The Medical Technology Association of India mentioned that broad-brush criteria for procurement of devices will only lead to manufacture of low quality products in the country.

Medical Technology Association of India (MTaI), which represents leading research-based medical technology companies with significant investments in Manufacturing in India, on 26^th March said broad-brush criteria for public procurement will cause proliferation of manufacturing of low quality products in India while high quality components retain their axis abroad. At present, India has got adequate manufacturing capabilities for products like syringes, cannulae, stop cocks, extension lines, blood bags, dressings, hospital furniture, and suction machines, but lacks the desired ecosystem for devices like heartlung machines, pacemakers, complex catheters and others, a MTaI statement here today said.

“Unlike several other sectors, medical devices are comprised of thousands of very varied products in engineering and design complexity. A uniform 25-50% local content ask, preceding any meaningful scaling up of the missing sophisticated component ecosystem will create a risk of ‘garage manufacturing’ with low cost – low quality Chinese knocked-down kits based assembly.” MTaI Director Probir Das said.

“This is compounded by the fact that India’s medical devices regulatory regime is new, the rules and their implementation is nascent, and the country’s materio-vigilance programme will take time to scale up. Any preferential provisions for public procurement at this stage must only be limited to products where India has existing manufacturing capacity. The capacity should be validated by credible third parties like PWC & KPMG,” he added.

MTaI Chairman and Director General Pavan Choudary said MTaI members applaud the government’s Ayushman Bharat initiative and are committed to support all initiatives that ensure growth of the sector. “But somewhere there is an over-simplification of a complex problem. Measures like price capping and preferential market access without taking into account the complexity of the sector are going to create obstacles in realization of ‘Make in India’ goal,”Mr. Choudary said.

“This year the FDI in medical devices was clearly pipped to cross USD 1 billion, thanks to this government’s move of bringing it on the automatic route. However, it has dipped to just USD 184million. Why did the FDI lose it trajectory of growth is what the government should ask,” he added.