Published Aug 15, 2026 | 8:00 AM ⚊ Updated Aug 15, 2026 | 8:00 AM
The industry's objections are particularly significant because Parliamentary committees had already examined the issue.
Synopsis: The 2026 Drugs, Medical Devices and Cosmetics Bill has triggered opposition from 11 medical-device associations, which say it ignores Parliament’s calls for a separate law and regulator. The industry argues the draft retains pharma-centric terminology, criminalises technical lapses and grants excessive inspector powers, risking investment, innovation and patient safety.
The Centre’s proposed Drugs, Medical Devices and Cosmetics Bill, 2026 has revived a long-running dispute over how India should regulate medical devices, with industry associations arguing that the government has ignored repeated recommendations from Parliamentary committees to create a separate law and institutional framework for the sector.
Eleven national associations representing medical-device manufacturers, traders, healthcare providers, hospitals, clinicians and patient advisory groups have jointly urged Union Health Minister JP Nadda to reconsider the draft, saying it continues to treat medical devices as an “adjunct to pharmaceuticals” despite fundamental scientific, engineering and regulatory differences between the two.
The associations have warned that the approach could undermine India’s ambition to become a global medical-device manufacturing hub, reduce import dependence and increase exports. They are seeking a standalone Medical Devices Act, an independent regulator and a risk-based regulatory framework aligned with international standards.
“India’s medical devices sector cannot be shackled by a pharma-centric law. Eleven national associations, backed by earlier recommendations from Parliamentary Committees, NITI Aayog, and WHO principles, urge the government to enact a standalone Medical Devices Act,” said Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD).
“Without this, India risks discouraging investment, innovation, and patient safety – undermining Make in India and Atmanirbhar Bharat,” Nath said.
The industry’s objections are particularly significant because Parliamentary committees had already examined the question of whether drugs and medical devices should be regulated through the same legislative framework.
The Parliamentary Standing Committee on Health and Family Welfare, in its 138th Report, had recommended that the government formulate separate legislation for medical devices rather than combining them with drugs and cosmetics.
The committee repeated the recommendation in its 146th Report, calling for separate legislation and a separate department for medical devices. The committee said drugs and devices both count as medical products, but devices differ from pharmaceutical products and need their own regulatory infrastructure and expertise.
The 2026 draft combines drugs, medical devices and cosmetics under one proposed law.
For the medical-device industry, this sits at the centre of the dispute.
The associations say they are not asking for less regulation. They want a system built around the nature and risks of medical devices, which range from syringes and surgical instruments to implants, diagnostic equipment and software-driven devices.
“Medical devices are engineering products, not pharmaceuticals. India must adopt smarter, risk-proportionate regulation that safeguards patients while fostering innovation,” said Prof Bejon Kumar Misra, Founder of the Patient Safety and Access Initiative of India Foundation.
The industry says its concerns are not new. When asked how much of the suggestions made by the sector in 2023 had been incorporated into the latest version, Nath said to South First: “Zero – no suggestion of strategic importance were incorporated.”
The industry backs the claim with a comparison of the medical-device provisions in the 2023 and 2026 drafts.
According to AiMeD’s comparison, several provisions remain identical: risk-based classification, post-market surveillance, the prohibition on misbranded, adulterated and spurious devices, import through designated ports, and restrictions on online sales. The association calls the change to licensing authorities cosmetic and says drug regulators keep control.
The association sums up its assessment in one line: “Chapter V of the 2026 draft is substantively identical to 2023, with expanded coercive powers and no structural reform toward an independent, engineering-aligned medical device regulatory framework.”
According to the industry, the issue goes beyond retained provisions. The regulatory approach has not changed, despite the concerns the sector raised and the recommendations Parliament made.
The industry objects to the use of pharmaceutical terminology in regulating medical devices.
The AiMeD submission objects to terms such as “misbranded”, “adulterated”, “spurious” and “not of standard quality”. It calls these pharma constructs rather than engineering concepts.
The association points to examples: an incorrect symbol, wrong font size, a software-version mismatch, incorrect Unique Device Identification placement or a packaging inconsistency.
“For devices, ‘misbranding’ may simply mean: Wrong font size; Incorrect symbol; Software version mismatch; Incorrect UDI placement; Packaging inconsistencies,” the submission says.
“Globally, these are administrative non-conformities, not criminal offences,” it adds.
The industry wants the law to use terms tied to safety, performance, engineering, software and usability requirements, instead of concepts built for pharmaceutical products.
In a separate clause-specific amendment proposal, AiMeD suggests replacing the terms “misbranded”, “adulterated” and “spurious” in the device provisions. It proposes requirements that devices meet safety and performance standards, meet engineering, software and usability standards, and carry no falsified or misrepresented components.
AiMeD’s analysis says the Bill provides for five to seven years’ imprisonment for adulterated or spurious devices causing grievous hurt, one to two years for certain spurious devices where there is no harm, and six months to one year for certain adulterated-device and licensing violations. It also flags mandatory fines of ₹3 lakh to ₹7 lakh and criminal exposure for directors, managers and partners.
The industry argues that this risks criminalising technical or administrative non-compliance.
“Licensing is an administrative control. Criminalising licensing lapses is unprecedented internationally,” the AiMeD submission says.
It raises a similar concern about documentation.
The submission points to the provision under which “misleading or wrong information” can attract imprisonment of not less than two years. According to AiMeD, the provision could cover post-market surveillance reporting errors, clerical mistakes, software-generated data issues or incorrect classification codes.
