With prime focus of authorities in preventing fiascos such as the one involving Johnson and Johnson hip implants, all imported, as well as locally manufactured medical devices in India will soon have to clear specific safety and quality standards.
Following the 2nd April meeting, Drugs Technical Advisory Board (DTAB), India’s highest advisory body on drugs decided to notify that medical devices as drugs under the Drugs and Cosmetics Act (DCA). Once notified, import, manufacture and sale of all medical devices will need to be certified by the Central Drugs Standard Control Organization (CDSCO). Manufacturers will have to procure licenses from Drug Controller General of India (DCGI), in order continue the manufacture and sale of medical devices.
“The regulation will help ensure safe and tested medical devices reach the end user," government officials aware of the development 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.
Recommendations by a health ministry committee formed on 4th February guides manufacturers to 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.
Based on the potential risks posed by medical devices, they are classified as Low-risk devices in ‘Class A’; devices with low to moderate risk in ‘Class B’; devices with moderate risk in ‘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". Viewing it as positive step towards enhancing patients 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."
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