All imported, as well as locally manufactured medical devices sold in India will soon be required to clear specific safety and quality standards. The move is aimed at preventing fiascos such as the one involving Johnson and Johnson hip implants.
A 2 April meeting of Drugs Technical Advisory Board (DTAB), India’s highest advisory body on drugs, decided to notify medical devices as drugs under the Drugs and Cosmetics Act (DCA), government officials aware of the development said.
Once notified, import, manufacture and sale of all medical devices will need to be certified by the Central Drugs Standard Control Organisation (CDSCO). Manufacturers will also have to seek licences from the Drug Controller General of India (DCGI).
Mint has seen a copy of the minutes of the DTAB meeting.
“The regulation will help ensure safe and tested medical devices reach the end user," the official cited above said on condition of anonymity. Currently, only 23 medical devices are regulated under the Act. The change will be implemented in a phased manner.
“Representations have been received from various stakeholders for regulating all non-notified medical devices since concerns have been raised from time to time regarding safety, quality and performance of various medical devices, including diagnostic kits manufactured or imported in the country. Many of the medical devices like equipments analysers, instruments etc used in various healthcare facilities for diagnosis treatment, mitigation are currently out of scope of regulation under the Drugs and Cosmetics Act," the DTAB noted.
A health ministry committee formed on 4 February had recommended that all manufacturers should register details on a special portal to be developed for this purpose. On 8 February, the government put implantable medical devices, CT scan equipment, MRI equipment, defibrillators, dialysis machines, PET equipment, X-Ray machines and bone marrow cell separators under the purview of the DCA. Surgical gowns, surgical drapes and incision drapes will also be notified under the Act.
Medical devices are already classified on the basis of the risks they pose. Low-risk devices are classified as ‘Class A’; devices with low to moderate risk are classified as ‘Class B’; devices with moderate risk are classified as ‘Class C’; and devices having high risk are in ‘Class D’ category.
Rajiv Nath, forum co-ordinator, Association of Indian Medical Device Industry (AiMeD), said the move lacks strategic direction. “It’s imperative to have a separate law as devices are engineering items and not medicines - an X Ray machine by no stretch of imagination can be called a drug; so the continued attempt to regulate devices as drugs is incomplete and incorrect. No representative of medical devices industry or a regulatory expert is invited to these important meetings that decide the fate of the industry". Calling it a positive step with regard to patient safety, Sunil Attavar, president of Karnataka Drugs and Pharmaceuticals Manufacturers’ Association, said: “This is a very positive step keeping in mind patient safety and aligns to global regulations. It will mean that all products that meet the definition, irrespective of whether they have been notified or not, will be covered and hence, will have to meet certain standards of quality and efficacy."