Indian Medical Device Industry Rejects Draft Bill Equating Devices to Drugs
Indian medical device firms oppose a draft bill treating devices like drugs, warning it threatens innovation and investment.
India's medical device industry, along with healthcare groups, has voiced strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which seeks to regulate medical devices in the same manner as pharmaceuticals. Industry representatives argue that such an approach could stifle innovation, deter investment, and hamper India's aspirations to become a global leader in medical device manufacturing.
Concerns Over Regulatory Approach
Industry stakeholders, including manufacturers and healthcare providers, have expressed their concerns in a letter to the Union Health Minister. They highlighted that the draft bill fails to recognize the fundamental differences between medical devices and pharmaceuticals. Unlike drugs, which are chemical-based, medical devices are engineering products and should be regulated accordingly. The letter warns that the bill's approach could discourage manufacturing and innovation within the sector.
The draft bill's language, which includes terms like "adulterated" and "spurious," traditionally associated with pharmaceuticals, has been criticized for being inappropriate for the medical device sector. Industry leaders emphasize that globally, medical devices are governed by risk-based assessments and quality management systems rather than punitive measures that include imprisonment.
International Standards and Industry Feedback
Comparing the proposed Indian regulations with international standards, stakeholders pointed out that regions like the European Union, the United States, Japan, and Australia focus on administrative enforcement rather than criminal penalties for regulatory lapses. The draft bill's provisions for imprisonment of one to seven years for issues such as labeling errors and documentation lapses are seen as excessive, particularly when no harm results from these issues.
The ongoing inter-ministerial consultation on the draft bill has prompted several trade associations and patient safety groups to call for a regulatory framework that supports growth and innovation. They argue that the bill, in its current form, does not provide the necessary foundation for the medical devices sector to thrive globally.
Call for a Distinct Regulatory Framework
As India aims to strengthen its position in the global medical device market, industry leaders are urging the government to establish a regulatory framework that acknowledges the unique nature of medical devices. The current draft is seen as a step back from India's goal of becoming a hub for medical device innovation and manufacturing.
The draft bill's potential impact on the sector has sparked a broader debate on how best to regulate medical devices while ensuring patient safety and fostering industry growth. Stakeholders are advocating for a balanced approach that aligns with global best practices and supports the industry's development.