Medical Device Industry Challenges Draft Regulation Bill in India
Industry groups argue draft bill threatens innovation by equating devices with drugs.
India's medical device sector is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that its provisions could stifle innovation and deter investment. Industry stakeholders, including manufacturers and healthcare providers, have expressed concern that the bill treats medical devices as pharmaceuticals, potentially imposing severe penalties for regulatory infractions.
Industry Concerns Over Regulatory Approach
The draft legislation has sparked controversy by proposing criminal penalties for issues such as labeling errors and documentation mishaps, with possible imprisonment ranging from one to seven years. Critics argue that this approach is inappropriate for medical devices, which are fundamentally engineering products rather than pharmaceutical ones. They highlight that globally, medical devices are governed through risk-based assessments and quality management rather than punitive measures.
In a letter to the Union health minister, industry associations emphasized the potential negative impact on India's burgeoning medical device sector. They warned that the proposed regulations could undermine the country's ambition to become a global hub for medical device manufacturing and innovation.
Calls for a Distinct Regulatory Framework
The draft bill has been criticized for using pharmaceutical-centric language, including terms like "adulterated" and "spurious," which are seen as inappropriate for medical devices. Industry leaders have pointed out that in other major markets such as the EU, US, Japan, and Australia, regulatory frameworks for medical devices focus on compliance and quality management rather than criminal penalties.
Advocates for the industry are calling for a separate regulatory framework that acknowledges the distinct nature of medical devices. They argue that the current approach could dissuade international investment and hinder the sector's growth prospects.
Draft Bill Under Review
The draft bill is currently under inter-ministerial review, and its future remains uncertain as stakeholders continue to lobby for changes. The government aims to replace the existing 86-year-old law governing pharmaceuticals with this new legislation, but the pushback from the medical device industry suggests that further consultation and revision may be necessary.
As the debate continues, the medical device sector remains hopeful that a more tailored regulatory framework will emerge, one that supports innovation while ensuring safety and compliance without resorting to punitive measures.