Draft Drugs Law Faces Resistance From India’s Medical Device Industry

A proposed overhaul of India’s nearly nine-decade-old drugs law has run into strong opposition from the medical device industry, with manufacturers and healthcare bodies arguing that treating medical devices and pharmaceuticals under a common regulatory framework could create uncertainty, stifle innovation and expose companies to disproportionate penalties for minor technical lapses.

The Drugs, Medical Devices and Cosmetics Bill, 2026, which seeks to replace the Drugs and Cosmetics Act, 1940, is currently being circulated among stakeholder ministries for inter-ministerial consultation. But industry representatives have questioned both the substance of the draft and the consultation process, saying that concerns raised during earlier consultations have not been adequately addressed.

Eleven national associations representing medical-device manufacturers, traders and healthcare providers have jointly urged Union Health Minister J P Nadda to reconsider the draft and create a regulatory framework that recognises the distinct nature of medical technology.

The Association of Indian Medical Device Industry (AiMED) has separately written to the Health Minister, arguing that medical devices cannot be regulated as an extension of pharmaceuticals.

“(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… The draft continues to treat medical devices as an adjunct to pharmaceuticals, despite clear scientific, engineering and regulatory distinctions between the two categories,” the association said in its representation.

The industry’s concerns extend from terminology to enforcement powers and the proposed treatment of technical errors.

Device manufacturers have objected to the use of terms such as “spurious” and “misbranded”, traditionally associated with pharmaceutical products, arguing that a defect in a device may arise from engineering, software, electrical or design issues rather than deliberate adulteration or fraud.

Rajiv Nath, Forum Coordinator of the AiMED, said the sector was particularly concerned about criminalising technical and administrative lapses that may have no bearing on patient safety.

Among the examples cited by the industry are labelling mistakes, documentation deficiencies, software-generated errors, incorrect symbols, packaging inconsistencies and software-version mismatches.

The concern is that an inadvertent error could expose manufacturers or officials to criminal proceedings even where the product is safe and no patient has suffered harm.

The industry has also questioned whether such an approach is consistent with the government's broader Jan Vishwas reforms, which seek to decriminalise minor regulatory violations and promote ease of doing business.

Another contentious provision relates to the powers proposed for inspectors.

The industry representatives said the draft gives inspectors powers, subject to prescribed approvals, to direct the immediate cessation of a specified activity until compliance is achieved. The proposed legislation also contains provisions relating to arrest in cases involving adulterated or spurious drugs.

The medical-device sector fears that enforcement powers developed primarily around pharmaceutical regulation could be applied to technologically complex devices without adequate appreciation of their engineering and risk characteristics.

Nath said the industry has therefore sought a regulatory mechanism involving specialists in biomedical engineering, electronics, software, clinical practice and patient safety, as per the representation.

It has also proposed a committee comprising engineering experts, clinicians, biomedical specialists, industry representatives and patient-safety groups, separate from the group handling conventional drug regulation.

The demand comes at a time when India is seeking to build a stronger domestic medical-device industry and reduce its dependence on imports.

Medical technology today encompasses a vast range of products—from syringes and consumables to ventilators, implants, cardiac devices, imaging equipment, surgical systems and software-driven diagnostic technologies.

Their development and safety assessment can involve electrical engineering, software reliability, cybersecurity, materials science, biocompatibility, mechanical design and human-machine interaction.

Vishwaprasad Alva, Founder and Managing Director of Skanray Technologies, said the proposed approach reflected a deeper problem in the way medical technology was being viewed in policymaking.

“Putting Medtech and Pharma together just because they are both related to healthcare is like putting drones and helicopters under the Ministry of Agriculture because they are used in survey, crop planning, and pesticide spraying for farms,” he said.

Alva said the two sectors had fundamentally different business models, regulatory requirements and technology cycles, and that the distinction needed to be recognised in policy.

The concern is particularly relevant as India seeks to move beyond assembling or importing medical equipment towards developing indigenous products and technologies.

Unlike medicines, where the primary focus is on chemical or biological composition, medical devices can involve multiple disciplines. A software update, for instance, can affect the functioning of a diagnostic system, while the safety of an implant may depend on its material properties, mechanical performance and interaction with the human body.

Industry representatives have also called for a separate medical devices law aligned with international regulatory frameworks, including the European Union’s Medical Device Regulation and the US Food and Drug Administration’s device framework.

The sector has proposed graded penalties, corrective and preventive actions, product recalls and stronger post-market surveillance. Criminal sanctions, it argues, should be reserved for serious violations involving deliberate misconduct or risks to patients.

Such a system, industry representatives say, would also allow regulators to focus their resources on products and manufacturers that pose genuine safety concerns.

The consultation process has become another flashpoint.

Industry representatives said the current draft is substantially similar to versions circulated in 2022 and 2023, despite detailed comments submitted during the earlier exercise.

They have alleged that several recommendations made by the sector have not been incorporated.

The government has maintained that consultations were conducted during the earlier drafting process and that stakeholder comments were examined. The industry, however, is seeking another structured consultation before the legislation is finalised.

Alva said the policy approach had already created uncertainty for an industry that had otherwise been witnessing strong growth.