Union government should mandate the use of only high quality stents manufactured by Indian companies across all hospitals in India. Such a move would give local stent manufacturers headway into the Indian stent market which is currently dominated by global companies, said Ganesh P Sabat, CEO, Sahajanand Medical Technologies (SMT).

For instance, China permits stents produced by its domestic companies to be used by all its hospitals. In Japan too, its cardiologists opt only for Japanese technology stents. If our government wants to promote the medical devices sector, it should only prefer high quality local stents. Instead the reality is that government tenders for stents are entertained only if bidders are US FDA certified. Therefore, our government needs to define the quality standard for Indian stents. DCGI should approve the clinical data of drug eluting stents (DES) on Indian patients. When the government sees medical devices as a sunrise industry with considerable growth potential to become a global manufacturing hub, it should study the business model of this sector from countries like Ireland and US, he said.

Indian stent manufacturers like SMT are gearing up to reinstate their quality and pricing over an US FDA approved product. It is first company in the country to conduct randomized clinical trials (RCT) of its Supraflex stents in Europe, said Sabat adding that that it will be only a matter of time to prove the credibility of its stents in India.

The one-year Talent RCT for SMT’s stent on 1430 patients across 27 centres in 7 countries is at the behest of the Cardiologists Society of India which requires a randomised study to use the stent on patients in India. The randomization is pre-decided by an external agency, ECRI and the clinical research organisation is Netherlands’ Cardialysis, a cardiology trial specialist. For the study, SMT is associated with leading global interventional cardiologists like Dr. Patrick W. Serruys and Prof. Antonio Colombo.

Although SMT has planned for a US FDA certification, it is the first to bag CE approval on biodegradable polymer DES with a study on 8,000 patients in India reported in leading journals. Being a company backed by science, we will proceed systematically to prove it to the world on the clinical efficacy of our stent, Sabat told Pharmabiz.

The company has a manufacturing facility at the Sachin Industrial Area in Surat which has approvals from around 60 countries and undergoing an annual 10 to 12 global audits. Going forward, SMT is looking for a second facility to manufacture one million stents annually from the current 2,00,000 stents a year. It recently, opened an R&D facility in Ireland where its scientists will design its future products that include other medical devices.

According to Sabat, India imports almost 80-90 percent of the medical devices and government needs to reverse the same. This would be possible only if government funds projects and also opts for only high quality and affordable stents manufactured by Indian companies. PEs and VCs are also supportive to the medical devices sector as SMT received a fund infusion from Samara Capital for its R&D, new manufacturing facility and product diversification, he said.