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2026 (2) TMI 945

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.... At the outset, we would like to make it clear that the provisions of the Central Goods and Services Tax Act, 2017 (the CGST Act, for short) and the West Bengal Goods and Services Tax Act, 2017 (the WBGST Act, for short) have the same provisions in like matter except for certain provisions. Therefore, unless a mention is specifically made to such dissimilar provisions, a reference to the CGST Act would also mean reference to the corresponding similar provisions in the WBGST Act. Further to the earlier, henceforth for the purposes of these proceedings, the expression 'GST Act' would mean the CGST Act and the WBGST Act both. 1.2 The applicant, Hi Care Remedy Private Limited is presently engaged in the manufacture of medical disposables and personal protective equipment. The applicant operates under Medical Device License No. MFG/MD/2022/000663, issued by the Central Drugs Standard Control Organisation (CDSCO), and is ISO 13485:2016 certified, demonstrating compliance with internationally recognized quality management standards for medical device manufacturing. The applicant's integrated manufacturing plant and warehouse facility is situated at Behala Industrial Estate, Kolkata, We....

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....ance ruling is sought for are found to be covered under clause (a) of sub-section (2) of section 97 of the GST Act. 1.5 The applicant states that the questions rose in the application neither have been decided by nor is pending before any authority under any provision of the GST Act. The Revenue has also agreed to the point. 1.6 The application is, therefore admitted. 2. Submission of the Applicant 2.1 The Applicant, is engaged in the manufacture and supply of medical-use gloves, personal protective equipment (PPE), imaging accessories, laparoscopy accessories, intraoperative cable covers, patient overcovering (procedure drapes), and patient undercovering (drape sheets). All these products are designed, manufactured, and supplied exclusively for use in hospitals, clinics, and healthcare institutions. 2.2 According to the applicant, each of the listed products is sterilized and individually packed in sealed sachets to preserve sterility until the point of use. The packaging bears mandatory medical device markings, license numbers, Instructions for Use (IFU), and storage conditions in compliance with regulatory requirements. 2.3 The products are exclusively marketed....

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....7 In view of the above submissions, the Applicant respectfully prays that the Authority may: I. Reclassify eligible products under HSN 9018 and HSN 6210 as applicable; and II. Provide specific guidance on the classification and GST rate applicable to HANDCARE(r) EVA Sterile and Non-Sterile Gloves. 3. Submission of the Revenue 3.1 The concerned officer from revenue expressed that the applicant's request to reclassify medical-use gloves, PPE, sterile covers, drapes and undercovers from HSN 3926 to HSN 9018 and/or 6210 is legally unsustainable, as the said reclassification would result in an unwarranted reduction of GST rate from 18% to 5%. It is contended that Heading 9018 covers only "instruments and appliances" used in medical sciences. Since GST law does not define these terms, reliance has been placed on dictionary meanings. Reference has been made to the Oxford Advanced Learner's Dictionary where the terms are defined as under: • Instrument - a tool or device used for a particular task, especially for specialist or scientific work • Appliances - a machine that is designed to do a particular thing in the home, such as preparing....

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....uments and evidences submitted by the applicant, it is a company that manufactures 1) medical examination gloves, 2) medical examination and personal protective gowns, 3) operation room shoe covers, 4) protective garments for incontinence and 5) medical examination probes covers and camera covers under the medical device licence issued by the proper authority. The material for all the products has been mentioned as 'non-latex' in the said licence. In respect of the above categories of goods the applicant manufactures the following commercial products as shown in the table below: Sl. No. Description of products in licence Commercial products manufactured by the applicant 1 Medical examination gloves Handcare sterile Eva gloves Handcare non-sterile Eva gloves 2 Medical examination and personal protective gowns Wearon sterile apron 3 Operation room shoe covers Cleancare OT shoe cover 4 Protective garments for incontinence Drape sheet 5 Medical examination probes covers and camera covers Clearprobe endocavity/ transvaginal probe cover General purpose ultrasound probe cover Lap....

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.... 2 Cleancare OT shoe cover 6210 3 Clearprobe endocavity/ transvaginal probe cover 9018 4 General purpose ultrasound cover 9018 5 Laparoscopy camera cover 9018 6 Interoperatvie cable cover 9018 7 cleansheet procedure drape 6210 8 Drape sheet 6210 The applicant has not suggested any HSN code for the commercial product named as Handacre sterile or non-sterile EVA gloves in addition to the above eight. 4.4 From the above facts and circumstances narrated and submissions made by the applicant the following points are noted: A) The goods in respect of which the application for advance ruling has been furnished are all non-latex products. B) The primary ingredient of all the products is plastic co-polymers. C) All these products are used in healthcare sector. D) The products are meant for maintaining a sterile environment inside the healthcare organisation. E) The applicant emphasises that the proper classification of the products should be done on the basis of their usages and not on the basis of the constituent elements. F) The products manufactured by the applicant ....

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.... For this we have to look at the General Interpretative Rules of the Harmonised System. The relevant portions of the said Interpretative Rules are reproduced as under: '2. (a) Any reference in a heading to an article shall be taken to include a reference to that article incomplete or unfinished, provided that, as presented, the incomplete or unfinished article has the essential character of the complete or finished article. It shall also be taken to include a reference to that article complete or finished (or falling to be classified as complete or finished by virtue of this Rule), presented unassembled or disassembled. (b) Any reference in a heading to a material or substance shall be taken to include a reference to mixtures or combinations of that material or substance with other materials or substances. Any reference to goods of a given material or substance shall be taken to include a reference to goods consisting wholly or partly of such material or substance. The classification of goods consisting of more than one material or substance shall be according to the principles of Rule 3. 3. When by application of Rule 2 (b) or for any other reason, goods....

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....se are not at all garments whatsoever. They all are made of polymers of plastics and hence are classifiable under HSN 39269099. In our considered view, the argument of the suggested inclusion of these products into HSN 6210 is not maintainable since they are not garments and they are not made up of fabrics of heading 5602, 5603, 5903, 5906, 5907. The above items may appear to be classifiable under HSN 621010, the specific entries being 62101010 [Personal protective garments for surgical and medical use (felt or non-woven) conforming to IS 17423] and 62101020 (surgical gowns and drapes conforming to IS 17334). But it should be taken into consideration that 621010 refers to garments, made up of fabrics of heading no. 5602 or 5603. These two headings refer to felt and man-made filaments. The applicant's products are made of plastics and polymers of plastics and do not qualify for garments from any consideration. So this classification is not applicable to the products as noted above. Handcare sterile and non-sterile EVA gloves: These items find specific entries under HSN 39262011 or 39262019 depending on whether it is disposable or not respectively. 4.8 There rema....

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....product. It can make a product more useful, efficient or decorative. • It is not a core component of a product. It is not the primary and essential part without which the main product will not function. The term and concept of accessory has been matter of judicial pronouncements since long. The concept of accessory has been the bone of contention in the following cases: The Deputy Commissioner of Agricultural Income-Tax And Sales Tax (Law), Board Of Revenue (Taxes), Ernakulam v. Union Carbide India Limited before the Kerala High Court Kores (India) Ltd., Kanpur v. State of U.P. before the Uttar Pradesh High Court N.A.V Naidu v. Commissioner of Commercial Taxes before the Karnataka High Court In all the above cases the respective High Courts underscored the principle that for an item to be classified as an accessory, it must not be essential for the functioning of the main product and should merely enhance its convenience or effectiveness. In the case of The Deputy Commissioner of Agricultural Income-Tax And Sales Tax (Law), Board Of Revenue (Taxes), Ernakulam v. Union Carbide India Limited, the Kerala High Court cit....