The medical device industry has opposed the Centre’s plan of mandatory local purchase in some case 50% of the total requirement – of a large number of medical devices while procuring these instruments for government hospitals and clinics.
The proposal, mooted by the Department of Pharmaceuticals earlier this month with an underlying objective to boost Make in India, was opposed by the multinational companies that import and sell their wares in India, citing quality issues.
Domestic manufacturers too were unhappy because no special incentive was offered to the locals to boost manufacturing of quality products.
According to the proposal, in public procurement, there should be 50% local content in medical disposables and consumables; 40% for implants and 25% for diagnostic reagents and in-vitro diagnostics. Moreover, 25% local content has been suggested for medical electronics, hospital equipment and surgical instruments too.
The mandatory local procurement would be applicable to contracts worth Rs 50 lakh or less, which would keep high-end imaging devices outside the purview of the proposal.
“With 50% local content clause, garage manufacturing will emerge automatically,” argued Pavan Choudary, chairman and director general of Medical Technology Association of India (MTaI), an industry lobby group largely comprising multinational companies who import medical devices in the Indian market.
Though many low-end medical devices and consumables like syringe, cannula and surgical gloves are produced in India, Choudary said complex instruments like pacemakers (for the heart) and central and arterial catheters were not manufactured in India.
The MTaI cited lack of quality control expertise in the Indian regulatory system to sniff out the chaff from the grains.
“Regulatory guidelines (on the medical device) are new and CDSCO is still on the quality control journey. It takes time to build up the competence,” said Probir Das, MTaI director and managing director of Terumo India Pvt Ltd.
The MTaI supported a cautious approach on the part of the government for patient safety whereas another industry association expressed its displeasure due to the absence of any incentive for the indigenous industry, which suffers from several handicaps to start with.
“The draft Preferential Market Access policy in its present form does not provide preferential pricing to Indian manufacturers, no incentives on maintaining and improving quality,” said Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry.
The medical device industry was under the government’s scanner because of the high price of several products. In the last two years, cardiac stents and knee implants were brought under price control in the same manner that is followed for essential drugs. (With DH)
