Eleven national associations representing medical device manufacturers, traders, hospitals, clinicians and patient groups have raised concerns over the Draft Drugs, Medical Devices and Cosmetics Bill, 2026, saying it will regulate medical devices like medicines and could criminalise technical and labelling lapses even when no patient is harmed.
In a joint letter to Health Minister J.P. Nadda, the associations called for a separate Medical Devices Act, an independent regulator, risk-based penalties, and fresh consultation with engineers, clinicians and patient-safety experts.
“India’s medical devices sector cannot be shackled by a pharma-centric law,” said Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AiMeD), in a statement. He said that without a standalone Medical Devices Act, India risks discouraging investment, innovation, and patient safety.
The Bill seeks to replace the Drugs and Cosmetics Act, 1940, with a new law for drugs, medical devices and cosmetics. For the first time, it defines “medical device” in law and gives devices their own chapter, separate from drugs, on manufacture, import, sale, distribution and clinical investigation.
Medical devices are already regulated, but only by being treated as “drugs,” a practice that began with a handful of categories like cardiac stents and IV cannulae in the mid-2000s and expanded under the Medical Devices Rules, 2017. The 1940 Act has no separate provisions for devices. The new Bill changes that.
The proposed law will cover the manufacture, import, sale and distribution of drugs, medical devices and cosmetics. It also includes provisions for clinical trials of new drugs and clinical investigations of medical devices.
It also proposes to rename the Drug Controller General of India, or DCGI, as the “Drugs and Medical Devices Controller General, India,” reflecting the expanded role of the regulator.
Main objections
Contending that medical devices are products used to diagnose, prevent, monitor or treat diseases, such as implants, ventilators, syringes, diagnostic kits and surgical instruments, the associations say such devices need rules based on their design, intended use and risk.
Prof Bejon Kumar Misra, founder of the Patient Safety and Access Initiative of India Foundation, said that medical devices are “engineering products, not pharmaceuticals” and called for “smarter, risk-proportionate regulation” that protects patients while supporting innovation.
“The draft continues to treat medical devices as an adjunct to pharmaceuticals, despite clear scientific, engineering, and regulatory distinctions between the two categories,” the associations said in their letter.
One of their biggest concerns is the use of drug-style categories such as “adulterated”, “spurious” and “misbranded” for medical devices, with criminal penalties attached.
Under the draft, a medical device can be considered “misbranded” if it is not labelled or packed in the prescribed manner or carries a label, statement, design or device that makes a false claim.
AiMeD’s letter argues that the draft provides for imprisonment for certain labelling, documentation, licensing, post-market surveillance and engineering-related violations, including cases where no harm occurs.
The associations said that such non-intentional compliance failures should instead be dealt with through administrative penalties and corrective action. They have also called for penalties to be linked to the risk and classification of a device, rather than applying the same approach to low- and high-risk products.
‘Police-style powers’
Another point of friction is the enforcement powers proposed in the Bill. The draft allows a Drugs Inspector, with prior approval from a superior authority and reasons recorded in writing, to order the immediate stoppage of a specified activity until satisfactory compliance is demonstrated.
It also allows an inspector, with prior written approval from the regulator, to arrest without a warrant a person suspected of certain offences involving adulterated or spurious drugs.
The associations have described these as expanded “police-style powers” and said these could create uncertainty for medical device manufacturers. Enforcement should be proportionate to the risk posed by the device and the seriousness of the violation, they said.
Regulator for medical devices
The associations have urged the government to consider a standalone Medical Devices Act and an independent National Medical Devices Regulatory Authority.
The framework should draw from international models such as the EU’s Medical Device Regulation, the US FDA’s device framework and principles of the International Medical Device Regulators Forum, they said.
There should be a fresh expert committee involving engineers, biomedical specialists, clinicians, industry representatives and patient-safety groups, separate from the group working on drug regulation, according to the associations.
“Keeping medical devices under the same law as drugs could increase compliance requirements for Micro, Small, and Medium Enterprises (MSMEs),” said Puneet Bhasin, president, Surgical Manufacturers & Traders Association.
This, he added, can hurt competition and raise healthcare costs.
The associations have also pointed to earlier recommendations of Parliamentary Standing Committees and NITI Aayog that supported a separate regulatory framework for medical devices.
The associations have questioned whether their concerns were adequately considered before the draft was finalised. Versions of the proposed legislation were circulated to stakeholders in 2022 and 2023, and the government has said that comments received during those consultations were examined.
However, the medical device industry said the latest draft remains largely unchanged from those earlier versions and does not reflect the changes it had sought.
The draft does not adequately reflect inputs from manufacturers, hospitals, clinicians, patient groups and engineering experts, according to the letter. The associations have, therefore, sought fresh, structured consultations before the Bill is finalised.
