MedTech Industry urges authorities to replace exclusive FDA requirement

Medical device industry urges centre and states to replace ‘exclusive USFDA requirement’ with more inclusive and democratic technical certifications


Industry feels Insistence on a Exclusionary USFDA certification requirement is a grossly discriminatory clause

Domestic medical device industry has urged the Centre and States to do away with the insistence on USFDA approval in tendering process for public healthcare system and to replace it with more democratic options to eliminate discrimination against domestic manufacturers and to catalyze ‘Make in India' mission.

"Insistence on a Exclusionary USFDA certification requirement is a grossly discriminatory clause 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 domestic manufacturers and manufacturers from other countries from bidding and hiking up the healthcare costs," said Mr Rajiv Nath.

"No other country insists on only one certification and that also USA FDA and all major countries have their own domestic or alternate international certification e.g. Canada has CDMAS , Australia has TGA and Europe has CE. We have very competent manufacturers with European Certification or CE Mark Or it could be ISO 13485 certification from a reputed, competent and accredited Certification Body. USFDA could be an alternate option but why this insistence on only USFDA," added Mr Nath.

"This insistence of US FDA Certification by reputed Indian Government Institutions like AIIMS and PGI Chandigarh, seriously undermines the credibility of our own Regulators. It also allows dumping of outdated products in India just because they are USFDA approved and denies the patients access to latest technologies offered by Indian Manufacturers" said Mr Gurmit Singh Chugh, MD, Translumina Therapeutics, manufacturer of Drug Eluting Stents. "I have attained more respect and acceptability of our products in Europe and other developed markets due to our high quality and clinical data but are treated "second grade" in our own country just because we manufacture in India and its not USA FDA approved."


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