Industry Pushback: Medical Devices Not Pharmaceuticals, Firms Oppose Bill

The Indian medical device industry is voicing strong objections to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that the proposed legislation risks stifling innovation and investment by treating medical devices as pharmaceuticals. Industry representatives, patient safety advocates, and healthcare providers have expressed concerns that the bill's approach could hinder India's ambitions to become a global hub for medical devices.

Industry Concerns Over Regulatory Approach

Several associations, representing a wide spectrum of stakeholders from manufacturers to patient groups, have formally communicated their reservations to the Union health minister. They argue that medical devices, fundamentally engineering products, should not be regulated under the same framework as drugs. The draft bill's language, which includes terms such as "adulterated," "spurious," and "misbranded," is seen as misaligned with the nature of medical devices.

The associations' letter, dated August 8, highlights that the draft bill does not establish a conducive regulatory environment for the growth and innovation of India's medical device sector. The bill's provisions for criminal penalties, including imprisonment for documentation errors and labelling mistakes, are particularly contentious. Industry leaders argue that such measures are not in line with international standards, where administrative actions are typically preferred over criminalization.

Global Standards and Risk-Based Regulation

Globally, medical devices are regulated using risk-based conformity assessments, quality management systems, and post-market surveillance. In contrast, the draft bill proposes penalties ranging from one to seven years of imprisonment for various regulatory lapses, even in the absence of harm. This approach starkly contrasts with practices in regions like the European Union, the United States, and Japan, where regulatory frameworks focus more on compliance and corrective actions rather than punitive measures.

The medical device sector's pushback comes as India seeks to update its 86-year-old pharmaceutical regulations. However, stakeholders argue that lumping medical devices with pharmaceuticals under the same regulatory umbrella could discourage investment and manufacturing, ultimately affecting the country's competitiveness in the global market.

Call for a Separate Regulatory Framework

The industry is advocating for a distinct regulatory framework that acknowledges the unique characteristics of medical devices. By differentiating between drugs and devices, stakeholders believe that India can foster a more supportive environment for innovation and global competitiveness. The associations are urging the government to consider international best practices and adapt a regulatory approach that aligns with the specific needs and dynamics of the medical device sector.

As the draft bill undergoes inter-ministerial consultations, the medical device industry remains hopeful that their concerns will be addressed. The outcome of this legislative process will be critical in shaping the future of India's medical device industry and its role on the global stage.