Medical Device Industry Opposes Indian Draft Bill on Regulatory Grounds

The Indian medical device industry, along with healthcare groups, has voiced strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. Industry representatives argue that the bill's approach of categorizing medical devices on par with pharmaceuticals could stifle innovation and deter investment.

Industry Pushback Against Drug-Centric Regulations

Associations representing manufacturers, healthcare providers, and patient safety groups have collectively submitted their concerns to the Union Health Minister. They argue that the draft bill's framework, which imposes stringent pharmaceutical-like regulations on medical devices, is misaligned with the distinct characteristics of these engineering products.

The draft bill proposes criminal penalties for regulatory lapses similar to those in the pharmaceutical sector, including imprisonment for labeling errors and documentation issues. The industry contends this approach is not aligned with international practices, where administrative actions are typically favored over criminal penalties.

Concerns Over Impact on Innovation and Investment

The medical device sector fears that the proposed regulations could adversely impact India's ambition to become a global hub for medical device manufacturing. By treating medical devices as an adjunct to pharmaceuticals, the bill overlooks the unique scientific and engineering aspects that distinguish these products.

In their August 8 letter to the Health Ministry, industry leaders emphasized that the draft bill lacks the necessary regulatory foundation to support growth and innovation in the sector. They highlighted that terms such as "adulterated," "spurious," and "misbranded" are inappropriate for devices and that the focus should be on risk-based assessments and quality management systems.

Call for a Separate Regulatory Framework

The opposition to the draft bill is rooted in the industry's call for a regulatory framework that acknowledges the differences between medical devices and pharmaceuticals. Industry representatives argue for regulations similar to those in the EU, US, Japan, UK, and Australia, where conformity assessments and post-market surveillance are standard practices.

The draft bill is currently under inter-ministerial consultation, and the medical device sector hopes for a reconsideration that separates device regulations from pharmaceutical laws. This distinction, they argue, is crucial for fostering an environment conducive to innovation and international competitiveness.