Medical Devices Industry Reiterates Need for Separate Regulatory Framework

The industry has been advocating for a distinct legal framework, arguing that medical devices require unique regulations separate from those governing drugs and cosmetics.

The medical devices industry in India is pushing back against the Union Ministry of Health and Family Welfare's (MoHFW) proposed inclusion of provisions for medical devices in the draft New Drugs, Medical Devices, and Cosmetics Bill, 2023.

The draft New Bill, which seeks to replace the 83-year-old Drugs and Cosmetics Act, aims to regulate the import, manufacture, distribution, and sale of drugs, medical devices, and cosmetics while ensuring their quality, safety, efficacy, and performance.

The industry has been vocal in its demand for a separate regulatory framework and department specifically tailored for medical devices. Despite their calls, the Ministry insists that stakeholder comments have been considered and incorporated into the Bill.

In response to a query from Member of Parliament A D Singh in the Rajya Sabha, Dr Bharati Pravin Pawar, Minister of State in the MoHFW, 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."

However, the medical devices industry has expressed dissatisfaction with the Ministry's response, citing concerns that their recommendations and consultations have not been adequately addressed.

Distinct Legal Framework for Better Regulation

The industry has been advocating for a distinct legal framework, arguing that medical devices require unique regulations separate from those governing drugs and cosmetics.

Under the current Drugs and Cosmetics Act of 1940, medical devices fall under the definition of drugs, as stated in Section 3(b). This broad classification has been a point of argument, with industry leaders emphasising the need for a more nuanced and specific regulatory approach to ensure patient safety and foster innovation.

The Association of Indian Medical Device Industry (AIMED) has been at the forefront of this advocacy, asserting that despite engagements with the Ministry, critical issues such as regulatory complexities, potential impacts on innovation, and the need for a favourable business environment remain unaddressed in the draft Bill.

Rajiv Nath, coordinator of AIMED Forum, expressed disappointment, noting that assurances from Union Minister Dr Mansukh Mandaviya yet to materialise into concrete actions. Despite calls for a committee to review the Bill through a clause-by-clause discussion, no such committee has been formed.

"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.

AIMED asserts that the lack of alignment with industry expectations could hinder the growth of the medical device sector and perpetuate dependence on imports.

"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).

Emphasising the national interest, he further highlighted that if the Bill is passed unchanged, it could pose challenges for the healthcare sector, which relies heavily on medical devices. This may lead to supply chain issues, risking a nationwide lockdown similar to the onset of COVID-19. Domestic manufacturers might struggle to meet demand during a pandemic.

As the debate between the government and the medical devices industry continues, the fate of the proposed legislation hangs in the balance, with implications for the future of healthcare in India. The industry remains hopeful for a collaborative and comprehensive regulatory framework that ensures patient safety, encourages innovation, and supports the growth of the medical devices sector.