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Health minister says comments from stakeholders considered and incorporated in the New Bill
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Our Bureau, New Delhi
December 20 , 2023
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Even as the medical devices industry in the country has been demanding a separate regulation and a department for the medical devices as against the proposed inclusion of provisions in the draft New Drugs, Medical Devices and Cosmetics Bill, 2023, the Union ministry of health and family welfare (MoHFW) has said that it has considered and incorporated the comments from the stakeholders in the Bill.
Responding to a question by the Member of Parliament A D Singh in the Rajya Sabha, Minister of State in the MoHFW Dr Bharati Pravin Pawar said, "Comments and inputs have been received from various stakeholders on the draft Drugs, Medical Devices and Cosmetics Bill, 2023 which had been published for public consultation. These have been considered and incorporated."
The Member of Parliament sought response from the Ministry on whether there is consistent demand by the industry to frame a separate law for medical devices and if so, the response of the Government.
Pawar responded that as per Section 3(b) of the Drugs and Cosmetics Act 1940, drugs include “such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central government”.
The medical devices industry in the country has been raising concerns that its inputs to the draft Bill has been overlooked by the Ministry even after the Department-related Parliamentary Committee backed their demand for a separate regulation and department for the segment, which is different from the drugs and cosmetics segments.
The Association of Indian Medical Device Industry (AIMED) has recently said that despite its consultations with the Ministry, the key issues such as regulatory complexities, the potential impact on innovation, and the need for a conducive business environment have yet to be adequately assured by redressal in the bill. The lack of alignment with industry expectations has raised fears of stifling growth and hindering technological advancements in the medical device sector and continued import dependence as easier to import high end medical devices than to get regulatory approval for domestic manufacturers, they said.
AIMED Forum Coordinator Rajiv Nath, while expressing his disappointment, said that even after the assurance given by Union minister of health and family welfare, and chemicals and fertilizers Dr Mansukh Mandaviya, no committee was formed to review the different tenets of the Bill on a clause-by-clause discussion to align it or as suggested to use earlier separate Bill drafted by NITI Aayog in 2019.
“The need of the hour is a progressive modern separate law for addressing patient safety concerns. NITI Aayog had drafted an excellent Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019 but in vain and we keep going in circles. Who gains from putting Indian manufacturers at a disadvantage over imports and by Drug pharmacists weighing biased regulatory controls? Even the impactful recent progressive legislations in countries like Canada, UK, EU, Brazil, Malaysia, Singapore and Saudi Arabia were not studied. Who blocked that progressive visionary Bill?” asked Nath.
He added that by keeping a chapter of penalties and punitive actions common with drugs, we are only reviving the Inspector Raj, which the nation cannot afford as we are working hard to make India self-reliant by promoting the ‘Make India’ spirit as envisioned by Prime Minister Narendra Modi.
"We need competent auditors from engineering and science background and not dominant pharmacists with expertise of Drugs applying their drug regulatory inspection-based knowledge on medical devices that cannot have guarantee of absolute safety and are seeking an overkill. Discussing the potential impact of the Bill, which appears to favor foreign players," said Dr. Giridhar Gyani, Director General of the Association of Healthcare Providers India (AHPI).
He emphasized, that in the national interest, it is crucial for us to highlight that if the Bill is passed as is, the healthcare providers sector, heavily reliant on medical devices and advocating for increased availability of affordable, high-quality, made-in-India medical devices, may once again face challenges in management of supply chain, leading to crisis and country wide lockdown similar to the onset of Covid. Domestic manufacturers might lose their capacity to swiftly address domestic demand, especially in the event of a pandemic.
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