9911796707
TMI Blog2020 (10) TMI 1292X X X X Extracts X X X X X X X X Extracts X X X X ..... given by the applicant in Form ARA-01, the issue raised by the applicant is neither pending nor decided in any proceedings under any of the provisions of the Act, against the applicant. 4. As per statement of facts submitted by the applicant- (1) The applicant intends to get the said product manufactured under third party manufacturing by different vendors under drug license. The product would be supplied through pharma distribution channel i.e chemist shop or direct supplies to hospitals. (2) The Composition of Topical Antiseptic solution/Topical Antiseptic Hand sanitiser is as Under Chlorhexidine Gluconate Solution Ip 2.5% v/v Eq to Chlorhexidine Gluconate 0.5% w/v Ethanol IP 70% v/v Excipients q.s. (3) The said Topical Antiseptic solution/Topical Antiseptic hand Sanitiser is described on label as Chlorhexidine Gluconate and Ethanol Antiseptic Solution and topical antiseptic hand sanitiser that kills germs like bacteria, fungi molds and viruses . (4) Topical Antiseptic Solution/Topical Antiseptic hand Sanitiser cannot be used for general cleaning as it does not remove dirt, soil etc. (5) Topical Antiseptic solution/Topical Antiseptic hand sanitiser cannot ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... peripheral venous catheter. * Prepare clean skin with a >0.5% chlorhexidine preparation with alcohol before insertion of a central venous catheter or peripheral arterial catheter and during dressing changes. If there is a contraindication to chlorhexidine, use tincture of iodine, an iodophor or 70% alcohol. * Antiseptics should be allowed to dry according to the manufacturer's recommendation before placing the catheter." Pg no 100 D) "Bundle of care for prevention of CLABSI Skin cleaning with alcohol-based chlorhexidine (rather than iodine). Change dressings and disinfect site with alcohol-based chlorhexidine every5-7 days (change earlier if soiled)" Pg no 101" E) "Preparation of the surgical site: alcohol-based antiseptic solutions based on CHG(chlorhexidine) for surgical site skin preparation in patients undergoing surgical procedures (CHG is a better choice than povidone-iodine because of rapidonset and persistent antimicrobial activity)." Pg no 143 F) "Intraoperative factors Site preparation * Thoroughly wash and clean the surgical site to remove gross contamination before performing antiseptic skin preparation. * Use an appropriate chlorhexidine-alcohol b ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... croorganisms. It refers to substances applied on inanimate objects owing to their strong chemical properties. Chemical disinfectants are recommended for cleaning and disinfection only of frequently touched areas/surfaces by those who are suspected or confirmed to have COVID-19. Precautionary measures are to be adopted while using disinfectants for cleaning - like wearing gloves during disinfection." (5) The HSN Explanatory notes, common parlance, dictionary meaning and Ministry of health advisory all have one thing in common that disinfectants are strong chemicals used for disinfecting inanimate objects, inert surfaces and due to the presence of strong chemicals are not suitable for direct application on human/living tissue. Therefore Topical Antiseptic Solution/hand sanitiser "which is presented as fit for direct application on hands and skin cannot merit classification as disinfectant under heading 3808 94 00. Even the broader heading 3808 refers to substances like insecticides, fungicides, pesticides etc which are not regarded as fit for direct application on human body . Reliance is placed on decision of CEGAT in case of Bengal chemicals and Pharamceuticals (P ltd 1991 (53) E ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e of Hagel Capsules Inds. Ltd vs CCCE, Mumbai 2002 (142) ELT (599) (Tri Mumbai) maintained by Supreme Court 2003 (156) ELT A105. (9) It is pertinent to mention that both in case of ICPA supra and Hagel supra the products in question were similar to applicants product containing Chlorhexidine gluconate which is a known and well established antiseptic agent. The Antiseptics are distinguished from disinfectants as antiseptics are used to killing disease causing micro organism on living tissue where as disinfectants are used to kill micro organism on inanimate objects