Medical Device Industry Challenges Draft Bill's Pharma-Like Regulations

The medical device industry in India is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. Industry leaders and healthcare groups argue that the bill's approach to regulate medical devices similarly to pharmaceutical products could stifle innovation, deter investment, and negatively impact manufacturing.

Industry Pushback on Regulatory Approach

In a letter dated August 8, several associations representing manufacturers, traders, healthcare providers, and patient safety groups have urged the Union Health Minister to reconsider the draft bill. They emphasize that medical devices are fundamentally engineering products and should not be regulated in the same manner as drugs. The draft bill, they argue, fails to recognize the distinct scientific and regulatory frameworks that differentiate medical devices from pharmaceuticals.

The draft legislation, which is currently under inter-ministerial consultation, proposes to replace the existing 86-year-old law governing pharmaceutical regulations in India. However, the industry argues that the bill’s drug-centric language and the imposition of pharma-style criminal penalties could hinder the sector’s growth and India’s ambition to become a global hub for medical devices.

Concerns Over Criminal Penalties

A significant point of contention is the draft bill's provision for criminal penalties ranging from one to seven years of imprisonment for labeling errors, documentation issues, licensing problems, post-market surveillance (PMS) reporting mistakes, and engineering defects. Industry representatives highlight that such punitive measures are not standard practice in regions like the European Union, the United States, Japan, the United Kingdom, or Australia, where administrative enforcement is preferred over criminalization.

According to the industry, the draft bill uses terms like “adulterated,” “spurious,” and “misbranded,” which are traditionally associated with pharmaceuticals, thereby misaligning with the engineering nature of medical devices. Globally, medical devices are typically regulated through risk-based conformity assessments, quality management systems, post-market surveillance, and recalls, rather than through criminal penalties.

Call for a Distinct Regulatory Framework

The associations argue that the current draft does not provide the necessary regulatory foundation to support the growth, innovation, and global competitiveness of India’s medical device sector. They have called for a regulatory framework that acknowledges the unique characteristics of medical devices as distinct from pharmaceuticals.

The industry is advocating for a system that emphasizes quality management and risk assessment, rather than punitive measures, to ensure patient safety and product efficacy. The medical device sector believes that aligning regulations with international standards will better facilitate the industry’s growth and integration into the global market.

As the draft bill undergoes further consultation, industry stakeholders are hopeful that their concerns will be addressed, paving the way for a regulatory environment that fosters innovation and investment in India's medical device industry.