11,797.90-31.5
Stock Analysis, IPO, Mutual Funds, Bonds & More

NITI Aayog to seek views of affected patients on medical devices law

In a first, the government's think-tank has asked trouble stricken patients of J&J's hip implants to help build consensus on the proposed regulation of medical devices.

, ET Bureau|
Last Updated: Dec 18, 2019, 08.03 AM IST
0Comments
TNN
NITI-Aayog-TNN

Niti Aayog had proposed a separate legislation to govern medical devices, after the J&J hip implant case.

Tax Calculator
New Delhi: Vijay Vojhala, 46, who was adversely affected by Johnson & Johnson’s faulty hip implant, is among those invited by Niti Aayog to take part in consultations on a proposed law on medical devices scheduled on Wednesday. In a first, the government’s think-tank has asked trouble stricken patients of J&J’s hip implants to help build consensus on the proposed regulation of medical devices. India currently doesn’t have a law to compensate patients facing health problems due to faulty implants or medical devices. Niti Aayog had proposed a separate legislation to govern medical devices, after the J&J hip implant case, which changed the lives of many patients and made the issue of compensation more relevant.

New Delhi-based Rajeev Thukaral, whose wife Mamata lives with two faulty implants, will also be present at the meeting. The draft legislation proposes to allow patients suffering from faulty medical devices and implants to demand compensation from the manufacturer or company importing them. It calls for a separate regulator empowered to govern medical devices, independent from drugs.

1

While the health ministry, which is the custodian of the central drug regulator, is averse to the idea of a separate regulator for medical devices, Niti Aayog has gone ahead and started consultations with stakeholders. The first consultation on Wednesday will be attended by civil society groups, medical device lobby groups, former drug controllers, current state drug controllers and patients from the J&J case. “We are looking forward to be briefed on the draft by Niti Aayog.

Devices are engineering items and not medicines – an X-ray machine by no stretch of the imagination can be called a drug,” said Rajiv Nath, forum coordinator at the Association of Indian Medical Device Industry (AiMeD). “Continued attempts to regulate devices under the Drugs Act without an assurance of migrating to a separate legislation will do more harm than good to the ‘Make in India’ campaign.” PUBLISHING AFTER CONSENSUS The draft, titled Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019, has not been put up in the public domain. “We have been told that Niti Aayog will give a presentation on the draft legislation while asking for our suggestions later on the proposed draft,” said one person who is to attend the meeting. “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. 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. According to the draft legislation accessed by ET, the government will establish the Medical Devices Administration under the Directorate General of Health Services.

India currently imports 80-90% of its medical devices. The think tank 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 41-page draft will be put out in the public domain once Niti Aayog builds a consensus, people familiar with the matter said.

The health insurance scheme for the poor has triggered unprecedented demand for medical devices, Niti Aayog said. “It is the government’s endeavour to make India a medical products’ manufacturing and innovation hub for the world,” the invitation added.

Also Read

Niti Aayog seeks Cabinet nod for battery push

Niti Aayog to develop National Data Platform

NITI Aayog member justifies internet ban in J&K

Niti Aayog's report to reveal India's health system

NITI Aayog extends deadline for consultations on draft model concession agreement

Comments
Add Your Comments
Commenting feature is disabled in your country/region.

Other useful Links


Copyright © 2020 Bennett, Coleman & Co. Ltd. All rights reserved. For reprint rights: Times Syndication Service