Keen to ensure a level playing ground for the domestic medical devices manufacturers, experts raised strong objection with the Centre on a recent technical bid specification floated by the government for various medical equipments under its different departments. Industry wants the Centre to modify these objectionable and exclusionary tender specifications that clearly stands as a threat to the growth of the sector.

It has come to notice that government departments like radiology, anesthesia, neonatology, paediatries, biochemistry, oxygen gas supply, biomedical waste etc. are favouring MNC companies over domestic players by adding US FDA restrictive clause specification for bids. The Association of Indian Medical Device Industry (AIMED) pointed out that all the tenders have discriminatory clause of quality certification requirements by USF DA and EU CE approved certification for equipment as well as for the reagents supply of hospital furniture, various medical equipment.

Industry strongly believes that this particular specification is discriminating and against interest of the Indian manufacturers, as manufacturers not having this certificate, which is beneficial only if doing business in USA, will be disqualified from the bid. The said specification is also against the spirit of prime minister’s make in India initiatives, the association stated.

Rajiv Nath, forum coordinator, AIMED said, “Rather than having a US FDA restrictive clause, we urge the government to consider amending technical specifications and add ISO 13485/CE/ICMED 13485 certifications along with US FDA as alternatives so that the bid can become non restrictive. If the requirement is for either one of the certifications, then manufacturers from across the globe will be free to participate in this tender, and not just the American manufacturers, opening up more competitive bids. Most importantly we urge the Centre to support the domestic industry by considering for all it’s tenders a 15 per cent price benefit for Indian origin goods, as done for world bank funded tenders under a buy Indian policy,” stressed Nath.

He further added that the government should also take pro active measure to bring in added weightage for better and longer duration of availability of maintenance staff and spare parts from manufacturers located in India. This measures he assured will offer equal opportunity to all potential participants who are competent in all other aspects.