AdvaMed, an association of medical device manufacturers, stressed that
in the light of many regulatory hurdles the industry is facing in India,
it is high time for the government to frame a specific set of acts and
rules for the medical devices industry. The association welcomed the
government’s effort to create a distinction between medical devices and
drugs through a separate chapter in the Drugs & Cosmetics
(Amendment) Bill, and its commitment to tackling non- communicable
diseases.
AdvaMed pointed out that in the long run, a separate Act would enable the industry to effectively address India’s healthcare challenges. Sanjay Banerjee, chair of AdvaMed India said, “For decades in India, the medical device industry has gone unrecognised as a distinct pillar of the healthcare sector. Of the 14000 types of medical devices, only 14 are on the regulator’s list and even these are treated as drugs. There is a misconception here that medical devices and drugs are the same because they are both used to treat diseases. The obfuscation of the two categories in India has limited the ability of the sector to address India’s healthcare needs. There is a major gap between devices used and what is needed.”
AdvaMed pointed out that in the long run, a separate Act would enable the industry to effectively address India’s healthcare challenges. Sanjay Banerjee, chair of AdvaMed India said, “For decades in India, the medical device industry has gone unrecognised as a distinct pillar of the healthcare sector. Of the 14000 types of medical devices, only 14 are on the regulator’s list and even these are treated as drugs. There is a misconception here that medical devices and drugs are the same because they are both used to treat diseases. The obfuscation of the two categories in India has limited the ability of the sector to address India’s healthcare needs. There is a major gap between devices used and what is needed.”
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