When India began imposing price cuts of between 75% and 85% on cardiac stents in February 2017, many industry watchers expected global medical device makers to withdraw from the market altogether.
The logic was simple. As US device makers such as Boston Scientific and Medtronic mainly supplied the niche segments of India’s stent market, selling those value-added products at lower prices simply made no business sense.
Price caps ignore differences in quality and value-added production, and in some cases, the device makers must sell their product at a loss.
Some experts even worried about the future supply of critical devices for patients in the second-most populous nation as the price controls on stents were seen as a precursor to curbs on the prices of other devices ranging from catheters to orthopaedic implants.
Fast forward to 2022, and all of it seems like much ado about nothing.
The device makers seem to have made peace with the fact that India is too vital a market for them to shun, with some even finding ways to keep price regulators happy.
“We cannot ignore India as a market. But we have to evaluate how to keep in mind business interests. We don't think we will launch stents that are totally new, in India, as it is not viable. But once that product has been in the market for a few years and newer products are launched, we will look to bring it to India,” an official at Boston Scientific said on condition of anonymity citing lack of authorisation to speak with the press.
Some medical device makers have gone a step further and even decided to invest more in innovation here with an eye on making India a major research and development hub.
For instance, Boston Scientific brought back Synergy, a stent that was withdrawn after the price caps were introduced, and recently inaugurated its second R&D facility in India, years after its first facility in Gurugram became operational.
"This second R&D Centre reinforces our commitment to contribute meaningfully to the innovation landscape for medical devices in India,” Boston Scientific India's managing director, Manoj Madhavan, said while inaugurating the facility in Pune.
The Indian medical devices market was worth Rs. 75,611 crore ($10.36 billion) in 2020, according to the India Brand Equity Foundation, a government export promotion agency.
Medtronic did not respond to DH's queries and Boston Scientific declined to comment on its strategy for India.
“India has so many talented people who are capable of research and development. Plus, there is not much capex involved in R&D. For instance, we do not need a manufacturing facility,” a senior official from Boston Scientific told DH on condition of anonymity.
Boston Scientific has commercialised five catheters that were designed in India and has also secured patents for a number of products in the last few years, the senior official from Boston Scientific told DH.
Meanwhile, Medtronic opened its largest R&D centre outside the United States in Hyderabad last year. DH could not find out the status of its stents in India.
Abbott, Boston Scientific and Medtronic had asked for better pricing for their latest stents claiming superiority. However, studies including those by TCTMD – a provider of in-depth coverage of cardiovascular disease research and practice – had noted that proof of non-inferiority did not mean those stents were superior in efficacy.
A 2021 study by TCTMD said that there was no real advantage even with stents like Synergy. The report said, "There was no added risk of acute stent thrombosis with Synergy, but also no real advantage when compared with leading DES.” A DES or drug-eluting stent is a metal mesh coil that helps in reopening a blocked coronary artery and keeps it open.
One senior official from Medtronic told DH that one of the problems in India was scalability, adding that the market did not account for more than 2% of the total revenue of the multinational device companies that sell their products here.
“Ideally, it should have over 10% for the population,” that person told DH on condition of anonymity.
Some experts sided with the companies and said the price controls aimed at supporting India’s domestic industry made little sense.
"Companies don't plan for one year or two years. They plan much ahead. For a robust investment climate, it is important to provide a predictable and enabling environment (such as regulatory and pricing issues). For the innovative medical devices industry, the government should look at encouraging R&D in India rather than (having) a disproportionate focus on only “Make in India” and local content,” said Krishna Sarma, the founder and managing partner of Delhi-based Corporate Law Group.
“The latter can be required over a period of time while not stymying the access to new and cutting-edge medical devices to Indian patients,” Sarma added.
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