Medical Device Industry Opposes India's Draft Bill on Regulatory Grounds

India's medical device industry and healthcare organizations are voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which they argue incorrectly categorizes medical devices alongside pharmaceuticals. This, they claim, could stifle innovation, manufacturing, and investment within the sector.

Industry Concerns Over Regulatory Approach

The draft bill, currently under inter-ministerial review, aims to overhaul the 86-year-old law governing pharmaceutical regulations in India. However, industry representatives argue that the bill fails to recognize the fundamental differences between medical devices, which are engineering products, and pharmaceuticals. According to letters sent to the Union Health Minister, the bill's pharmaceutical-centric language and criminal penalties for regulatory lapses could hinder India's goal of becoming a global hub for medical device manufacturing.

Associations representing manufacturers, traders, healthcare providers, and patient safety groups have voiced their concerns. They argue that the bill's language includes terms such as “adulterated,” “spurious,” and “misbranded,” which are more appropriate for medicines, not devices. The industry warns that applying criminal penalties for issues like labelling errors, documentation lapses, and other non-harmful deviations is contrary to international practices.

Global Standards and Local Implications

Globally, medical devices are typically regulated through risk-based assessments, quality management systems, and post-market surveillance rather than criminal penalties. Countries like the EU, USA, Japan, UK, and Australia employ administrative enforcement for regulatory compliance, not imprisonment, the associations emphasize. The draft bill's proposal to impose prison sentences ranging from one to seven years for regulatory infractions is seen as excessively punitive.

The industry's feedback highlights that such stringent measures could deter investment and innovation, crucial for the sector’s growth. The draft, they argue, does not provide the necessary regulatory framework to support the expansion and global competitiveness of India's medical device sector.

Call for Rethink and Policy Adjustments

In their August 8 letter, the industry bodies urged the government to reconsider the draft's approach. They stressed the importance of distinguishing between pharmaceuticals and medical devices in regulatory language and enforcement. The associations believe that aligning the bill with international standards and practices will create a more conducive environment for growth and innovation in India's medical device industry.

As the draft bill undergoes consultation, the medical device sector is hopeful for revisions that will address their concerns and support the industry's development while ensuring patient safety and compliance with global norms.