Medical Device Firms Challenge Draft Bill's Pharma-Like Regulations
India's medical device industry opposes a draft bill treating devices as pharmaceuticals, citing potential harm to innovation and investment.
The Indian medical device industry, alongside healthcare providers and patient safety advocates, is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. The bill proposes to regulate medical devices in a manner similar to pharmaceuticals, raising concerns about its potential impact on manufacturing, investment, and innovation within the sector.
Industry Concerns Over Regulatory Approach
Various associations representing manufacturers, traders, and healthcare providers have communicated their concerns to the Union Health Minister. In their correspondence, they argue that the draft legislation, by equating medical devices with drugs, could stifle growth in an industry that is distinct both scientifically and technologically from pharmaceuticals.
The industry groups assert that medical devices should not be subject to the same stringent regulatory framework as drugs, which includes language and penalties typically associated with pharmaceuticals, such as terms like "adulterated," "spurious," and "misbranded." They claim this approach could deter investment and hinder India's goal of establishing itself as a global hub for medical devices.
Call for Risk-Based Regulation
Critics of the bill emphasize that globally, medical devices are regulated through risk-based conformity assessments, quality management systems, and post-market surveillance, rather than through criminal penalties. The draft bill, however, suggests imprisonment of up to seven years for issues such as labeling errors and documentation lapses, even in cases where no harm has occurred.
The industry points to international practices in regions like the European Union, United States, Japan, United Kingdom, and Australia, where administrative enforcement is preferred over criminalization for regulatory compliance.
Potential Impact on Innovation and Investment
Industry stakeholders warn that the proposed regulations could discourage innovation and investment in India's medical device sector. The draft's current form is perceived as lacking the necessary regulatory foundation to support the growth and competitiveness of the sector on a global scale.
The draft bill is part of the government's initiative to update the nearly 86-year-old law governing pharmaceuticals in India. However, the medical device industry argues that a one-size-fits-all approach fails to recognize the unique characteristics and requirements of medical device regulation.
As the draft bill undergoes inter-ministerial consultation, the medical device sector continues to advocate for a regulatory framework that acknowledges the distinct nature of medical devices and supports their development and innovation.