Medical Device Industry Challenges India's Draft Drugs Bill

India's medical device industry is raising concerns over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which they argue inaccurately categorizes medical devices as pharmaceutical products. Industry representatives fear this approach could stifle innovation and deter investment by imposing stringent regulatory measures traditionally reserved for drugs.

Concerns Over Regulatory Approach

The draft bill, currently under inter-ministerial review, has drawn criticism from various associations representing manufacturers, healthcare providers, and patient advocacy groups. In a letter dated August 8 to the Union Health Minister, these groups warned that the bill does not establish a conducive regulatory environment for the growth and global competitiveness of India's medical device sector.

One of the primary issues highlighted is the use of pharmaceutical-centric language within the bill. Terms such as "adulterated," "spurious," and "misbranded" are borrowed from drug regulations, applying criminal penalties for what the industry describes as engineering deviations. These could include labeling errors or documentation lapses, which, under the draft bill, may result in imprisonment of one to seven years, even in cases where no harm has occurred.

Global Regulatory Practices

Industry leaders point out that this punitive approach contrasts with international practices. In regions like the European Union, United States, Japan, United Kingdom, and Australia, medical devices are governed by risk-based conformity assessments, quality management systems, and post-market surveillance. Regulatory frameworks in these regions typically favor administrative enforcement over criminal penalties.

The bill's critics argue that treating medical devices as pharmaceuticals fails to recognize the fundamental differences between the two categories. Medical devices are primarily engineering products, requiring regulatory oversight distinct from that of pharmaceuticals.

Potential Impact on India's Medical Device Ambitions

The opposition to the draft bill underscores concerns about its potential impact on India's aspirations to become a global hub for medical device manufacturing. Stakeholders warn that the proposed regulations could discourage domestic and foreign investment, ultimately hindering the sector's growth and innovation.

As the draft bill undergoes further consultation, industry groups are advocating for a regulatory framework that aligns more closely with global standards and reflects the unique nature of medical devices. They emphasize the need for policies that support innovation, investment, and the safe production of medical devices without resorting to punitive measures more suited to pharmaceutical regulation.