Desi Devices Get An Entry Into Indian Medical Tenders Finally

The desi medical devices makers can now make their way into various healthcare tenders floated by government hospitals across the country. The union ministry of health and family welfare has asked them to include and encourage domestic standards for procurement of medical devices in tender specifications by various health agencies.

On behalf of the ministry, additional secretary K B Agarwal has last week issued an advisory to all state governments and central health agencies to include medical devices approved by India’s drugs control authority Central Drug Standards Control Organization (CDSCO) for being considered for procurement and desist from insistence of US Food and Drug Administration approvals.

The advisory is being seen by the local industry, which has been asking for a level playing field between domestically produced medical devices and imports, as a much needed move to usher in price parity and also to encourage domestic manufacturing of medical devices. India, which has recently started manufacturing various medical devices, mostly low-end products, is still highly import-dependent for medical devices. Thus, hospitals and other healthcare institutions in the public sector insist for US FDA certification while procuring products from suppliers, who are predominantly global companies.

The government move now could reduce this humungous import dependency and bring down overall healthcare cost for common citizens, say the domestic industry.

“This advisory will certainly help create a level playing field between domestically produced medical devices and imports,” said Rajiv Nath, forum coordinator at Association of Indian Medical Industry (AIMED).

“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,” he added.

So far, may be due to legacy reasons, healthcare tenders by central and state health agencies have typically insisted on US FDA certifications to qualify for procurement. This has created a big disadvantage for domestic manufacturers. The tenders often do not consider alternative options such as ISO 13485 certification also.

However, the government advisory has now stated that denial of fair chance to the domestic manufacturers to compete in such procurements not only impedes competition, but also affects the government’s much touted ‘Make in India’ effort.

According to AIMED, the insistence of US FDA certification by reputed central and state government health institutions had seriously undermined the credibility of Indian regulators.

Currently, no other country in the world insists on only one certification source and that also USA FDA exclusively. All major countries have their own domestic or alternate international certification e.g. Canada has CDMAS, Australia has TGA and Europe has CE.

“India too have very competent manufacturers with CDSCO mfg license or European Certification of CE Mark or with credible ISO 13485 certification and the recently introduced ICMED 13485 certification by QCI ,” claims 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 AIMED’s Nath.

The ministry has in its advisory recommended that the states and union territories may 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. It also states that the technical specifications designed by the Ministry of health and family welfare and National Health Systems Resource Centre (NHSRC) may as far as possible be used for all procurements in future to ensure uniformity.