Context:

The central government notified all medical devices sold in the country are to be treated as drugs under the Drugs and Cosmetics Act with effect from April 1, 2020. This means all medical devices are now to 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 another 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
  • The 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 that have been notified/regulated as drugs under the Drugs & Cosmetics Act 1940 and Drugs & Cosmetics Rules 1945.
• Currently, 24 medical devices are regulated under the Drugs and Cosmetics Act(DCA).
• Following this order, all medical devices used to treat a patient – be it syringes, needles, cardiac stents, knee implants, digital thermometers, CT scans, MRIs, dialysis machines – will be regulated under the DCA.

The need for regulation

• The National Pharmaceutical Pricing Authority (NPPA)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 percent of MRP during the 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 the penalty.
• The government will now have oversight on the medical devices industry and its activities in the country.