medical device industry asks health ministry to reconsider new regulatory bill 1

The 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…

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