Govt to regulate medical devices as drugs: NPPA
National Pharmaceutical Pricing Authority under the Ministry of Chemicals and Fertilizers notified on Tuesday that from April 1, 2020, all medical devices shall be regulated by the government as drugs. Medical devices shall be governed under the provisions of the Drugs (Prices Control) Order, 2013, according to the notification. This has been done for the twin purposes of quality control and price monitoring.
“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 notification stated. Further, 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, according to the statement.