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The Department of Pharmaceuticals (DoP) is considering revision of the existing Global Tender Enquiry (GTE) Exemption List of Medical Devices, released in February, this year, 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.
Based on the list it has released, the Department received comments and representations from various stakeholders seeking amendments to the existing GTE Exemption List. The representations received primarily relate to the addition and deletion of medical devices from the GTE Exemption List, said the Department.
The medical devices industry has requested to 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.
Releasing both the lists, the Department of Pharmaceuticals (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.
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 Seimens Healthineers, Bayer Pharmaceuticals, Abvbott Healthcare, Philips India, Johnson & Johnson, Baxter India, Boston Scientific, BARD India Healthcare, among others.
The DoP has said that while submitting comments or objections, stakeholders should furnish relevant supporting information in the justification, including availability or non-availability of domestic manufacturing capacity, details and number of domestic manufacturers and importers, annual production and supply capacity within India, import dependence and availability of alternative sources, applicable standards, certifications, and regulatory approvals, procurement-related issues, if any, likely impact on public procurement, patient access, availability, affordability, and quality of healthcare services, and any other technical, clinical, regulatory, commercial, or procurement-related justification.
Comments or objections in the prescribed format should be submitted on or before July 15, 2026 through email to the medical devices department of the DoP, clearly mentioning “Comments/Objections on Proposed Amendments to the GTE Exemption List of Medical Devices”, in the subject of the email.
"Comments/objections received after the stipulated date or without adequate supporting information may not be considered," it added.
It may be noted that the DoP has issued a guideline on December 30, 2020, for implementing the provisions of Public Procurement (Preference to Make in India) Order (PPO), 2017, to encourage Make in India and promote manufacturing and production of goods and services related to pharmaceutical sector in India with a view to enhance income and employment.
Under the guideline, the public procurement agencies should purchase minimum local content for pharmaceutical formulations from Class I local suppliers - suppliers with local content equal or more than 80 per cent - and Class II local suppliers - with local content of more than 50 per cent but less than 80 per cent. Another categorisation as per the guideline is the non-local suppliers, who have local content less than or equal to 50 per cent.
However, considering that some of the goods of the required quality, specifications etc., may not be available in the country and it is necessary to also look for suitable competitive offers from abroad, the DoE amended the General Financial Rules, 2017 empowering the concerned ministry or department to seek tender globally through GTEs.
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