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 The Medical Technology Association of India (MTAI) has welcomed the Department of Pharmaceuticals' (DoP) decision to review the Global Tender Enquiry (GTE) Exemption List of Medical Devices, stating that a few advanced technologies that are not manufactured in India were missed out in the exemption list.
The DoP has recently announced its plans to revise the existing Global Tender Enquiry (GTE) Exemption List of Medical Devices, for addition, deletion or renaming of products from the list in order to improve the procurement activities, while ensuring the interests of the domestic manufacturers are protected. It has sought the stakeholders to submit suggestions and objections on the revised list before July 15, 2026.
“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,” said Pavan Choudary, chairman, MTaI.
“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,” he added.
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.
Choudary said that 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. The Association 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," he opined.
As reported, under the revised list, the medical devices industry has requested rename 37 medical devices, delete 52, and either rename or delete six devices out of the list of 354 medical devices that are currently in the Global Tender Enquiry (GTE) exemption list, which are exempted from the mandatory local procurement clause of the Central government under the Public Procurement regulations.
The procurement agencies and global medical devices majors, meanwhile, has proposed addition of another 320 devices into the exemption list, pointing out various reasons including that these are essential for patient survival and some of them do not have an Indian manufacturer to produce them with the required specifications.
The request for renaming and deletion of products from the existing list has been filed by various parties, including the Directorate General of Health Services (DGHS), Federation of Indian Chambers of Commerce and Industry (FICCI), medical devices manufactures and manufacturers associations, for various reasons, including that renaming of some of these products are helpful to purchase better quality products, or that some of them have Indian manufacturers, thus making it viable to purchase from them rather than floating a global tender.
The request for addition of products has been filed by various stakeholders including purchasers like All India Institute of Medical Sciences (AIIMS), Jammu, international manufacturers like Siemens Healthineers, Bayer Pharmaceuticals, Abbott Healthcare, Philips India, Johnson & Johnson, Baxter India, Boston Scientific, BARD India Healthcare, among others.
Releasing both the lists, the DoP has invited all concerned stakeholders, including domestic manufacturers, importers, industry associations, procurement agencies, healthcare institutions, and other interested parties to submit their comments, views, or objections, if any, on the proposed amendments to the GTE Exemption List within July 15, 2026.
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