‘MedTech sector should be regulated separately’

AdvaMed has said that there is need for separate regulations for the medical device industry


Currently, medical devices have been categorized as 'drugs' under the Drugs and Cosmetics Act

The medical devices sector should be excluded from the drugs category and needs to be regulated as per international practices, said the Advanced Medical Technology Association (AdvaMed). Currently, medical devices are catagorized as "drugs" under the Drugs and Cosmetics Act. According to AdvaMed, applying the same regulatory and pricing systems for medical devices as pharmaceuticals could reduce the ability of Indian manufacturers to grow.

"There should be a separate regulatory agency for medical devices with adequate trained personnel. Indian medical devices regulation should be harmonized with the guidelines of the Global Harmonization Task Force (GHTF)," AdvaMed vice president Ms Abby Pratt said in a statement.

"Medical device industry is valued at $4 billion in India at present but it is a very important part of healthcare. The ecosystem for growth has be developed so that the sector can realize its tremendous potential to solve India's healthcare problems," she added.


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