Medical Device Sector Rejects New Drugs Bill Over Criminalization Fears

The Association of Indian Medical Device Industry (AiMeD) has officially registered its opposition to a new Bill seeking to overhaul the Drugs and Cosmetics Act, 1940. In a letter addressed to Union Health Minister J P Nadda, the association claimed that the draft was prepared without adequate stakeholder consultation. Industry leaders argue that the current Bill is merely a revived version of drafts from 2022 and 2023, which were previously halted due to similar concerns. The sector maintains that the proposed legislation fails to provide a modern regulatory foundation, potentially stifling innovation and global competitiveness for Indian manufacturers.

A primary point of contention is the Bill's treatment of medical devices as an adjunct to pharmaceuticals. AiMeD has specifically opposed the use of pharmaceutical terms like "spurious" or "misbranded" for complex medical engineering products. Furthermore, the industry is alarmed by the criminalization of administrative and technical lapses, such as labeling errors or software version mismatches, which could result in up to two years of imprisonment. This stands in direct contrast to the government's Jan Vishwas Bill, which aimed to decriminalize minor business lapses to improve the ease of doing business in India.

The draft Bill also proposes significantly expanded "police-style" powers for drug inspectors, including the authority to arrest individuals and order the immediate cessation of business activities based on "reason to believe" an offense is occurring. The medical device industry has called for a separate regulatory body comprised of engineers and biomedical specialists, rather than pharmaceutical regulators. What happens next depends on the Health Ministry's willingness to hold structured consultations. Failure to address these concerns could lead to increased corruption and a shift in investment away from India's burgeoning medical technology sector.