i.e. non living things /surfaces . therefore Topical Antiseptic solution/Topical antiseptic hand sanitiser merit classification under hs code 3004 90 87 and not under 3808 94 00. (10) Topical Antiseptic hand sanitiser is distinguishable from a hand sanitiser not having antiseptic ingredients . Presence of Active pharmaceutical substance Chlorhexidine gluconate (CHG ) which is a known antiseptic agent along with alcohol leads to superior antimicrobial action and is therefore recommended by various authorities for use by Doctors, health workers in operation theatres / ICU and various health settings for pre and post ope ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ubmitted by them. At the outset, we find that the issue raised in the application is squarely covered under Section 97(2)(a) of the CGST Act 2017 being a matter related to classification of goods. We therefore, admit the application for consideration on merits. 11. We observe that the applicant has sought advance ruling on the issue- (1) Whether 'Topical Antiseptic Solution/Topical Antiseptic Hand Sanitiser" is classifiable under HSN code 3004 90 87 (medicament) or 3808 94 00 (disinfectant). (2) What is rate of tax payable on 'Topical Antiseptic Solution/Topical Antiseptic Hand Sanitiser" under Cemtral Goods and Services Tax Act, 2017; Uttar Pradesh Goods and Service Tax Act, 2017? 12. As per Section 9(1) of the CGST Act, 2017, the levy of tax is on the supply of goods or services "at such rates" as may be notified by the Government on the recommendations of the Council. Accordingly, Notification No. 1/2017-Central Tax (Rate) dated 28-Jun-2017 has been issued to notify the rates. Entry No. 87 of Schedule III of the said notification which stipulates the rate of 18% reads as under: S.No Chapter/Heading/Sub-Heading/Tariff Item Description of Goods 87 3808 Insectic ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... tion that such goods shall be put up in forms or packings for retail sale or as preparations or articles. Further Rule 1 of rules for the interpretation provides that the classification shall be determined according to the terms of the headings and any relative Section or Chapter Notes. Now to determine the meaning of the term "disinfectants and similar products" as mentioned in the heading under 3808, we shall have to take recourse to the Explanatory Notes under HSN as issued by WCO. Supreme Court in the case of CCE v. Wood Craft Products Ltd. 1995 (77) E.L.T. 23 (S.C.) has approved the reference to the Explanatory Notes since the tariff is patterned on the HSN formulated by WCO for which the said notes are issued. Relevant portion of the said notes under heading 3808 in context of sanitizers is as under: "(IV) Disinfectants Disinfectants are agents which destroy or irreversibly inactivate undesirable bacteria, viruses or other micro-organisms, generally on inanimate objects. Disinfectants are used, for example, in hospitals for cleaning walls, etc., or sterilising instruments. They are also used in agriculture for disinfecting seeds and in the manufacture of animal feeds to ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... to treat an illness or to improve a person's health, rather than to prevent an illness. Similarly, the dictionary meaning of Prophylactic Uses is a substance or device used for preventing disease. In other words, to determine whether or not a product or a formulation is to be labelled as a 'medicament' it is necessary to consider its efficacy in treating or remedying an 'injury' an 'ailment' an 'illness' or a 'disease'. Hence, it becomes imperative to look into the definition of 'injury'. Miller-Keane Encyclopaedia and Dictionary of Medicine, Nursing, and Allied Health, Seventh Edition defines 'injury' as 'harm or hurt; usually applied to damage inflicted on the body by an external force'. Again, in Medical terms 'illness' or 'ailment' is often defined as 'a physical or mental disorder'. As such, the hand santiser is not a medicament being not used for treatment of illness or injury. 22. In Ciens Laboratories case {2013 (295) E.L.T. 3(S.C.)}, the Hon'ble Supreme Court has held that prior to adjudicating upon whether a product is a medicament or not, Courts have to see what the people w ..... X X X X Extracts X X X X X X X X Extracts X X X X
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