Medical device industry asks Health Ministry to reconsider new regulatory Bill

The new Bill, to regulate drugs and medical devices, was formulated without input from major stakeholders, device manufacturers claim. They also want a separate law for regulation of their industry.

An industry body for medical device manufacturers is opposing the Centre’s plan to bring the New Drugs, Medical Devices and Cosmetics Bill, 2022 to Parliament in the upcoming monsoon session, and has written to Health Minister Mansukh Mandaviya, expressing its dismay.

The move to introduce and pass the legislation, which aims to regulate drugs and medical devices, has been done without holding even a single meeting with major stakeholders, the Association of Indian Medical Device Industry said.

“This move has been made in a strange manner by a Committee formed by regulators from Central Drugs Standard Control Organisation (CDSCO) with even the chairman not being from Directorate General of Health Services (DGHS) etc as is usually the practice,” the Association’s letter said.

“This process was highly flawed with conflict of interest to empower regulators by a Bill drafted by regulators without even seeking inputs from MDTAG (Medical Device Technical Advisory Group) and discussion with stakeholders despite being directed to do so,’’ it added.

The Association said that it was also strange that the Parliamentary Committee’s 138th report, released on September 12, 2022, which recommends a separate law for medical devices as was being regularly sought by Indian manufacturers, had not been taken into consideration. It added that, since 1982, the Central Government has been attempting incorrectly to regulate medical devices as drugs.

“These two are entirely different medical products. Most progressive countries have brought in reforms and have separate laws for Medical Devices. Countries including Canada, Japan, Brazil have introduced the change. Earlier even NIT Aayog had drafted a separate bill for medical devices - ‘The Medical Device (Safety, Effectiveness and Innovation) Bill 2019’ with the intention to have a Separate Law and Separate Regulatory,’’ the Association said.

It has now demanded that the Bill be returned to the Health Ministry, with an advisory to resubmit separate laws to regulate drugs and medical devices after the due consultative, democratic and pre-legislative process.