Medical Device Industry Opposes New Draft Bill Treating Devices as Drugs
India's medical device sector opposes a draft bill classifying devices as drugs, citing potential harm to innovation and investment.
The medical device industry in India is pushing back against the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which seeks to regulate medical devices in the same manner as pharmaceutical products. Industry stakeholders argue that this approach could stifle innovation, deter investment, and hinder India's aspirations to become a global hub for medical device manufacturing.
Concerns Over Regulatory Approach
Industry representatives, patient safety groups, and healthcare providers have voiced concerns that the draft bill does not differentiate adequately between pharmaceuticals and medical devices. They argue that medical devices are fundamentally engineering products and should not be regulated under the same framework as drugs. The draft's language, which includes terms like "adulterated," "spurious," and "misbranded," is perceived as inappropriate for the nuances of medical device regulation.
In an August 8 letter to the Union health minister, various associations highlighted that the draft bill's approach could negatively impact manufacturing and innovation. They stressed that the bill's punitive measures, including imprisonment for errors like labelling and documentation lapses, are not aligned with global practices. Instead, they advocate for risk-based conformity assessments and quality management systems, which are standard in regions such as the EU, US, and Japan.
Industry's Call for Reform
The draft bill is part of an effort to modernize India's pharmaceutical regulations, replacing a law that has been in place for 86 years. However, the medical device industry argues that the current draft fails to provide the necessary regulatory foundation for growth and competitiveness on a global scale. They emphasize the need for a distinct regulatory framework that recognizes the scientific and engineering distinctions of medical devices.
As the draft bill undergoes inter-ministerial consultation, industry stakeholders continue to lobby for changes that would prevent the imposition of pharmaceutical-style criminalization on the medical device sector. They warn that such measures could discourage international investment and impede India's goal of becoming a leader in the medical device industry.
The ongoing debate underscores the need for a nuanced approach to regulation that supports innovation and growth in the medical device sector while ensuring safety and compliance.