The medical device industry asked the Ministry of Health to reconsider the new regulatory law

The center’s industry body for medical device manufacturers 2022 is opposing plans to bring the new Medicines, Medical Devices and Cosmetics Bill to Parliament in the coming winter session and has expressed his displeasure in a letter to Health Minister Mansuk Mandaviya.

The Medical Devices Industry Association of India has announced that the move to introduce and approve the legislation aimed at regulating drugs and medical devices was done without even a single meeting with the major stakeholders.

“This action was taken surprisingly by a committee formed from the Central Drug Control Organization (CDSCO) inspectors without even the chairman from the Directorate General of Health Services (DGHS) etc. as usual,” the association’s letter said.

“This process was highly flawed with a conflict of interest in empowering regulators without consultation with stakeholders, without seeking input from MDTGAG (Medical Device Technical Advisory Group) and mandated to do so,” he added.

“Completely Different Products”

The association said it is surprising that the Parliamentary Committee’s 138th Report, issued on September 12, 2022, which suggests a separate law for medical devices as frequently sought by Indian manufacturers, has not been taken into consideration. In the year Since 1982, the central government has been wrongly trying to regulate medical devices as drugs, he said.

“These two are completely different medical products. Most of the developing countries have brought reforms and have separate laws for medical devices. Countries including Canada, Japan, Brazil have introduced the change. Earlier, even NIT Aayog had prepared a separate bill for medical devices – ‘Medical Device (Safety, Efficacy) and Innovation) Bill 2019 ‘with a view to having separate legislation and separate regulation’, the association said.

Currently, the draft law has been requested to be returned to the Ministry of Health, after the appropriate consultation, democratic and pre-legislative process, it has been advised to re-submit special laws to control drugs and medical devices.