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PRICE CONTROL ON STENTS

P A Francis
Wednesday, January 04, 2017, 08:00 Hrs  [IST]

Last month the Department of Pharmaceuticals issued an order placing cardiac stents of all makes under price control. The long awaited decision of the Department allows the National Pharmaceutical Pricing Authority to fix prices for this life saving medical devices for the first time in the country. The order covers entire class of these products including drug eluting and biodegradable stents. NPPA is expected to fix the ceiling prices for the stents within a period of 60 days from the date of the order. The order comes at a time when the second hearing of a public interest litigation in the Delhi High Court seeking fixing a ceiling price and MRP for cardiac stents. As a step towards regulating prices of medical devices, the health ministry already had included cardiac stents in the National List of Essential Medicines in July last year. This decision was on the basis of the recommendation of an expert panel to place coronary stents in the NLEM as they are life saving products. The government has been contemplating to bring some price regulation on critical medical devices from 2014 in the context of repeated complaints of overcharging of these products by international companies. They have been freely importing and selling cardiac stents either directly or through their agents at exorbitant prices and making huge profits with the support of hospital managements and medical professionals. Only about 30 per cent of this class of products are indigenously produced.

Now the move to bring price control on cardiac stents and other medical devices is being opposed by the industry bodies representing both global and domestic companies. They threaten that such control on prices of these products could ultimately lead to a halt of launching of new and advanced products in the Indian market. Such a response from stent suppliers is not totally unexpected. The government should not get worried about such reactions from these companies and should go ahead with its plan. Apart from regulating prices of medical devices, there is a need to bring stringent quality assurance on their manufacture and import. Most of the units engaged in the manufacture of medical devices in India are small and do not follow GMP voluntarily and there are no specified standards laid down by the authorities for the materials used. There has been several complaints of malfunctioning of medical devices supplied by both Indian companies and MNCs from various parts of the country. Adverse events of even critical medical devices are not being monitored in the country. The health ministry’s decision to come out with a Materio-Vigilance Programme of India (MvPI) last year is with the aim to ensure safety of medical devices used in the country. Collection of safety data of these products in a systematic manner is extremely important for taking regulatory decisions and actions on the use of medical devices by the health authorities.

 

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