‘Suggestions not accepted’: Bill to overhaul drugs law faces opposition from pharma, medical device sector

A proposed overhaul of India's Drugs and Cosmetics Act, 1940, is encountering strong opposition from the country's budding medical device sector. Key players in the pharmaceutical and medical device industries claim that no meaningful stakeholder consultation was held during the drafting process, suggesting the current bill bears little resemblance to previous versions from 2022 and 2023.

The Association of Indian Medical Device Industry has raised concerns about the bill's lack of regulatory foundation for India's medical devices sector to thrive globally, as it continues to treat devices as mere pharmaceutical adjuncts. The draft incorporates pharmaceutical-related terms, criminalizes minor issues, and omits essential device-specific concepts like biocompatibility and usability engineering, putting India behind global regulators.

Critics also point out that the bill criminalizes technical and administrative lapses, unlike the Jan Vishwas Bill, which decriminalized minor lapses to foster industry growth. Furthermore, the industry body argues that the bill grants inspectors excessive police-like powers, such as the ability to halt activities temporarily and arrest individuals suspected of committing drug-related offenses.

The Association of Indian Medical Device Industry has urged the formation of a new committee comprising engineers, clinicians, biomedical specialists, industry representatives, and patient safety groups to draft a separate medical devices act aligned with global best practices, such as the EU's Medical Device Regulation or the US FDA device framework, rather than relying on the current bill's provisions.