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3 Apr 2020

Medical Devices Regulation Update – India : All medical devices will be treated as drugs from 1st of April, 2020. Learn the implication.

The central government on Tuesday notified all medical devices sold in the country will be treated as drugs under the Drugs and Cosmetics Act with effect from April 1, 2020. This means, all medical devices will be regulated by the government as drugs for quality control and price monitoring.

Current Medical Devices Regulation in India:

  • Currently, 24 medical devices are regulated under the Drugs and Cosmetics Act.

Present Medical Devices Regulation applicable from 1st of April, 2020 in India:

  • All medical devices sold in the country will be treated as drugs under the Drugs and Cosmetics Act with effect from April 1, 2020.
  • Following this order, all medical devices used to treat a patient – be it syringes, needles, cardiac stents, knee implant, digital thermometers, CT scan, MRIs, dialysis machines – will be regulated under the DCA.
  • As per the notification, four medical devices, cardiac stents, drug eluting stents, condoms and intra uterine devices (Cu-T), are scheduled medical devices for which ceiling prices have been fixed. These four 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 per cent in preceding twelve months.

What if marketers are overcharging?

With the Essential Commodities Act, 1955, the manufacturer/importer will also be liable to deposit the overcharged amount along with interest thereon from the date of increase in price in addition to penalty.

https://twitter.com/nppa_india/status/1245011127576100865?s=20

KPE – C- 018 Medical Devices Regulation

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