Four of 10 stents used locally 'made in India'.
Malathy Iyer,TNN | May 25, 2015, 01.10 AM IST
MUMBAI: Mention stents, and an image of an imported medical device with a hefty price tag comes to mind. But the latest data from the Cardiological Society of India shows that a sizeable number of stents-tiny, mesh-like tubes that are used to open up narrowed diseased arteries - used across hospitals in 2014 carried the 'Make in India' label.
Almost four out of every 10 stents used in Indian hospitals carry a local tag, said the National Interventional Council (NIC) registry maintained by the CSI. "The Indian stents offer a price advantage," said a doctor. Only 396 out of the 624 cath labs (where stenting is carried out) across India report to the registry, but it provides the best insight into heart-care and disease patterns across the country.
"A total of 3,10,190 stents were reported to be used for 2,48,152 coronary interventions, an average of just over 1.2 per procedure," said Dr Praveen Chandra, a cardiologist from Medanta Medicity in Gurgaon who worked out the NIC data. His data shows that 40.5% of these 3.1 lakh stents were made by Indian companies, while three multinational companies enjoy 59.5% of the market share.
In recent times, stents have come to symbolize corruption in the Indian healthcare system; charges of overpricing are rampant. The Maharashtra Food & Drug Administration last week said that imported stents were sold to Indian patients at 700% more than the import cost: a stent with a landing price of Rs 25,000 costs Rs 1.55 lakh to the hospitalized patient.
The debate between imported versus Indian stent thus gains importance. Cardiologists say that Indian stents seem effective enough; they added that there is little to show in terms of scientific data.
Dr A B Mehta, director of cardiology from Jaslok Hospital, Peddar Road, said, "The Indian stents are not only cheaper but some of them have great specifications. The stents made by Meril, for instance, have less thickness than the imported ones and are hence quite popular."
But there are many doctors who don't use Indian stents because of the lack of academic work. "I have never used a stent that hasn't been thoroughly researched," said Dr Prafulla Kerkar, who heads the cardiology department of KEM Hospital in Parel. Even for the poor patients operated under the Maharashtra-government-run Rajeev Gandhi Arogya Yojana, he prefers to use an imported stent specially procured by the state government at the cost of Rs 23,000.
"A poor patient can never get what is considered the Iphone 6, but let us at least give him or her an Iphone 4 that has great amount of data and research behind it," he said. Stents, like smartphones, come with various upgrades and are named as 'generation 1', 'generation 2' and so on. The Maharashtra government procures drug-eluting stents costing between Rs 23,000 and Rs 28,000 for patients operated under its health schemes.
Senior cardiologist Dr Ashok Seth from Fortis Escorts Heart Institute in New Delhi said that he had conducted two studies on the efficacy of Indian stents. "Indian stents are no doubt good, but they are at best copies of the original stents," he said.
All medical devices and medicines need to pass through a clinical trial before being offered to patients. "However, the Indian stents only need to show safety in 100 patients to get regulatory approval. The imported stent, on the other hand, goes through clinical and safety trials as well as one-, two- and five-year follow-up studies," said Dr Seth. It is time Indian companies invested in research, he added.
All doctors whom TOI spoke to supported the idea of governmental regulation in pricing of stents, but they said the government should standardize safety and efficacy aspects as well. more