For monitoring of price movement of notified medical devices as drugs under DPCO, 2013, the National Pharmaceutical Pricing Authority (NPPA) has asked the manufacturers and importers of medical devices in the country to urgently produce a slew of documents to examine the extend of price variations of medical devices in the domestic market.
The NPPA's knee-jerk action in this regard comes in the wake of recent media reports that the prices of medical devices regulated as drugs under the Drugs and Cosmetics Act and Rules thereunder are sold at exorbitant prices with high profit or trade margins, particularly the prices of cardiac stents, drug eluting stents, orthopaedic implants, etc. There were also reports in the media that the prices of such medical devices notified as drugs have increased significantly during the recent past.
“In this regard it has been decided to seek the following information/documents in order to examine price variation, if any, in respect of notified medical device manufactured/imported/marketed by the company”, the NPPA said. The documents include product specification with brief description/literature for different types of notified medical devices manufactured/imported by the company; a copy of the current price list in Form-V under provision of DPCO, 2013; and details of price revision carried out during the last two years for each type of medical device.
The NPPA has issued letters to all concerned manufacturers/importers including Abbott Healthcare, Boston Scientific India, Zimmer India, Edwards Life Sciences, Johnson & Johnson, India Medtronic Corporate, B Braun Medical India, 3M India, Harsoria Healthcare and Roche Products India.