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Mumbai: A host of domestic companies — manufacturing life-saving medical devices including pacemakers, cardiac stents, ventilators, electro-surgical units — are facing the heat in the wake of government hospitals and institutions imposing restrictive conditions in procurement tenders. Domestic medical device industry feels public hospitals and institutions across the country are indulging in discriminatory practices against them, while favouring MNCs in the bidding process. In the latest example, U N Mehta Institute of Cardiology & Research Centre, one of the largest government hospitals in the Prime Ministers home state, Gujarat, has a tender for supply of life-saving cardiac stents that stipulates the product should be certified by all three regulatory agencies — US Food and Drug Administration, European Medical Device Directives (CE marked) and Indias drug controller general. The tender closed on October 3. Overall the medical devices industry is valued at Rs 60,000 crore, with roughly one-third comprising institutional procurement by the state and central government. Ironically this comes at a time, when the government has been promoting initiatives like Make in India and Start up India, to spur indigenous manufacturing and innovation. A list by industry body Association of Indian Medical Device Industry (AiMeD) has tenders floated by over 20 public institutions including state medical corporations, and hospitals which have stipulated restrictive clauses, including S N Medical College (Agra), Sanjay Gandhi Post Graduate Institute of Medical Sciences (Lucknow), All India Institute of Medical Sciences (Rishikesh), Base Hospital (Delhi) for supply of wide-ranging devices like pacemakers, cardiac, laproscopy and neuro instruments, intravenous therapeutic consumables, ventilators, and even hospital beds. AiMeD forum coordinator Rajiv Nath told TOI, Its unfortunate when government-owned-and-financed hospitals discriminate against Indian manufacturers, instead of giving a preference to them. This is also in complete violation of the recent public purchase order by DIPP, and a circular from ministry of health, with tenders issued by public healthcare facilities run by Defence, AIIMS and even state governments (U N Mehta Hospital, Gujarat) continuing to specify compliance to both USFDA and CE certification. Its ironical that to access our own market, we need to seek third-country regulatory approvals or certifications. The government should not finance such discriminatory tenders. Other countries like US have a Buy American policy, and follow the Trade Agreements Act which debar foreign (Indian) manufacturers and exporters to sell to US Defence and bid for public procurement tenders. The public purchase order gives preference to domestic suppliers for government purchase by giving them the option to match the lowest bid by an overseas company, and opt for 50% share, and specifying CE or US FDA clause is contravention of this order, he added. Requesting U N Mehta Institute to amend the technical specifications, AiMeD has suggested quality certification (including ISO/CE/ICMED) to be considered as an alternative to that of USFDA, to ensure bids become non-restrictive and competitive, and not be cornered by US companies alone. We are not questioning the quality specification, but the need for mandatory certification both from USFDA and Europe, for selling in our home market, Nath told TOI, adding the discrimination (against domestic industry) has been practised for long. To quell the quality argument, the industry is upgrading to ICMED, a certification by Quality Council of India, on a par with international regulatory requirements, like European CE. At present, only a handful of domestic companies have obtained ICMED certification, with over 50 companies in the process of getting it. The communication adds domestic industry may be supported by considering a 15% price benefit for Indian-origin goods with over 50% domestic content (as done for World Bank-funded tenders) under a Buy Indian Policy, and added 5% weightage given for ICMED certification. |
