States` response on medical equipment bill awaited
New Delhi: A bill for regulating medical equipment has been sent to the state governments for consultations and the centre is awaiting their response, Minister of State for Health and Family Welfare Dinesh Trivedi said on Friday.
He said his ministry was keen on quick finalisation of the bill.
"Health is a state subject. Unless the state governments give feedback, we can do absolutely nothing," Trivedi said at a workshop of medical device regulators here.
The minister added that the central government was contemplating on setting a deadline for responses from state governments for the draft bill which has been sent to them.
"We have given all inputs to the state governments. However, now we are thinking of giving them a deadline for submitting their response," he said.
The Central Devices Act, proposed by the health ministry last year, aims at creation of a Medical Device Regulatory Authority for regulating medical devices manufactured and used in the country.
The present regulatory control over medical devices is under the provisions of the Drugs and Cosmetics Act.
"Only 14 notified medical devices are being regulated under the act," Trivedi said.
He added that state governments are apprehensive about the bill impinging upon their rights.
"The states want to keep the right for giving licences for the equipment," he said, adding: "We need uniform standards. Each state cannot have its own regulation."
The new act will classify medical equipment in four classes. Class A will include equipment like thermometers and X-ray films, and will be self-regulatory.
Sophisticated devices in categories B and C will have to be approved by the state agencies while category D life-saving equipment will get approval from the central government on the recommendation of the state government.
"Clinical trials, export of equipment and licensing them are some of the core issues," Drugs Controller General of India Surinder Singh said.
He, however, did not give a deadline for the bill.
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