SUMMARY
Niti Aayog had proposed the Draft Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019
Health ministry is the official custodian of the Drugs and Cosmetics Act and the drug regulatory authority in the country
Both the government bodies are having rifts over regulations of medical devices in India
The need for an independent regulator for medical devices in India has always been a matter of concern for the health ministry and Niti Aayog in the past. However, a rift seems to have emerged between both the government bodies following the faulty hip implant case involving US-based Johnson and Johnson.
Niti Aayog had proposed for legislation for medical devices and an independent regulator for this industry with the Draft Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019. The Aayog had said that the need to have a strengthened regulation was spelt out in the government’s National Health Policy 2017.
However, as the health ministry is the official custodian of the Drugs and Cosmetics Act and the drug regulatory authority in the country, an ET report highlighted that there is now a difference of opinion between both government bodies over the role of an independent regulator for medical devices and proposed legislation for these gears.
The proposed norms under the Aayog’s bill include compensation to the patients from the manufacturer or importer of the device in case of any suffering because of faulty medical devices and implants. However, the ministry has now raised concerns to the Niti Aayog to have wider consultations with stakeholders for the proposed legislation for medical devices.
The media report further quoted an unnamed official from the health ministry raising questions like whether the existing act is not sufficient to regulate medical devices. “Tomorrow there could be a demand to have a separate law for regulating cosmetics. Are we going to have a separate law for cosmetics then?,” he was quoted as saying.
Earlier this month, the rising rift between the bodies called for an official meeting. The officials from the Niti Aayog met senior officials of the health ministry, department of pharmaceuticals and the department of industrial policy and promotions (DIPP) on the proposed legislation.
At the meeting, another official from the health ministry said that consultations would enable the think tank to create a broader consensus on the proposed Act. The official further said that the ministry wants other stakeholders, including manufacturers, to be consulted and asked if there is a need for a separate act and a regulator or not.
Currently, the Central Drugs Standard Control Organisation under the health ministry is the nodal body for regulating both drugs and medical devices in the country. Moreover, in an October 2019 notification, the ministry has mandated that it is going to directly regulate all medical devices from December 1, 2019.
However, the Niti’s draft calls for an establishment of Medical Devices Administration under the Directorate General of Health Services (DGHS) to regulate medical devices in the country.
In response to the Niti’s draft, the second official from the ministry told ET that there is no country in the world with separate regulators and laws for medicines and medical devices. “If a road map has been prepared by the health ministry then what is the purpose of a new law?” he added.
