The draft aims to repeal the existing Drugs and Cosmetics Act, 1940. (Representative Image) 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.Join conversationView All Comments →Share your thoughts in the commentsInsightfulAgreeDisagreeSkepticalConcerningPromisingWorth ReadingBig DevelopmentPost CommentBe respectful · TOI community guidelinesThe 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.Get the latest India News and Live updates. Download the TOI app.About the AuthorRupali MukherjeeA business journalist with around two decades of experience tracking key consumer-focussed sectors like consumer durables, retail, consumer goods, aviation, automobiles and advertising, as well as economic ministries of the Union government. Now, writes primarily on pharmaceuticals and healthcare, and on issues of consumer interest. Besides also looks at trends that are shaping consumer behaviour and the broad consumer landscape. \nYou can follow Rupali on Twitter@Rupalijee.Read MoreEnd of ArticleFollow Us On Social MediaVideosPrashant Kishor Promises Jobs For 10,000 Bankipur Youths After Ending BJP’s 30-Year Hold | WatchIndia’s Map Move Rattles China: What Naming 27 Places In Arunachal Means?Air India Phuket-Delhi Pilot’s Confirmatory Dope Test Reportedly Positive For Marijuana, Sources SayTamil Nadu Assembly Passes Anti-NEET Resolution As DMK, AIADMK And PMK Back Abolition DemandDelhi CM Fumes, Rekha Gupta Slams AAP MLA Over Viral Video; Eight AAP MLAs Marshalled OutKashmiri Pandit Employees Sent On Leave After Lashkar-Linked Threat Letter‘Amit Shah Jawab Do’ Vs ‘Rahul Gandhi Bhaago Mat’: NDA, Oppn Face-Off In Parliament’Booked Hotel Room, Strangled Daughters’: Inside Bengaluru Murder Shocker‘Ladakh Is Not Kaziranga’: Snow Leopard Safari Plan Sparks DebateAmit Shah To Speak On Student Protest Crackdown; Rahul Says ‘Not Interested In Fantasy Convos’123PhotostoriesBaasi roti is an excellent breakfast: 5 health benefits you probably didn’t know about5 life lessons by Swami Vivekanand every student must knowRed pigments to elaborate hair: Japan’s longest-ruling dynasty, the Yamato Era’s beauty secrets decodedWhere is Westeros in real? 9 places ‘House of the Dragon’ built its realm inIndependence Day 2026 ethnic ideas: Bollywood actresses to inspire your August 15 lookLung cancer is not only about smoking: Doctor explains the risks hiding in your air, home and daily routineExclusive – Khatron Ke Khiladi 15’s Ruhaanika Dhawan on being the youngest contestant, on-screen mom Divyanka Tripathi’s reaction to her stunts and moreBaluchari saree: The forgotten Bengali handloom that nearly disappearedKeto, Carnivore, High-Protein Diets: Can eating too much protein or too few carbs put your kidneys under stress?The tiaras of Brunei royals: A closer look at the lavish jewels behind their most iconic looks123Hot PicksMumbai rainNEET PG city intimation slipSlovenia Indian embassyJharkhand protestWeather AhmedabadAjit DovalIran warDelhi rainUP scholarshipTop TrendingCJPGurgaon Businessman Wife ArrestBengaluru Missing TechieBlinkit MumbaiHarbhajan SinghPune-Bengaluru Highway AccidentTelangana AccidentAbhijeet DipkeWeather TomorrowShakeel Noorani
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.
