The Indian medical device industry criticises the proposed overhaul of the drugs law, citing outdated terminology and lack of consultation, amid ongoing debates on specialised regulations for medical devices.
A draft law meant to replace India’s decades-old drugs regime has drawn sharp resistance from the country’s medical device industry, which says the proposal still treats devices as if they were simply another form of medicine. The bill, which is being circulated among ministries, would overhaul the Drugs and Cosmetics Act of 1940, but industry groups argue it remains too close to earlier versions rejected after consultation rounds in 2022 and 2023. According to the Indian Express, the Association of Indian Medical Device Industry has written to Union Health Minister J P Nadda warning that the text does not give the sector a regulatory framework suited to modern devices, innovation or global competition.
At the centre of the dispute is whether medical devices should be regulated under the same language and logic used for pharmaceuticals. The association says the draft wrongly uses drug-sector terms such as “spurious” and “misbranded” for devices, while also exposing manufacturers to criminal penalties for issues such as labelling mistakes, paperwork errors or engineering flaws that cause no harm. It also says the bill fails to create a separate regulator staffed with engineers and omits device-specific concepts such as biocompatibility, usability engineering and software lifecycle safety. Industry representatives quoted by the Indian Express said the latest draft is largely unchanged from previous versions and that none of more than 30 suggested revisions was accepted.
The objections are also procedural. Trade bodies say the government did not properly consult them while preparing the draft, despite official claims that feedback had been sought earlier. One industry expert told the Indian Express that consultation in 2022-23 produced thousands of comments, but that reviewing them was not the same as accepting any of them. The association wants a new drafting committee that includes engineering experts, clinicians, biomedical specialists, industry representatives and patient safety groups, and says that a structured consultation process should take place before any final version is approved.
The wider policy backdrop goes back several years. In 2016, the government withdrew an earlier amendment bill and said it was working on separate laws for drugs and for medical devices, a move presented as a way to modernise regulation while improving ease of doing business. In 2021, the Centre set up an eight-member panel under the Drugs Controller General of India to prepare a fresh draft, and in 2022 the health ministry circulated a new bill for feedback. The latest backlash suggests that, despite those earlier efforts, the central dispute remains unresolved: whether medical devices should be governed by a dedicated framework or kept under a law built for pharmaceuticals. Industry critics say the current draft would also give inspectors unusually broad powers, including the ability to halt activity or make arrests in some cases, which they argue could encourage overreach rather than better compliance.
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