Clinical Trials Certify Global Credentials Of Indian Stents

Cardiac ailments account for the largest number of deaths in India and an estimated 30 million people are affected by it. Around two lakh cardiac surgeries are executed in this country every year.

In India, heart disease deaths have risen by 34 per cent in the course of 26 years. Thankfully, more patients now benefit from advanced technology-driven interventions to deal with cardiac complications. This is mainly due to advanced innovation in stents over the last few years, proving quality healthcare outcomes.

About seven lakh stents were used in India last year. One important development that has happened in the interim is price parity brought by the government’s regulatory agency, the National Pharmaceutical Pricing Authority (NPPA), with globally prevalent costs of cardiac stents.

This has rendered the stent game even more competitive, as NPPA has succeeded in not only bringing about a much-needed respite in the sector by controlling the pricing of drug-eluting stents (DES) and bare metal stents but has also bolstered domestic Indian companies to make their footprints visible vis-à-vis their multinational counterparts with equally competitive and non-inferior stents. That the multinational companies choose to dub the NPPA move ‘predatory pricing’ is another story altogether.

Conservative estimates put the medical devices retail market in India at between $9.3 billion and $10.8 billion. In fact, India relies primarily on imports to supply and provide for her healthcare system, supplementing and filling it with medical technologies of the day.

The manufacturing of drug-eluting stents has gone through many highs and lows. The import-dependent stent industry for over two decades was dominated by large American multinational companies until a few domestic manufacturers started making cardiovascular implants with equally advanced features and quality.

It was being anticipated that indigenous products would contribute to lowered dependence on imported products.  However, the challenge is that medical devices regulation in India only applies to certain product categories.

To compound matters further, India’s underdeveloped regulatory framework is a significant obstacle for foreign manufacturers of regulated device types.  Also, the weak rupee makes it difficult for Indian medical device companies to remain profitable in this market, particularly when competing with low-cost Chinese products.

Like India’s emergence as the world’s pharmacy, Indian medical devices sector too have stepped up its technological prowess. A randomised clinical trial ‘TALENT’ study, which established that Indian drug-eluting stent is at par with other globally available variants, is a feather in the cap of domestic medical devices manufacturers battling it out with assorted international players in a mixed market space.

The “TALENT” study published in The Lancet, was validated and refereed by the European Cardiovascular Research Institute (ECRI) aimed at certifying the global credentials of the Indian manufactured stents.

The trial study, behind ‘TALENT’, was conducted in seven countries, UK, Netherlands, Poland, Spain, Italy, Hungary and Bulgaria across 23 globally renowned centres with a sample size of 1,435 patients.

Stents, once put inside patients, lowers the risk of the artery re-narrowing and these modern state-of-the-art drug-eluting stents are coated with bespoke medicines, unlike basic metal stents, that help lower the chance of renewed artery blockages.

In the Indian context, this not only means a significant reduction in re-procedures – that itself is a trauma and cost-intensive for any individual – but also implies a huge saving in stent prices and procedure costs that runs annually into crores.

The successful outcome of these clinical trials proves that Indian stents are at par with the ones produced by multinational companies. This rests the case about the quality of Indian stents.

These internationally benchmarked Indian stents, now available under an affordable cost mandated by NPPA, not only helps the accessibility of cardiac care for Indian patients, but also aligns under the Ayushman Bharat healthcare umbrella.  – DNA India

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