Medical Device Industry Challenges Draft Bill's Pharma Approach

India's medical device industry is voicing strong opposition to the Draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes treating medical devices in the same regulatory framework as pharmaceuticals. Industry experts argue that this approach could significantly impede innovation and investment in the sector.

Industry Concerns Over Regulatory Approach

The draft bill has drawn criticism from various stakeholders, including manufacturers, healthcare providers, and patient safety groups. They have expressed concerns in communications to the Union Health Minister, highlighting the negative impact such regulations could have on manufacturing and India's aspirations to become a global hub for medical devices.

According to industry representatives, medical devices are fundamentally different from pharmaceuticals, being engineering products rather than chemical compounds. The draft bill, however, continues to employ pharmaceutical terminologies such as "adulterated," "spurious," and "misbranded," which are not suitable for medical devices, they argue.

Potential Impact on Innovation and Investment

Critics of the draft bill warn that equating medical devices with pharmaceuticals could deter investment and innovation in the field. The bill proposes criminal penalties, including imprisonment for labeling errors and documentation lapses, which industry stakeholders argue is excessive. This approach contrasts with international practices where administrative enforcement is the norm, as seen with regulatory bodies like the EU MDR, US FDA, and others.

The draft's stringent penalties, ranging from one to seven years of imprisonment even for non-harmful errors, are seen as particularly harsh. Industry representatives are advocating for a risk-based regulatory framework that aligns with global standards, emphasizing quality management systems and post-market surveillance rather than punitive measures.

Calls for Reevaluation of the Draft Bill

The medical device sector is calling for a reevaluation of the draft bill, suggesting that its current form does not foster the necessary regulatory environment for growth and competitiveness. Associations have emphasized the need for distinct regulatory guidelines that recognize the unique nature of medical devices.

As the draft bill undergoes inter-ministerial consultations, the medical device industry remains hopeful that their concerns will be addressed to ensure a balanced and supportive regulatory framework that encourages innovation and positions India as a leader in the global medical device market.