New Delhi: In a bid to promote affordable and more accessible indigenous drug eluting latest generation stents, Indian Council of Medical Research (ICMR) is going to undertake a comparative study of indigenous drug eluting latest generation stents and the US Food and Drugs Administration (FDA)-approved drug eluting stents.
According to ICMR, the study would help establish scientific data in support of domestic stent manufacturers and also help clinicians practicing in India to make informed decisions while choosing between the indigenous and standard FDA approved drug eluting stents as they remain wary of the standards adopted by Indian manufacturers in comparison to the US FDA and EU (European Union) approved devices.
ICMR aims to compare two latest generation Indian drug eluting stents with one FDA approved drug eluting stent through sponsored trial. It is planning to sponsor a randomized controlled, non-inferiority multi-centric clinical trial comparing the identified indigenous stents with a standard US FDA approved stent with the best outcomes data.
For this, it has invited Expression of Interest (EoI) from Indian stent manufacturing companies and FDA approved companies for participation in the randomized clinical stent trial during 2014-16. The intending stent manufacturing companies, both Indian and FDA approved, will be required to supply stents free of cost to the participating centres and support the implementation of the trial.
“Considering the need for development of indigenous technologies, products and to have reliable data about safety and efficacy ICMR plans to undertake the study. Technologies have to reach the people at an affordable cost without a compromise on safety and efficacy. It is very important in the era of evidence based medicine to generate good scientific evidence so that it can be stated that indigenous products are not only cost effective but also efficacious and are of equally good standards,” according to ICMR.
The high cost of stents manufactured by multinational companies has been a cause of concern in India. There are only few domestic players in the stent manufacturing sector with international players like Abbott, Boston Scientific and Medtronic ruling the market.
Lately, some Indian companies like Translumina Therapeutics, which manufactures a stent named Yukon Choice PC, has been giving tough competition to international players by providing the product at a cost almost half of a FDA-approved manufacturer device. But any official finding to support their commercial, academic and scientific claims were missing. This comparative study, implemented effectively, could be answer to their concerns.
Dr Vishwa Mohan Katoch, director general, ICMR, told India Medical Times, “The objective behind the comparative study is to establish scientific evidence that indigenous drug eluting stents are as robust as FDA approved. The debate is going on in the country in this regard for last two years over the price control of medical devices like stents. If we want our Indian companies to do well in the area and instil the confidence in them, an observation of this sort is need of the hour. Foreign companies already have studies and analysis in place, India needed to bring such a study too.”
“We are also considering to simultaneously review technical literature already published in this area. The whole point is why should the country pay for imported stents if equally superior quality stents are available from local manufacturers at comparatively much lower prices. By undertaking the study a documentary evidence would be put in place to strengthen the position of Indian stent manufacturers. This would bring innovation and also increase global competition,” added Dr Katoch.
It is to be noted that India has been making several attempts to improve healthcare access for its citizens, like introducing pricing measures for drugs and sale of generic drugs at low prices. Now, as can be observed in the last few months, the country is focusing on regulating the medical device industry.
In February, the union health ministry had slashed reimbursement rates for drug-eluting stents by more than 60 per cent, fixing Rs 25,000 as the standard rate, irrespective of the origin of the stent used.
The latest move to undertake the comparative study could give a much needed stimulus to the domestic stent industry and make the stents more affordable as the high cost of stents manufactured by multinational players has kept the life-saving device out of reach of many.
by Vidhi Rathee
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