Industry Pushback: Medical Devices Not Pharmaceuticals, Say Companies

India's medical device industry is raising strong objections to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. The proposed legislation, which aims to overhaul the regulatory framework for pharmaceuticals and medical devices, has drawn criticism for treating medical devices akin to pharmaceutical products, potentially imposing stringent regulations that could harm the sector's growth and innovation.

Concerns Over Regulatory Approach

Industry groups and healthcare providers have expressed alarm over the bill's approach, which they argue does not appropriately distinguish between pharmaceuticals and medical devices. Medical devices, they point out, are engineering products that require a different regulatory framework than drugs. The bill's proposed criminal penalties for regulatory deviations, such as labelling errors or documentation lapses, are particularly contentious. Critics argue that these measures could deter investment and innovation within the sector.

In a letter dated August 8, industry associations urged the Union health minister to reconsider the bill's provisions. They warned that the current draft could hinder India's aspirations to become a global hub for medical device manufacturing and innovation. The letter highlighted that the draft continues to treat medical devices as secondary to pharmaceuticals, despite significant differences in their scientific, engineering, and regulatory requirements.

Industry's Call for Distinct Regulations

The medical device sector is advocating for regulations that align with international standards, such as those employed by the EU MDR, US FDA, and other global regulatory bodies. These frameworks focus on risk-based conformity assessments, quality management systems, and post-market surveillance rather than criminal penalties. Industry leaders argue that adopting a similar approach would better support the sector's growth and competitiveness on the international stage.

The draft bill's language, which includes terms like "adulterated," "spurious," and "misbranded," has also been criticized for its drug-centric focus. The industry fears that such terminology, coupled with the threat of imprisonment for non-harmful infractions, could stifle the innovation necessary for the sector's advancement.

Next Steps and Government Response

The draft bill is currently undergoing inter-ministerial consultation. It aims to replace the 86-year-old law governing pharmaceutical regulations in India. The government has yet to respond to the industry's concerns, but the opposition from key industry players underscores the need for a regulatory framework that recognizes the unique nature of medical devices.

As the consultation process continues, stakeholders are hopeful that the government will consider their feedback and make necessary adjustments to the draft bill. The outcome of these discussions will be crucial in shaping the future of India's medical device sector, which has the potential to be a significant contributor to the country's healthcare landscape and economic growth.