NEW DELHI: The domestic medical device industry, along with hospitals and healthcare providers, has urged govt to re-examine the Draft Drugs, Medical Devices & Cosmetics Bill, 2026.“The Bill in its present form, does not provide the regulatory foundation required for India’s medical devices sector to grow, innovate, and compete globally”, an industry expert told TOI.The draft aims to repeal the existing Drugs and Cosmetics Act, 1940, and consolidate laws related to import, manufacture, distribution and sale of drugs, medical devices and cosmetics, to ensure their quality, safety and efficacy.In a letter to govt, the associations say that the draft bill, in its current form, treats medical devices as an adjunct to pharmaceuticals, despite clear scientific, engineering, and regulatory distinction between the two.Medical devices are engineering products, and should not be clubbed with pharmaceuticals, the letter says, adding the draft Bill continues to use drug-centric terminology such as “adulterated”, “spurious”. “misbranded”, and applies pharma-style criminalisation to engineering deviations.Globally, medical devices are regulated through risk-based conformity assessment and quality management systems.Further, the Bill does not provide for a dedicated regulatory authority for medical devices, despite repeated recommendations.In 2023, the Association of Indian Medical Device Industry argued that proposed overarching legislation (such as the Drugs, Medical Devices and Cosmetics draft) fails the domestic sector by continuing to regulate medical devices as “drugs” under a joint framework, instead of establishing an independent, specialized regulatory body.Administrative enforcement including recalls, corrective actions, civil penalties– should replace imprisonment for technical lapses, the letter by 11 associations including Aimed, AHPI (Association of Healthcare Providers India), ADMI (Association of Diagnostics Manufacturers) and Patient Safety and Access Initiative, says.
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The Bill 2026 applies uniform penalties across all device classes, from low-risk surgical instruments to high-risk implants, contrary to global norms.It does not clearly recognise key medical device standards covering areas such as biocompatibility, usability and software safety.While the draft has been circulated to various ministries and departments, key stakeholders, including industry associations, manufacturers and hospital bodies, have not been adequately involved in the process, the industry executive said, adding it appears inconsistent with the pre-legislative consultation process.
