The Association of Indian Medical Device Industry (AiMeD), representing over 1200 manufacturers, has reiterated its call for a distinct regulatory framework for the medical device sector. This demand follows the recent rejection of petitions challenging the classification of medical devices as drugs by the Delhi High Court.
AiMeD’s Call for Separate Regulations
The Association of Indian Medical Device Industry (AiMeD) has once again emphasized the need for a distinct regulatory mechanism tailored to the medical device industry. This call stems from a deep understanding of the unique requirements and challenges faced by the sector.
Legal Disputes and the Need for Resolution
The recent decision by the Delhi High Court to reject petitions challenging the classification of medical devices as drugs under the Drugs and Cosmetics Act has brought this issue to the forefront. It underscores the significance of addressing industry grievances promptly and effectively.
Parliamentary Support for Separate Legislation
Support for separate legislation for medical devices is not limited to industry stakeholders alone. The Parliamentary Standing Committee on Health and Family Welfare’s 146th report, dated August 4, 2023, emphasizes the importance of creating a world-class regulatory framework and reducing dependence on imports through separate legislation. This aligns with the direction set by the National Health Policy 2017.
NITI Aayog’s Draft Bill: A Way Forward
The draft Bill proposed by NITI Aayog in November 2019 offers a progressive approach to regulating medical devices independently from drugs. It encourages engagement with all stakeholders, including manufacturers, traders, and patients, to ensure a comprehensive and balanced regulatory framework.
Concerns Surrounding the New Drugs, Medical Devices, and Cosmetics Bill
The New Drugs, Medical Devices, and Cosmetics Bill, of 2023, has raised concerns within the domestic medical device industry. The industry is particularly focused on regulations related to exports, the establishment of a national regulatory authority, and compliance with international guidelines such as WHO recommendations.
Review of Pre-Owned Medical Devices Import
AiMeD expresses optimism about a review of the decision to permit the import of pre-owned medical devices. This review is essential, as it affects the competitiveness of domestically manufactured devices. Understanding the motives behind importing pre-owned equipment and the global context of such imports is crucial.
