Medical devices to be regulated as drugs for quality control, price monitoring: Government

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 […]

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.

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.

Source Article

Lois C. Ferrara

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