Stents manufactured in India are as good as those manufactured by foreign brands. Data from a decade-long study on patient safety and efficacy of drug-eluting stents (DES) has suggested that when it comes to clinical outcomes, there are no significant differences between a stent manufactured in India, and a leading foreign brand.
The results of this clinical trial called “ISAR-TEST 4” were presented by German cardiologists at the American Heart Association Scientific Sessions at Chicago this week, and have been published in the medical journal, Circulation.
The data will prove to be a shot in the arm for those who have been arguing in favour of price control on medical devices.
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Last February, the National Pharmaceutical Pricing Authority had capped the prices of coronary stents.
The move led to a huge debate over the issue of quality—cheaper, locally manufactured stents would mean “low quality”—and foreign medical device giants had moved the NPPA to withdraw their product from the market.
Those arguing in favour of price control, including the former NPPA chairman, Bhupendra Singh, have been citing studies that suggest expensive stents manufactured by prominent MNCs did not necessarily translate into better clinical outcomes.
According to the ISAR TEST 4 data, at 10 years, Yukon Choice PC (Indian stent) and the USFDA approved ‘Xience’ stent—both new generation drug-eluting stents—show significantly better results than an early generation drug-eluting stent.
“Not only does this data prove the long term efficacy and safety of DES, but it also gives a boost for the long-term success of the procedure of angioplasty after the launch of DES”, Dr Sebastian Kufner, Associate Professor of Cardiology, German Heart Centre, Munich, Germany, said in a press statement by Translumina, the manufacturer of Yukon Choice PC. Kufner had presented the data at the American Heart Association Scientific Session in Chicago.
“It’s encouraging to see Indian companies making these strides. They are accepted in several developed countries, but there are high trust issues in India. The strength of the study lies in showing the non-inferiority [of the Indian stent] over an extended follow up period of ten years,” said Malini Aisola, co-convenor, All India Drug Action Network.