The association says administrative or civil mechanisms should handle these instead.
It also objects to criminal liability in disputes over compensation for injuries or deaths during clinical investigations, describing compensation disputes as civil matters.
The industry wants technical and documentation offences decriminalised, with administrative fines, recalls and corrective actions replacing imprisonment except where wrongdoing was intentional.
The association says imprisonment should be reserved for cases involving intentional fraud or deliberate concealment of safety risks.
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The proposed powers for medical-device inspectors have become a flashpoint.
AiMeD’s comparison says inspectors under the earlier framework had powers relating to search, seizure, collection of samples and examination of records. It says the 2026 draft adds powers to order immediate cessation and provides for arrest without warrant, subject to approval.
The industry describes this as a “significant escalation” and says a device regulator should exercise technical and administrative powers, not police powers.
AiMeD’s clause-specific proposal seeks deletion of the arrest provision and proposes instead that inspectors recommend proceedings to the appropriate law-enforcement authority in cases involving intentional fraud or deliberate concealment of safety risks.
“Inspector shall not exercise police powers; enforcement shall be administrative and technical in nature,” the proposed amendment says.
The association also wants a graded enforcement mechanism, in which an improvement notice and time for corrective action precede suspension. It says the exception should be cases involving imminent risk to patient safety.
The industry’s objections extend to the technical architecture of the proposed regulation.
For risk-based classification, AiMeD wants the law to refer to internationally harmonised principles and engineering standards, including IMDRF, ISO 13485, IEC 60601 and ISO 14971.
It also seeks a device-specific post-market surveillance framework involving manufacturer-led vigilance reporting, field safety corrective actions and device-specific incident reporting.
The association says the draft uses drug-style pharmacovigilance language instead of a system built around the lifecycle of medical devices.
The joint plea from the 11 associations also flags the omission of engineering concepts such as biocompatibility, usability engineering and software lifecycle safety.
The industry says this matters because medical devices now combine software, digital systems and implants. That puts lifecycle safety and performance at the centre of regulation.
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The associations link the regulatory debate to India’s push to expand domestic manufacturing.
AiMeD says India’s medical-device sector stays 70-80 percent import dependent, with an import bill of around ₹89,000 crore. It argues that the current framework could discourage domestic and foreign investment rather than encourage it.
The joint plea says the proposed framework risks undermining India’s ambition to become a medical-device manufacturing hub, reduce import dependence and take exports beyond ₹1 lakh crore over the next five to seven years.
The submission warns that criminalising engineering defects could discourage manufacturing investment. It says strict criminal liability could deter companies from abroad and add risk for SMEs and start-ups. It also argues that a gap with international regulatory norms could hurt exports.
Punit Bhasin, President of the Surgical Manufacturers & Traders Association, said the problem could hit smaller manufacturers hardest.
“Retaining medical devices under the same law as Drugs will create complex compliance requirements, particularly for MSMEs, potentially hurting competition, innovation and increasing healthcare costs. We urge the Government to establish a separate Act with an independent regulator,” Bhasin said.
The opposition brings together organisations representing medical-device manufacturers, diagnostic companies, healthcare providers, hospitals, surgical-device manufacturers, orthopaedic rehabilitation products, syringes and needles, and patient-safety and user groups.
Their demands go beyond changing individual provisions.
They want the government to set up an expert committee with representation from engineering, biomedical, clinical and patient-safety fields, followed by a separate Medical Devices Act aligned with international frameworks such as the EU MDR, US FDA and IMDRF.
They also want an independent National Medical Devices Regulatory Authority, with autonomy similar to regulators such as TRAI and IRDAI.
AiMeD’s own proposal calls for a Medical Devices Regulatory Authority separate from drug regulators and staffed with engineering, biomedical, clinical and industry expertise. The proposed authority would oversee regulation, conformity assessment, vigilance and enforcement.
The associations ask for structured consultation with manufacturers, clinicians, engineers and other stakeholders before the legislation moves forward.
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The latest plea followed the associations’ meeting with Health Minister JP Nadda at the Indian Medical Devices Conference at Vigyan Bhawan on 8 August.
The associations then submitted a written request for re-examination of the draft Bill. They say they want a structured consultation process to address concerns with the proposed framework.
The joint plea states the concern this way: the associations say the Bill, in its current form, treats medical devices as an adjunct to pharmaceuticals “despite clear scientific, engineering, and regulatory distinctions.”
They say the issue comes down to the type of regulatory system India chooses as it expands domestic production.
“India’s medical devices sector cannot be shackled by a pharma-centric law,” Nath said. “Without this, India risks discouraging investment, innovation, and patient safety – undermining Make in India and Atmanirbhar Bharat.”
The government’s response to the industry’s latest objections was not available in the material reviewed for this report.
For the industry, the dispute is not whether medical devices should be regulated. It is under what kind of law they should be regulated.
The associations want medical devices governed through a separate framework built around risk classification, engineering standards, lifecycle safety and proportionate enforcement, with criminal sanctions reserved for intentional wrongdoing.
AiMeD’s submission calls for the 2026 draft to be deferred until a stakeholder-consulted medical-device framework is developed. It says the Bill in its current form is “pharma-centric, criminalisation-heavy, and misaligned with global norms” and warns that it could discourage investment, increase import dependence and undermine Make in India.
Its closing line states its position: “India needs a separate, engineering-aligned Medical Devices Act, not a drug-dominated statute.”
