AiMed Demands Calling Back of the New Medical Devices Bill, 2023

Rajiv Nath highlighted that the Bill ignores ground realities, patient concerns, safety, and local players' investments. He asserted the bill leans heavily towards MNCs, spelling trouble for domestic players.

Raising concerns over the newly passed Drugs, Medical Devices, and Cosmetics Bill 2023, Rajiv Nath, forum coordinator of AiMeD said the said Bill should be called back.

'œThe bill must be recalled for further deliberations and corrections failing which Prime Minister Narendra Modi's ambitious '˜Make in India' campaign will be derailed', said Rajiv Nath, forum coordinator, Association of Indian Medical Industry (AiMeD).

As per Nath, the Bill is far away from the ground realities, patient worries and interests and their safety. Further he said that the Bill did not pay attention to the cause of local medical device manufacturers who have put in huge investment.

He argued that the Bill was created by a group of regulators who appear to have been misled by the MNC lobby to suit their own interests without adhering to proper democratic pre-legislative procedures. It will continue to attempt to control pharmaceuticals and devices under the disguise of distinct sections.

'œThe Bill is strongly in favor of MNCs. The New Bill will prove catastrophic for domestic players. Nothing could be more prudent than recalling the Bill by the Union Ministry of Health and Family Welfare and referring it to a new committee of Medical Devices regulatory experts under the Chairmanship of ICMR or DST or DBT as devices are engineering products and not drugs,' added Nath.

The concerns raised revolve around the Bill's potential impact on the 'Make in India' initiative, which seeks to bolster domestic manufacturing capabilities. Nath highlighted that the legislation, if adopted, might have adverse implications such as discouraging investments in local manufacturing, inadvertently legalising low-quality cheaper imports, and undermining patient safety.

He further questioned the need to consider impactful legislation from various countries in drafting the Bill.

Nath's argument focuses on the need for a separate regulatory framework for medical devices, distinct from drugs. He advocated for a simplified, implementable, and reasonable law encouraging investment, entrepreneurship, and adherence to manufacturers' and regulators' regulatory conformity requirements.

He pointed out that medical devices are engineering products akin to cars. They require distinct regulatory pathways and considerations for storage, transportation, installation, maintenance, and calibration to ensure patient safety throughout their lifecycle.

Previously, responding to various concerns, the Parliamentary Standing Committee on Health and Family Welfare recommended formulating a separate department and legislation for the medical device industry. The committee's advice aligns with the sentiment that the Medical Devices sector requires dedicated attention and distinct regulatory provisions.

Succinctly, the New Drugs, Medical Devices, and Cosmetics Bill 2023 has generated apprehensions within the domestic medical device industry, with concerns about its impact on the 'Make in India' campaign and local manufacturers' interests.

While proponents acknowledge the need for regulatory enhancement, they emphasise the significance of formulating a separate and comprehensive legislative framework for medical devices. The debate underscores the complex balance between encouraging domestic manufacturing, ensuring patient safety, and adhering to global best practices in the realm of medical devices.