Regulation for Prices of Medical Devices

As per section 3(b) of the Drugs and Cosmetics Act, 1940, the notified devices are presently regulated as drugs. Presently, 14 categories of medical devices have been notified. The pricing of drugs including notified devices is regulated by the National Pharmaceutical Pricing Authority (NPPA) under the Department of Pharmaceuticals and that Department has informed that presently ceiling prices of two devices have been fixed under the provisions of the Drugs Price Control Order (DPCO), 2013. The remaining medical devices are categorized as non-scheduled formulations under the DPCO, 2013 and their price has not been fixed. However, the DPCO, 2013 also provides for monitoring the price of non-scheduled formulations by ensuring that the increase in Maximum Retail Price (MRP) of non-scheduled medical devices is not more than 10% of the MRP prevalent during preceding 12 months.

The NPPA monitors/ regulates the prices of drugs and medical devices and also reviews the same in consultation with the manufacturers/ importers.

The Health Minister, Shri J P Nadda stated this in a written reply in the Rajya Sabha here today.