The capping of the stent prices has changed the equations of the Indian Healthcare Market. With India being the largest market for coronary stents, this has already created ripples in the global healthcare market.
I have grown up watching consumer awareness advertisements during the live telecast of cricket matches that emphasize on purchasing goods and commodities after examining the MRP (maximum retail price). There were over thousand people who paid 1,20, 000 or more for a commodity of 20,000 for years and they never complained. They never cared to ask for the MRP and maybe they had, but no one ever made an endeavor to cap the price of this life saving medical device. However, Birender Sangwan probed into the matter. He is a lawyer by profession. In an interview with the Quartz, he said, “I was always scared of hospitals. I still get dizzy and feel like vomiting when I go to hospitals.” Sangwan is the man behind the radical change that swept through the over 7 billion dollars healthcare industry in India. He is the one to be blamed for Abbot withdrawing it’s remarkable bioresorbable stent ‘Absorb’ priced at 1.9 lakh INR (2800$). However, his endeavors have been hailed by the people in general, as his PIL filed in December 2016 led to over 75% reduction in stent prices.
A stent is a small mesh tube that is used to treat narrow or weak arteries. Stents are made of stainless steel, Nitinol, Cobalt-Chromium alloys or biomaterials like Poly L-Lactic Acid (PLAA). According to the research article by Rani K. Hasan et al. (Division of Cardiology, Johns Hopkins University) in American Journal of Cardiovascular Disease, South Asians are one of the highest risk ethnic groups for development of Coronary Artery Diseases (CAD). This may be attributed to their smaller coronary artery diameter than the Caucasians. Considering the above fact and with over 1.3 billion population, India becomes the largest market for coronary stents, estimating over $500 million. So, the recent move by NPPA is likely to create a ripple in the global healthcare market and the implications are quite conspicuous.
Even after the direction from Hon’ble High Court of Delhi, the core committee that appended 106 medicines and medical devices to the National List of Essential Medicine (NLEM) in November 2015, overlooked stents. On July 19, 2016, a plea was moved in the Delhi High Court by Mr. Sangwan and stent was included in NLEM. Mr. Sangwan was not complacent. He filed another petition asking for capping the stent prices in December 2016.He also sought for the prompt availability of stents at medical stores. Finally, in February 2017, much to the respite of the general public, Government capped the stent prices.
Contemporary Indian Stent Market
Currently, the prices of the coronary stents have been capped at 29,600 (USD $450) for Drug-Eluting stent and 7,260 (USD $110) for bare metal stents. They used to be sold at around 1,20,000 (USD $1900) and 45,000 respectively. It is astonishing to know that the margin of profit, which gets portioned out between doctors, hospital’s margin, medical representatives, dealers and the manufacturing company, is roughly over 700%. Before March 2017, more than 70% of the stents in Indian market were imported.
I was working on my undergraduate project on the design of tapered stents in collaboration with IMS (BHU). From my interactions with doctors and technicians over there, I realized that they usually offer two choices to the patients, Indian and American stents. However, from the Zauba import data, I found out that more than 70% of those imported stents are from Ireland and less than 10% are actually imported from the USA. Nevertheless, it is inferential from the fact that the top 15 of the 20 multinational healthcare companies have their headquarters in Ireland. In India, Surat is the manufacturing hub of low-cost cardiovascular stents in India. In fact, 9 out of the 11 Indian stent companies manufacturing these tiny tubes are based in Surat and its neighboring areas. After the move by NPPA, the indigenous stents have seen a boost in demand. Indian stents, be it bare metal stents or drug-eluting stents, are usually cheaper than the imported stents. Post capping, there has been a marked dip in the stents imported to India. The 3 leaders in medical device development, Abbot, Medtronic and Boston Scientific have filed applications with Drug Pricing Regulator to withdraw new generation stents. In May 2017, a government panel dismissed the claims of Boston Scientific to increase the price cap for Drug-Eluting Stents citing ‘no major innovation in Boston Scientific’s stent’. The company had asked to raise the price cap to 75000 (USD $1160). Abbott wants to withdraw the ‘Absorb’ and ‘Alpine’ stents citing ‘commercial instability’. However, bioresorbable stents called ‘Absorb’ accounts for only 1% of the total stent sale in India.
Technology v/s Affordability and the reality
Multinational companies invest huge fortunes in their R&D wings. According to Dr Om Shankar, Department of Cardiology, IMS (BHU), “Currently, there are no Indian companies that are involved in tapered stent manufacturing. Tapered stents have added benefits than the uniform diameter stents. The human arteries are anthropomorphically tapered.” As I dived into the state-of-the-art research in stents, from the documentation of various companies, I found that there are many stents which have not been tested for use on particular groups of patients like pregnant women, patients with coagulopathies etc. Further, manufacturing of stents from biomaterials is still at an embryonic stage in India. You would never want the metallic tubes to be there forever. Metal stents not only make future coronary artery bypass graft (CABG) difficult but also prevent investigation of the patient under MRI and other diagnostic technologies that use X-ray. Further, the stents are subjected to ‘restenosis’ (a medical term meaning recurrence of blockage at the same arterial site). Even after angiography, patients are still advised to take medicines as part of antiplatelet therapy to prevent ‘restenosis’. Current research in stents is focusing on dealing with arterial bifurcations and Indian stent manufacturers are far away from these cutting-edge research. So, the newer generation of stents is expected to be better and costly.
The move by NCPP has become a harbinger of a new wave of respite for the mango people (common man) in a country with less than 25% of the population having a health insurance, but at the same time, it is a challenge to the quality of stents and the technology development. This has already rewired the supply chain network of stents in India. Neighbouring countries like Nepal and Sri Lanka are likely to cash on from elite Indian class who can afford a medical tourism for getting new generation stent implant. Moreover, Indian Medical Association (IMA) doesn’t prevent an Indian doctor to perform surgeries abroad. So, this opens up new avenues for several healthcare consultancies to help people do implants outside India while they can still consult their doctors in India. Further, post-capping of price, there has been frequent news of hospitals hiking their procedural costs.
Now, the government is considering bringing more medical devices like catheters, orthopedic implants under the price control by including them in NLEM. The medical device market in India is over $7 billion USD and more than 75% of the devices are imported. I fear of a dry competition without the powerful impulse of technological innovation and this may worsen the scenario in the coming days. The capping of stent price was meant for the affordability of the common mass, who don’t use the newer generation of stents. The Indian stent market could have been more open if NPPA had come up with another price cap for the newer generation of stents. However, affordability, medical ethics and technological innovation, when churned together, is an intriguing topic. Companies, distributors and hospitals found violating NPPA’s order by overcharging patients for the devices would be penalized or blacklisted, Minister of Chemicals and Fertilisers Ananth Kumar had earlier said. At least, it is unequivocal that the move by NPPA is noble if implemented rigorously.