Medical Device Industry Opposes Draft Bill on Regulatory Grounds

India's medical device sector has voiced strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that the draft legislation inappropriately classifies medical devices alongside pharmaceuticals. Industry representatives warn that this could stifle innovation and discourage investment in the country's burgeoning medical device market.

Concerns Over Regulatory Approach

The draft bill, currently under inter-ministerial consultation, has drawn criticism for its approach to regulating medical devices. Industry associations, including manufacturers, traders, and healthcare providers, have collectively urged the Union Health Ministry to reconsider the bill's provisions. They argue that the draft fails to recognize the fundamental differences between medical devices and pharmaceutical products.

In a letter dated August 8, these groups highlighted that medical devices are primarily engineering products, requiring a distinct regulatory framework separate from that of drugs. The letter, seen by ET, stresses that the bill's continued use of drug-centric language—such as terms like "adulterated," "spurious," and "misbranded"—is inappropriate for the medical device sector.

Impact on Innovation and Investment

Critics of the draft bill fear that its stringent penal provisions could deter manufacturing and innovation. The proposed legislation includes criminal penalties, ranging from one to seven years of imprisonment, for various regulatory lapses, including labeling errors and documentation mistakes, even when no harm is caused. This approach contrasts sharply with international regulatory practices, where administrative enforcement is preferred.

Globally, regions like the European Union, United States, Japan, UK, and Australia regulate medical devices through risk-based assessments, quality management systems, and post-market surveillance rather than imposing harsh criminal penalties. The industry argues that adopting a similar approach in India could foster a more conducive environment for growth and global competitiveness.

Call for a Separate Regulatory Framework

The draft bill's critics argue for a dedicated regulatory framework that recognizes the unique characteristics of medical devices. Such a framework would facilitate the sector's growth by allowing innovation to flourish without the overhang of punitive measures more suited to the pharmaceutical industry.

The pushback from the industry comes as the government seeks to modernize its regulatory landscape, replacing an 86-year-old law governing pharmaceuticals. However, stakeholders within the medical device sector are urging policymakers to ensure that the new regulations do not inadvertently stymie progress in a field where India hopes to establish itself as a global leader.