Medical Device Industry Opposes Indian Draft Bill Over Pharma Treatment

India's medical device industry, alongside healthcare groups, is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. The draft legislation, which aims to overhaul the 86-year-old regulatory framework for pharmaceuticals, is being criticized for treating medical devices in the same manner as pharmaceutical products. Industry representatives argue that such an approach could stifle innovation, investment, and manufacturing within the sector.

Concerns Over Regulatory Approach

The draft bill's approach to regulating medical devices has been met with significant resistance from various industry associations. These groups have articulated their concerns in a letter to the Union health minister, emphasizing the distinct differences between medical devices and pharmaceutical products. They argue that medical devices are engineering products with specific scientific and regulatory requirements that differ from those of drugs.

Key points of contention include the draft's use of pharmaceutical-centric terminology such as "adulterated", "spurious", and "misbranded", which are not typically applicable to engineering products. Additionally, the proposed bill introduces criminal penalties for regulatory lapses, including labelling errors and documentation issues, which industry leaders say could deter innovation and investment.

Global Comparison and Industry Pushback

Industry leaders have pointed out that the regulatory framework proposed in the draft bill does not align with international standards. In major markets like the EU, the US, Japan, the UK, and Australia, medical devices are regulated through risk-based assessments, quality management systems, and post-market surveillance. These regions rely on administrative enforcement rather than criminal penalties for compliance issues, a model the Indian industry believes should be emulated.

The draft bill proposes imprisonment of 1-7 years for various regulatory missteps, even in cases where no harm is caused. This punitive approach, critics argue, is inconsistent with global practices and could hinder India's aspirations of becoming a global leader in medical device manufacturing.

Calls for Rethinking the Draft Bill

In their August 8 letter, industry associations have urged the government to reconsider the draft bill, highlighting the need for a regulatory framework that supports growth and innovation in the medical devices sector. They stress the importance of recognizing the engineering and scientific distinctions between medical devices and pharmaceuticals, advocating for a more tailored regulatory approach.

As the draft bill undergoes inter-ministerial consultation, stakeholders in the medical device industry remain hopeful for amendments that will better align with international standards and foster a supportive environment for the sector's growth.