Medical devices are not pharma products, companies say while opposing Draft Bill

A proposed overhaul of India's Drugs and Cosmetics Act, 1940, is encountering resistance from the emergent medical device sector. Representatives from pharmaceutical and medical device associations claim that the proposed legislation fails to incorporate valuable input from industry stakeholders during its development. They argue that the current bill mirrors a version previously introduced in 2022 and 2023, with only minor modifications.

The Association of Indian Medical Device Industry has raised concerns, contending that the bill does not establish a robust regulatory framework to support the growth, innovation, and competitiveness of India's medical devices industry on the global stage. The legislation continues to treat medical devices as mere pharmaceutical adjuncts, disregarding their distinct scientific, engineering, and regulatory characteristics.

The industry association has also criticized the inclusion of pharmaceutical-related terms, such as "spurious" or "misbranded," for devices and the criminalization of minor issues like labeling errors or documentation lapses. They contend that the draft fails to incorporate device-specific considerations, such as biocompatibility, usability engineering, and software lifecycle safety, which would place India behind global regulators in this sector.

Furthermore, the industry body has expressed dissatisfaction with the expanded "police-style powers" granted to inspectors in the new bill, which include the authority to halt specified activities and arrest individuals suspected of committing drug-related offenses. In contrast to the proposed legislation, the Indian government's Jan Vishwas Bill has taken steps to decriminalize minor lapses, aiming to foster a more business-friendly environment for industries.