Indian Medical Device Industry Pushes Back Against New Draft Bill
Medical device groups oppose a draft bill likening devices to drugs, citing harm to innovation and investment.
The Indian medical device industry is raising concerns over the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes to regulate medical devices in a manner similar to pharmaceuticals. Industry leaders argue that this approach could stifle innovation, deter investment, and hinder India's ambitions of becoming a global hub for medical device manufacturing.
Industry Concerns Over Proposed Regulations
Various associations representing manufacturers, healthcare providers, and patient safety groups have expressed their opposition to the draft bill in a letter to the Union Health Minister. They warn that the proposed regulations would negatively impact manufacturing and investment in the sector. The primary contention is that medical devices, being engineering products, should not be subject to the same regulatory framework as pharmaceuticals.
The draft bill, which is currently undergoing inter-ministerial consultation, aims to replace the 86-year-old law governing India's pharmaceutical regulations. However, industry stakeholders argue that it fails to establish a conducive regulatory environment for the growth and innovation of India's medical devices sector.
Regulatory Differences Highlighted
In their correspondence dated August 8, industry representatives highlighted that the draft bill continues to use drug-centric language, employing terms such as "adulterated," "spurious," and "misbranded." The bill also proposes criminal penalties, including imprisonment for labeling errors and documentation lapses, which are typically addressed through administrative enforcement in other countries.
Industry leaders emphasize that globally, medical devices are regulated through risk-based conformity assessments, quality management systems, post-market surveillance, and recalls. They point out that regulatory bodies in the EU, US, Japan, UK, and Australia do not impose criminal penalties for such issues, instead relying on administrative actions to ensure compliance.
Call for Policy Rethink
The medical device sector is urging the government to reconsider the draft bill's provisions, advocating for a regulatory framework that recognizes the distinct nature of medical devices. They argue that adopting a more tailored approach would support the sector's growth and align with international best practices.
The draft bill's approach has raised alarms among stakeholders who fear it could deter international investment and discourage local manufacturing. The industry is seeking a regulatory environment that fosters innovation and positions India as a leader in the global medical devices market.