Medical Device Industry Opposes India's Draft Bill for Pharma-Like Regulations

The Indian medical device industry, alongside patient safety groups and healthcare providers, has voiced strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. Critics argue that the bill, which treats medical devices similarly to pharmaceuticals, could impede manufacturing and innovation efforts in the country.

Industry Concerns Over Regulatory Approach

In a letter addressed to the Union Health Minister, various associations representing manufacturers, traders, and patient groups have urged a reconsideration of the draft bill. They caution that the proposed regulations could deter investment and undermine India's potential as a global hub for medical devices. The industry's primary contention is that medical devices, fundamentally engineering products, should not be subjected to the same regulatory framework as pharmaceuticals.

According to industry insiders, the draft bill does not establish a suitable regulatory framework for the growth and international competitiveness of India's medical devices sector. The letter highlighted that the bill continues to conflate medical devices with pharmaceuticals, disregarding significant scientific and regulatory differences. The use of pharmaceutical-centric terms such as "adulterated," "spurious," and "misbranded" in the draft is a point of contention, as is the application of criminal penalties for regulatory infractions typical of pharmaceutical oversight.

Comparisons with Global Standards

The draft bill proposes penalties ranging from one to seven years of imprisonment for errors including labeling mistakes, documentation lapses, and engineering defects, even in the absence of harm. Industry stakeholders argue that this approach is not aligned with international practices. They cite regulatory frameworks such as the European Union Medical Device Regulation (EU MDR), the U.S. Food and Drug Administration (FDA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA), and the Australian Therapeutic Goods Administration (TGA), which favor administrative enforcement over criminal penalties.

These international models focus on risk-based conformity assessments, quality management systems, post-market surveillance, and recalls rather than imprisonment for regulatory infractions. The Indian industry emphasizes that adopting a similar approach would be more appropriate to foster growth and innovation in the sector.

Call for a Revised Regulatory Framework

The medical device industry is advocating for a regulatory framework that acknowledges the unique nature of medical devices and supports innovation. The associations have called for a risk-based regulatory approach that aligns with global standards, ensuring that India's medical device sector can thrive and compete on an international scale. The draft bill is currently under inter-ministerial review, and the industry hopes that their concerns will prompt a revision that better supports the sector's development.

The government's initiative to update the 86-year-old law governing pharmaceuticals is seen as a necessary step, but industry representatives stress the importance of distinguishing between pharmaceuticals and medical devices in the regulatory landscape.