Question : Prices of Medical Devices

(a) whether the prices of medical devices like cardiac / eluting stents and implants are regulated / fixed by the Government;
(b) if so, the details thereof indicating the name of these devices and if not, the reasons therefor;
(c) whether the Government is aware that exorbitant prices of these devices are being charged from the consumers; and
(d) if so, the reaction of the Government thereto and the remedial measures taken / being taken by the Government / National Pharmaceutical Pricing Authority to check /control/fixed/reduce the prices of medical devices?

MINISTER OF STATE IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI HANSRAJ GANGARAM AHIR)
(a) to (d):Cardiac Stents / Drug Eluting Stents and Orthopedic Implants are notified as ‘drugs’ under section 3(b) (iv) of the Drugs & Cosmetics Act, 1940 and Rules made thereunder. These devices are not included in the National List of Essential Medicines (NLEM) 2011 which is incorporated in the Schedule-I to the Drugs (Price Control) Order, (DPCO) 2013 for the purpose of price control. Accordingly, Cardiac Stents / Drug Eluting Stents and Orthopedic Implants fall under non-scheduled category under DPCO, 2013 and as such no ceiling price has been fixed for these devices.
NPPA had asked the manufacturers / distributors of the medical devices, regulated as drugs, to provide information for monitoring of price movement as non-scheduled formulations under DPCO, 2013. As provided in the said order, no manufacturer / importer / distributor is allowed to increase the MRP of a non-scheduled drug more than ten percent of MRP during preceding twelve months.
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