Medical Device Industry Challenges Draft Bill Over Pharma-Like Regulations

India's medical device industry, alongside healthcare groups and patient safety organizations, is voicing opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. The draft legislation, which aims to overhaul the country's pharmaceutical regulations, is criticized for subjecting medical devices to the same regulatory framework as pharmaceuticals, potentially stifling innovation and investment in the sector.

Industry Concerns Over Regulatory Approach

Industry representatives argue that medical devices, fundamentally engineering products, should not be regulated in the same manner as pharmaceuticals. They have expressed concerns that the bill's language and proposed penalties are more suited to drug regulations, referencing terms such as "adulterated," "spurious," and "misbranded." The draft bill includes severe penalties, including imprisonment for issues like labeling errors and documentation lapses, which the industry says is not the norm internationally.

In a letter addressed to the Union Health Minister, various associations highlighted that countries like the EU, US, Japan, UK, and Australia adopt administrative enforcement measures rather than criminal penalties for regulatory deviations in medical devices. They emphasized that a risk-based approach with conformity assessments and quality management systems is more appropriate for regulating medical devices.

Potential Impact on India's Medical Device Sector

Stakeholders warn that the draft bill could deter investment and manufacturing, undermining India's goals of becoming a global hub for medical devices. The associations pointed out that the current draft does not provide a conducive regulatory foundation for the sector to grow and compete on an international scale.

The draft, which is currently under inter-ministerial consultation, aims to replace an 86-year-old law governing pharmaceutical regulations in India. However, the medical device community insists that treating their products as an adjunct to pharmaceuticals ignores the distinct scientific and engineering differences between the two categories.

The debate highlights the ongoing challenge of crafting legislation that adequately addresses the distinct needs and characteristics of diverse healthcare products. The medical device industry is calling for a reconsideration of the draft bill to ensure regulations are aligned with global practices and conducive to innovation and growth.