Medical Device Industry Challenges India's Draft Bill on Regulations
India's medical device sector opposes a draft bill equating devices with drugs, citing potential 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 regulating medical devices in a manner similar to pharmaceuticals. Industry representatives argue that such an approach could stifle innovation, deter investment, and hinder the country's ambition to become a global leader in the medical device market.
Industry Pushback Against Pharmaceutical Regulation Model
Key industry stakeholders, including associations representing manufacturers, healthcare providers, and patient safety groups, have formally expressed their opposition to the draft bill. In a letter to the Union Health Minister dated August 8, they highlighted that the proposed regulations do not differentiate between medical devices and pharmaceuticals, despite their distinct scientific and engineering characteristics.
The draft bill, currently under inter-ministerial review, seeks to replace the existing 86-year-old law governing pharmaceutical regulations in India. However, industry groups warn that treating medical devices as an offshoot of pharmaceuticals is a misstep. They argue that the bill's language, which includes terms like "adulterated," "spurious," and "misbranded," is more suited to pharmaceutical products and not appropriate for the engineering-focused nature of medical devices.
Concerns Over Penal Provisions
The draft bill proposes stringent penalties, including imprisonment ranging from one to seven years for issues such as labeling errors, documentation lapses, and licensing problems, even in cases where no harm occurs. Industry representatives argue that these punitive measures are not in line with international norms, pointing out that regions like the EU, US, Japan, UK, and Australia favor administrative enforcement over criminal penalties.
According to the letter, global regulations for medical devices focus on risk-based conformity assessments, quality management systems, post-market surveillance, and product recalls. The Indian draft bill's criminalization of what are essentially engineering deviations could deter innovation and discourage manufacturers from operating in India.
Call for a Revised Regulatory Framework
The medical device industry is advocating for a regulatory framework that reflects the unique nature of medical devices and aligns with international standards. They emphasize the need for a distinct regulatory path that encourages growth and innovation within the sector.
The draft bill's current form, they argue, lacks the necessary foundation to foster a competitive and innovative medical device industry in India. The associations urge the government to reconsider the bill's provisions to better support the sector's development and India's aspirations in the global medical device market.