AiMeD and Operon Strategist Call for Recall of New Medical Devices Bill 2023 to Safeguard Make in India Campaign

AiMeD (Association of Indian Medical Device Industry) and Operon Strategist, two prominent organizations in the Indian medical device industry, have jointly called for the recall of the New Medical Devices Bill 2023. The move aims to safeguard the Make in India campaign, which promotes domestic manufacturing and self-reliance in the healthcare sector.

The New Medical Devices Bill 2023 was introduced by the Indian government with the intention of regulating the medical device industry and ensuring patient safety. However, AiMeD and Operon Strategist argue that certain provisions within the bill could have adverse effects on the Make in India campaign.

One of the major concerns raised by the organizations is the proposed requirement for mandatory local testing of medical devices. According to the bill, all medical devices manufactured in India or imported into the country would need to undergo testing at Indian laboratories approved by the Central Drugs Standard Control Organization (CDSCO). AiMeD and Operon Strategist argue that this provision could lead to delays in product launches and increased costs for manufacturers, ultimately hampering the growth of the domestic medical device industry.

Furthermore, the organizations highlight that India currently lacks sufficient testing infrastructure and capacity to handle the increased demand resulting from mandatory local testing. This could lead to a backlog of products awaiting approval, further impeding the growth of the industry. AiMeD and Operon Strategist suggest that instead of mandatory local testing, a risk-based approach should be adopted, where only high-risk devices undergo local testing while low-risk devices can rely on international certifications.

Another concern raised by AiMeD and Operon Strategist is the proposed provision for price control on medical devices. The bill suggests that the government may fix the ceiling price for certain medical devices to ensure affordability and accessibility. While the intention behind this provision is noble, the organizations argue that it could discourage investment in research and development, as manufacturers may struggle to recover their costs if prices are artificially capped. They propose that instead of price control, the government should focus on promoting competition and transparency in the market to drive down prices naturally.

Additionally, AiMeD and Operon Strategist express concerns about the lack of consultation with industry stakeholders during the drafting of the bill. They argue that the input of industry experts is crucial to ensure that regulations are practical, feasible, and aligned with the goals of the Make in India campaign. The organizations call for a collaborative approach, where industry representatives are actively involved in shaping policies and regulations.

In conclusion, AiMeD and Operon Strategist’s call for the recall of the New Medical Devices Bill 2023 is driven by their commitment to safeguarding the Make in India campaign. They believe that certain provisions within the bill, such as mandatory local testing and price control, could hinder the growth of the domestic medical device industry. By advocating for a risk-based approach to testing and promoting competition rather than price control, the organizations aim to strike a balance between patient safety and industry growth. They emphasize the importance of industry consultation to ensure that regulations are practical and aligned with the goals of the Make in India campaign.

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