Import of medical devices from US on the rise; here's all you need to know

Even as medical device makers in America allege the regulatory environment in India has hindered the growth of their export, the data suggests otherwise. From Rs 61.5 billion in 2014-15, import of medical devices from the US was Rs 74.2 bn in 2017-18. 

India imports around 80 per cent of its medical devices’ requirement and a fourth of that comes from the US. The overall medical devices market in India is estimated to be Rs 640 bn. 

In the past couple of years, the US-India Business Council and the Advanced Medical Technology Association (AdvaMed) have alleged that price controls in India act as a barrier. 

AdvaMed represents global majors Boston Scientific Corporation, Medtronic, BD, Apple, Abbott and others. It had opposed the price cap on coronary stents and knee implants imposed last year. 
The domestic medical devices industry says Indian regulations are not entirely preferential for home manufacturers.

"There is no separate policy in place for Indian manufacturers under the Make in India policy. Unlike China, there is also no policy discrimination here. The National Pharmaceutical Pricing Authority applies for everyone,” said Ganesh Sabat, chief executive officer of SMT, this country’s largest maker of cardiac stents. 

In fact, for a number of devices (examples are  multiparameter monitors, defibrillators and transport monitors), the Government of India insists on having the US Food and Drug Administration certification. Of the 442 devices procured under the Pradhan Mantri Swasthya Suraksha Yojana, the US FDA measure was needed for 23. 

The ministry of health & family welfare had in a circular issued this February stated that for ‘quality reasons’, doctors would be free to insist on the FDA certification.

Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry, says in contrast, the US government bars Indian manufacturers from bidding for any tender there.

A senior commerce ministry official said medical devices are not in the tentative list of items for which the US wants a discussion when commerce and industry minister Suresh Prabhu visits the US next week for trade talks. 

The basic customs duty for various categories of medical device import is 7.5 per cent. 

The domestic industry has repeatedly said this is stoo low and does not encourage health care providers or companies on home sourcing. 

“We have received several representations from industry associations who say it is cheaper to import the goods than buy from Indian firms. We are assessing the hit to the industry but no duty hikes are expected as of now,” a customs department official said.

Import in the category rose from $1.35 bn in 2016-17 to $1.52 bn in 2017-18, a 12 per cent rise. 

The increase had been only one per cent in the previous year. The share of the US in overall import was 27 per cent in 2014-15; it had come down to 25 per cent in 2017-18. 

“It is strange that companies that sell stents in Italy for less than Rs 20,000 and less than Rs 40,000 in Germany, are crying foul in India where they price the stents at Rs 30,000 each,” said Sabat.