On behalf of Ministry, Additional Secretary K B Agarwal recently issued an advisory to all state governments and Central Health Agencies to include (CDSCO) approved medical devices.
Association of Indian Medical Device Industry (AIMED) has warmly welcomed the advisory issued by the Ministry of Health and Family Welfare, Government of India, to all State Governments and Central Health Agencies to include and encourage domestic standards for procurement of medical devices in tender specifications by various health agencies.
On behalf of Ministry, Additional Secretary K B Agarwal recently issued an advisory to all state governments and Central Health Agencies to include Central Drugs Standard Control Organization (CDSCO) approved medical devices for being considered for procurement of medical device and desist from insistence of USFDA approvals.
The advisory is being seen by the industry as a much needed move to usher in price parity and create a level playing field between domestically produced medical devices and imports while catalyzing Prime Minister Narendra Modi’s vision of ‘Make in India’, galvanizing domestic manufacturing, reduce humungous import dependency and bring down overall healthcare cost for common citizens.
“We are hugely delighted and absolutely thankful to the Ministry of Health and Family Welfare and KB Agarwal for this much needed and timely advisory. Medical device sector is one of the corner stone of PM Modi’s ‘Make in India’ Vision. This advisory will help create a level playing field between domestically produced medical devices and imports. If implemented in right spirit by all states, this will catalyze domestic manufacturing and boost up demand for India manufactured goods while bringing down overall healthcare cost,” said Rajiv Nath, Forum Coordinator, AIMED.
“Insistence on the ‘Exclusionary USFDA Certification’ requirement for technical bid is a grossly discriminatory practice as it only favours large US companies in domestic public healthcare procurement process. This insistence is a pure absurdity and has resulted in exclusion of Indian manufacturers from even having access to our own Indian market and even disallowed manufacturers from other countries from bidding and thereby hiking up the healthcare costs,” says Mr Nath.
The ministry’s advisory has recommended that the States/UTs may (i) advise all concerned to ensure that in all proposals relating to procurement, CDSCO approved medical devices should invariably be indicated as a category in the tender documents for procurement, and (ii) the technical specifications designed by the Ministry of Health and Family Welfare and NHSRC may as far as possible be used for all procurements in future to ensure uniformity.