Ministry’s advisory urges non-insistence on USFDA approvals for technical bid and o actively encourage and consider CDSCO approved goods.
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 Shri K B Agarwal recently issued an advisory to all State governments and Central Health Agencies to include 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 Shri 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 Mr Rajiv Nath, Forum Coordinator, AIMED.
It may be known that due to legacy reasons and blind imitations, tenders by Central and State health agencies have typically insisted on USFDA certifications to qualify for the same, thus creating a big disadvantage for domestic manufacturers. The tenders often do not even consider alternative options such as ISO 13485 Certification. This resulted in as the ministry's advisory states "denial of fair chance to the domestic manufacturers to compete in such procurements." The advisory also states that "such practice not only impedes competition, but also affects the ‘Make in India' effort.