From April 1, 2020, all medical devices used to treat a patient — be it syringes, needles, cardiac stents, knee implant, digital thermometers, CT scan, MRIs, dialysis machines – have been brought under the ambit of the Drugs and Cosmetics Act (DCA). In simple words, these will be regulated by the Government as drugs for quality control and price monitoring.
Till now, the Government had been regulating only 24 classes of medical devices.
The National Pharmaceutical Pricing Authority (NPPA), a government regulatory agency, issued a notification recently in this regard.
The NPPA’s move follows the Union Health Ministry’s notification that brought the medical equipment used on humans as drugs under Section 3 of the Drugs and Cosmetics Act with effect from April 1, 2020. The Ministry, through a gazette notification, also released the Medical Devices Amendment Rules, 2020, for mandatory registration of medical devices.
Aimed at ensuring that all medical devices meet certain standards of quality and efficacy, the notification will also make medical device companies accountable for quality and safety of their products, noted a senior health official, said a senior NPPA official.
Also, the manufacturers cannot raise price as per their whims and fancies. “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” she said.
The 24 classes of medical devices have been notified/regulated as drugs under Drugs & Cosmetics Act 1940 and Drugs & Cosmetics Rules 1945."
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.
The 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 per cent of MRP during 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 official added.