India's Medical Device Sector Pushes Back Against Draft Bill
The medical device industry in India challenges the draft bill equating devices with pharmaceuticals, citing regulatory concerns.
The Indian medical device industry, alongside healthcare providers and patient safety groups, has voiced strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. The draft legislation, which seeks to regulate medical devices in the same manner as pharmaceuticals, has sparked concerns about its potential impact on manufacturing, investment, and innovation within the sector.
Industry's Concerns Over Proposed Regulation
Industry leaders argue that the draft bill's approach fails to recognize the distinct nature of medical devices, which are engineering products rather than pharmaceutical items. The bill's current language includes terms like "adulterated," "spurious," and "misbranded," typically associated with drug regulations, and imposes criminal penalties for regulatory lapses. These measures, industry representatives argue, are inappropriate for the medical device sector and could stifle growth and innovation.
In a letter dated August 8, addressed to the Union Health Minister, various associations representing manufacturers, traders, and healthcare providers have called for a reconsideration of the bill. They warn that the legislation, if enacted in its current form, would deter investment and undermine India's aspirations to become a global hub for medical device manufacturing.
Global Standards and Regulatory Practices
The medical device industry points out that internationally, devices are regulated through risk-based assessments, quality management systems, post-market surveillance, and recalls, rather than through criminal penalties. This approach is standard in regions such as the European Union, United States, Japan, United Kingdom, and Australia. The draft bill, however, proposes imprisonment ranging from one to seven years for issues such as labeling errors or documentation lapses, even in cases where no harm has occurred.
Industry stakeholders emphasize that aligning India's regulatory framework with global standards is crucial for fostering a competitive and innovative environment. They argue that the draft bill's current provisions do not provide the necessary foundation for the sector's growth and could hinder its ability to compete on a global scale.
Call for Rethink and Industry Engagement
As the draft bill undergoes inter-ministerial consultation, the medical device industry is calling for greater engagement and consultation with key stakeholders. They advocate for a regulatory approach that acknowledges the unique characteristics of medical devices and supports the sector's development.
The draft bill represents an effort to update the 86-year-old law governing pharmaceuticals in India. However, industry leaders caution that without significant revisions, the proposed legislation could have unintended negative consequences for one of the country's burgeoning industries.