JOIN USThe central government has begun the process of declaring eight types of medical devices, including all imaging equipment, as "drugs" under the Drugs and Cosmetics Act, 1940, in order to regulate their quality and prices in future.
The Central Drugs Standard Control Organisation issued a public notice last week seeking people's comments on the proposal to include all implantable medical devices and other high-end equipment under the purview of the eight-decade-old law that regulates the pharmaceutical business in India.
The devices proposed to be covered in the new rule include four imaging instruments — X-ray machines, CT scan, MRI and PET machines.
Others on the list are all implantable medical devices, defibrillators, dialysis machine and bone marrow cell separator.
Once these devices are legally termed as "drugs", the regulatory agencies would be in a position to ensure their quality for patient safety and control their prices, if required.
In May, the Drugs Technical Advisory Board recommended bringing seven of the eight devices under the ambit of the Drugs and Cosmetics Act. CDSCO later included bone marrow separator to the list.
Once final, the move can lead to price control on items like dental implants or heart pacemakers besides ensuring that hospitals and clinics maintain the quality of common X-ray machines and other notified instruments for patient safety.
"While we welcome the move to regulate implants and additional medical electronic equipment including imaging instruments to test waters for adequacy of Medical Device Rules of 2017, we also recommend third party, credible and independent audit to check the quality of these devices," Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry told DH.
After fixing the ceiling prices of coronary stents and knee implants, it is the first step by the government on the regulation of medical devices sold in India.
In the last two years, the National Pharmaceutical Pricing Authority collected pricing and sales data from 300 odd Indian medical device companies on 19 common devices that include disposable syringe and needles, heart valves and eye lens used in cataract surgery. However, NPPA is yet to take any follow up action.
"Clarity is also required on what kind of implantable devices would be covered in the proposed regulation. Will it include only long term (more than 30 days) implants or will the regulation be applicable to transient (less than one hour) and short term (between one hour and 30 days) implants," Nath said.