DoP Initiates Revision Of GTE Exemption List Of Medical Devices Amid Push For Self-Reliance And Patient Access

The Department of Pharmaceuticals (DoP) under the Union Ministry of Chemicals and Fertilisers has initiated a review of the existing Global Tender Enquiry (GTE) Exemption List for medical devices.

The move follows a series of representations from industry bodies, procurement agencies, healthcare institutions and multinational manufacturers seeking additions, deletions and modifications to the list.

At the heart of the review lies a policy challenge: how to strengthen the government's "Make in India" agenda while ensuring that hospitals and healthcare institutions continue to have access to critical devices that may not yet be manufactured domestically in adequate quantities or to the required specifications.

The GTE exemption mechanism occupies a crucial space within India's public procurement framework. Under the Public Procurement (Preference to Make in India) Order, government agencies are required to prioritise procurement from domestic manufacturers. However, where suitable products are unavailable within the country, ministries and departments are permitted to procure them globally through a Global Tender Enquiry.

The exemption list identifies medical devices that can be procured through such global tenders without being subjected to mandatory local procurement requirements.

The latest review indicates that stakeholders remain divided on the scope of these exemptions.

According to documents released by the Department, the domestic medical device industry has sought the renaming of 37 products currently included in the exemption list, the deletion of 52 devices and either the renaming or deletion of six additional products from the existing list of 354 exempted medical devices.

Industry representatives have argued that some products currently listed for global procurement are now being manufactured within India and therefore no longer require exemption from local procurement norms. In several cases, stakeholders have also suggested revised nomenclature to better define product specifications and facilitate procurement of higher-quality equipment.

Many of these representations have come from domestic manufacturers, industry associations, the Directorate General of Health Services (DGHS) and the Federation of Indian Chambers of Commerce and Industry (FICCI).

However, procurement agencies and multinational medical technology companies have presented a contrasting view.

They have sought the inclusion of approximately 320 additional medical devices in the exemption list, arguing that many of these products remain unavailable from Indian manufacturers or are not produced according to the technical specifications required by tertiary care hospitals.

Several healthcare institutions have also supported these requests, citing concerns over uninterrupted access to specialised devices used in critical care, advanced diagnostics and life-saving interventions.

Stakeholders advocating expansion of the exemption list have argued that patient care should remain the primary consideration, particularly in areas where dependence on imported technology continues to be high.

The current GTE exemption list of 354 medical devices, notified in 2024 and valid until March 2027, was developed through a rigorous and consultative process involving all relevant stakeholders, said Pavan Choudary, Chairman, Medical Technology Association of India (MTaI).

“The guiding principle behind GTE exemptions has been to ensure patient access to medical technologies that are not yet adequately manufactured in India. Many MTaI members manufacture in India and strongly support the growth of domestic manufacturing. MTaI believes products that are available locally in sufficient quantities and at the required quality standards can be procured domestically. However, where advanced technologies are not manufactured in India or domestic capacity is insufficient to meet clinical needs, continued GTE exemptions remain essential."

“While the 2024 exercise was largely comprehensive, a few advanced technologies that are not manufactured in India were missed out in the exemption list. We welcome the current review and hope it results in a complete, evidence-based framework that accurately reflects manufacturing realities and patient needs.”

“Any exclusion of technologies that are not adequately available in India risks limiting patient access to critical medical innovations and could adversely affect healthcare outcomes,” added Choudary.

The Department has now invited comments and objections from all stakeholders, including domestic manufacturers, importers, procurement agencies, healthcare institutions and industry associations.

To facilitate evidence-based decision-making, the Department has sought detailed supporting information on domestic manufacturing capacity, the number of Indian manufacturers, annual production capabilities, import dependence, availability of alternative suppliers, regulatory approvals, applicable standards and certifications.

Stakeholders have also been asked to assess the likely impact of proposed changes on public procurement, patient access, affordability, product availability and quality of healthcare services.

The official added the review is intended to ensure that exemptions are granted only where genuinely required and that procurement policies remain aligned with the evolving capabilities of the domestic industry.

The exercise assumes significance against the backdrop of India's broader ambition to reduce import dependence in the medical device sector. Despite recent growth, India continues to import a substantial proportion of high-end medical devices, including advanced imaging systems, specialised implants and sophisticated diagnostic equipment.

The government's procurement preference policy, introduced through the Public Procurement (Preference to Make in India) framework, was designed to encourage local manufacturing, generate employment and build indigenous technological capabilities.

Under the existing guidelines, public procurement agencies are required to source products from Class-I local suppliers, which have at least 80 per cent local content, and Class-II local suppliers, which have local content exceeding 50 per cent. Non-local suppliers fall below these thresholds.

However, policymakers have also recognised that healthcare procurement cannot be driven solely by localisation objectives. In situations where domestic manufacturers are unable to meet quality requirements, volume demands or specialised technical specifications, global procurement remains necessary to ensure uninterrupted patient care.

Comments and objections on the proposed amendments can be submitted to the Department of Pharmaceuticals until July 15, 2026, said the official.