NITI Aayog to ask views of the affected patients on the regulation of medical devices
In a first, NITI Aayog has asked the affected patients of J&J’s hip implants to help build consensus on the proposed regulation of medical devices.
At present, India doesn’t have a law to compensate patients facing the adverse effects of faulty implants or medical devices. After the J&J hip implant case, which changed the lives of many patients and made the issue of compensation more relevant, NITI Aayog has proposed separate legislation to govern medical devices. The new draft legislation proposes to allow the patients suffering from faulty medical devices and implants to demand compensation from the manufacturer or company importing them. It also calls for a separate regulator empowered to govern medical devices, independent from drugs.
The health ministry opposed the idea of a separate regulator for medical devices. But NITI Aayog has gone ahead and started consultations with stakeholders. Civil society groups, medical device lobby groups, former drug controllers, current state drug controllers and patients from the J&J case will attend the first consultation.
Rajiv Nath, forum coordinator at the Association of Indian Medical Device Industry (AiMeD) said: “Devices are engineering items and not medicines – an X-ray machine by no stretch of the imagination can be called a drug.” He also added that continuous attempts to regulate devices under the Drugs Act without an assurance of migrating to separate legislation will do more harm than good to the ‘Make in India’ campaign.
The draft, titled Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019, has not been put up in the public domain. “There is a need felt for establishing a more enabling regulatory system to nurture and boost the medical devices sector. The National Health Policy 2017 envisages strengthening the regulation of medical devices and establishing a regulatory body for medical devices to unleash innovation and the entrepreneurial spirit for medical devices in India,” Niti Aayog said in its invitation to the first consultation. Currently, there is no distinction between the regulatory treatment of drugs and medical devices. Both are regulated by the Central Drugs Standard Control Organisation under the health ministry. The ministry issued a notification in October to state that it will regulate all medical devices from December 1.
The NITI Aayog has met senior officials of the health ministry, the Department of Pharmaceuticals and the Department for Promotion of Industry and Internal Trade on the proposed legislation. ‘The draft will be put up in the public domain once NITI Aayog builds a consensus’, reads a report published in the Economic Times.
Source: The Economic Times