MEDICAL DEVICES NOTIFIED AS DRUGS

With effect from 1st April, 2020, all Medical Devices shall be regulated by the Government as Drugs for quality control and price monitoring.


About:

  1. Therefore, the Maximum Retail Prices (MPRs) of all the Medical Devices would be monitored by the Government under the provisions of Para 20(1) of the Drugs (Prices Control) Order, 2013.

  2. This will ensure that no manufacturer/importer increases the MRP of a drug more than 10% of MRP during preceding 12 month.

  3. Further, the manufacturer/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.

  4. Earlier, the National Pharmaceutical Pricing Authority (NPPA) vide Notification dated 11th February, 2020, stated that all medical devices shall be governed under the provisions of the Drugs (Prices Control) Order, 2013 (DPCO, 2013) w.e.f. 1st April 2020.

Source : PIB

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