News Update

Government action for price caps of medical devices starting from Stents to protect Consumers is welcomed by Consumer Groups and supported by Indian Manufacturers.



Medgate today Magazine

AiMeD supports Governments domestic medical devices manufacturers.move to finally put a cap on the MRP’s of Stents - Rajiv Nath , Forum Coordinator, AiMeD - Association of Indian Medical Devices industry , the apex body representing

We applaud the efforts of the health ministry to take this bold step to cap Prices of Stents -Bejon Misra, Founder - Patient Safety and Access Initiative of India Foundation

The long awaited move of Government to step in to control the high prices of cardiac Stents shall bring relief for many poor patients for whom the cost of affording a drug eluting Stent had become prohibitive. “ A correction and price regulation in this market was long overdue and AiMeD supports Governments move to finally put a cap on the MRP’s which shall ensure fair practices in this important sector which was plagued with exorbitant prices charged from ignorant helpless patients” said Mr Rajiv Nath ,Forum Coordinator , AIMeD - Association of Indian Medical Devices Industry, (the apex body representing domestic medical devices manufacturers).

Current Indian Market is around 5.50 lakh Stents per annum out of which more than 90% are Drug Eluting Stents (DES).The market is growing at a speed of around 15% every year and shall become the second largest market in the World after China by 2020. Drug Eluting Stents were launched in 2001 by US Multinational who ruled the market with more than 85% share until 2010 when Indian DES started getting acceptability. There was a general perception since last 10-15 years that that American Stents have better quality standards based on the clinical trials performed and thus they command a higher price. However, there are several Indian companies which have done extensive efforts to create Indian Drug Eluting Stents which have proven equivalent and even better than American DES in Large Clinical Studies(Randomised control trials where Indian DES is compared with American DES for its clinical performance and quality Standards). The clinical data of these Proven Indian DES with high quality standards have been audited and published by Top Journals of Cardiology worldwide.

“We applaud the efforts of the health ministry to take this bold step to cap Prices of Stents which will serve a larger patients interest.DES are life saving and patient have little knowledge to select the Stents. Moreover, the time given by the Physicians to the patients is very less since most of the time Cardiologists insist the relatives to take the decision regarding the choice of Stent while the patient is on table inside the Cath lab. We strongly believe that this move shall break the Industry-Doctor nexus and will force hospitals to be transparent with the prices of Stents.Also such surgeries and use of devices should also be used rationally and with proper due diligence on the treatment method.” Said Mr.Bejon Misra, Founder - Patient Safety and Access Initiative of India Foundation.

There is also a concerned voiced by many associations representing the multinational companies importing these devices that the low prices will curb innovation and shall deny Indian patients access to quality products from abroad.

“ The Indian companies like Translumina and Meril have huge capacities and have already achieved close to 20% market share within 5 years of their launch. Their DES have been proven non-inferior to their American counterparts in large Clinical studies performed in Europe. I have been using the Indian Stents from the last 8 years and have satisfactory results in my patients. I appeal to the Government to further support the “Make in India” idea of these high end devices which shall bring long term self reliance in this important sector which is currently dominated by imports.” Said Dr Animesh Mishra, HOD, Department of Cardiology, NEGRIMS Shillong and a member of NLEM(National List of essential medicine) core Committee on Stents which recommended this move.

The next step shall be the decision on the price by NPPA(National Pharmaceutical Pricing Authority) which shall submit its recommendation to department of Pharmaceuticals under Ministry of Chemicals and Fertilizers. “While we have been informed that Price Capping report submitted to NPPA does not follow the method of price capping as in case of drugs we recommend the NPPA to follow a scientific process to arrive at a fair MRP considering the fact that unlike pharmaceuticals, every Class III medical device like DES needs huge investment on R&D and Clinical trials. A knee-jerk price mechanism may be detrimental to the Industry” said Rajiv Nath. He explained,

Domestic and Foreign manufacturers are not the villains in this context as the hospitals dictate and drive the printed MRP of medical devices in their quests to cover their costs . All stakeholders need to have balanced expectations from each other .Bringing Stents under NLEM will stop this artificial inflation by hospitals . In fact other than consumers even the domestic manufacturers will gain from this Govt.'s move to protect consumers and for the medical profession the focus will shift to evaluating performance based quality parameters and value based competitiveness rather than being skewed in favour of better margins from higher pricing "said Nath

"There's a huge price disparity in stents and in absence of an industry wide consensus of a self regulatory mechanism we can understand the need for Government to step in to protect consumers from this huge price disparity and for using the provision of NLEM via the NPPA route as a short term measure to address this burning issue being raised at the Parliament and in the media repeatedly . It's a good move given the circumstances and we support it though we believe that there needs to be different price control mechanism other than DPCO for all medical devices as a long term measure as the DPCO does not adequately address disparity of prices of drugs effectively other than those brought under NLEM listing which could be overly restrictive at times. Said Dr Velu , Chairman of Trivitron.

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