Context

The central government 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.

About

• ‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
  • diagnosis, prevention, monitoring, treatment or alleviation of disease
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury
  • investigation, replacement, modification, or support of the anatomy or of a physiological process
  • supporting or sustaining life
  • control of conception
  • disinfection of medical devices
  • providing information by means of in vitro examination of specimens derived from the human body
• The government is regulating 24 classes of medical devices which have been notified/regulated as drugs under Drugs & Cosmetics Act 1940 and Drugs & Cosmetics Rules 1945.
• Currently, 24 medical devices are regulated under the Drugs and Cosmetics Act.
• 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.

What is the need for regulation?

• The National Pharmaceutical Pricing Authority (NPPA), a government regulatory agency, is monitoring Maximum Retail Prices (MRPs) of remaining non-scheduled medical devices, which have been regulated as drugs.
• The objective is to ensure that no manufacturer or importer increases the price of a drug more than ten per cent of MRP during preceding twelve months.
• 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.
• Further, 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.

The government will now have oversight on the medical devices industry and its activities in the country.