All medical devices shall be regulated by the government as drugs for quality control and price monitoring from April 1, 2020, the Ministry of Chemicals and Fertilizers said in a statement on Tuesday. The National Pharmaceutical Pricing Authority (NPPA) in its a notification on Tuesday stated that all medical devices shall be governed under the provisions of the Drugs (Prices Control) Order, 2013, with effect from Wednesday, it added.
"Therefore, the maximum retail prices (MRPs) of all the medical devices would be monitored by the government under the provisions of Para 20(1) of the DPCO, 2013, to ensure that no manufacturer/importer increases the MRP of a drug more than 10 per cent of MRP during preceding 12 month and where the increase is beyond 10 per cent of maximum retail price, it shall reduce the same to the level of ten percent of maximum retail price for next twelve months," the statement said.
Government is regulating 24 class of medical devices which have been notified/regulated as drugs under Drugs & Cosmetics Act, 1940 and Drugs & Cosmetics Rules, 1945. Of the above, 4 medical devices viz. (i) Cardiac Stents (ii) Drug Eluting Stents (iii) Condoms and (iv) Intra Uterine Device (Cu-T) are scheduled medical devices for which ceiling prices have been fixed. These 4 medical devices are under price control. As regard remaining non-scheduled medical devices which are notified/regulated as drugs, NPPA is currently monitoring Maximum Retail Prices (MRPs) under Para 20 of the DPCO, 2013 to ensure that no manufacturer/importers can increase the price more than ten percent in preceding twelve months.
The manufacturer and importer shall also be liable to deposit the overcharged amount along with interest thereon from the date of increase in price in addition to penalty, it added.
In another statement, the government also said that in compliance of the provisions of Drugs (Price Control) Order, 2013, the NPPA has increased the ceiling price of 883 scheduled formulations.
The increase in ceiling price is based on the Wholesale Price Index.The revision in ceiling price of formulations includes the revision of ceiling price of cardiac stents also. The revised prices will be applicable from Wednesday.