices regulation should be harmonised with the guidelines of Global Harmonisation Task Force (GHTF),” AdvaMed Vice President Abby Pratt said.

AdvaMed is an association of medical devices makers representing 80 per cent of medical technology firms in the US and its member companies produce more than 40 percent of medical devices used annually around the world.

Pratt said given the significant differences between pharmaceuticals and medical devices, applying the same regulatory and pricing systems for medical devices could reduce the ability for Indian manufacturers to grow.

“In India the disease burden is transitioning from communicable diseases to non-communicable diseases like cancer, diabetes and heart disease and it increases the role of medical technology,” she said.

Currently only few categories of medical devices are being regulated by the regulatory body and that too as ‘drugs’ under the Drugs and Cosmetics Act, so it is important that Drugs and Cosmetics (Amendment) Bill 2013 should be passed, she added.

Highlighting the significance of medical devices sector and it’s tremendous growth potentials Pratt said: “It is valued at USD 4 billion (in India) at present but it is a very important part of the healthcare.”

The ecosystem for growth has be developed so that the sector can realise its tremendous potential to solve India’s healthcare problems, she added.


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