2026 (8) TMI 864
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....6. The applicant has requested for ruling on Levy of IGST on Bulk drugs or Active Pharmaceutical ingredient (API) under Customs Tariff Act, 1975. 1.1. The applicant in their application, submitted as follows: APPLICANT'S ELIGIBLITY FOR ADVANCE RULING AND WHY IT IS MAINTAINABLE BEFORE THE CAAR S. No Requirement under the Customs Act How it is met in the present case 1. Section 28E(b) defining advance ruling The Applicant in the present case is seeking a written decision on the questions as referred to in Section 28H of the Customs Act, 1962, in terms of Section 28E(b). 2. Section 28E(b) read with Section 28H enabling the nature of questions for which answer is sought The present application is being made in prescribed format and the question on which advance ruling is sought is with respect to applicability of Notification issued in respect of duties under the Customs Tariff Act, 1975 and Integrated Goods and Services Tax Act, 2017. 3, Section 28E(c) defining applicant The applicant holds a valid IEC Code granted under Section 7 of the Foreign Trade (Development and Regulation) Act, 1992 (22 of 1992). 4. Section 28I (2) (prov....
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....s manufactured from bulk drugs [other than those specified at nil at S. No. 113 of notification No. 10/2025-Integrated Tax (Rate) dated 17th September, 2025] 1.7. SI. No. 113 of Notification No. 10/2025-Integrated Tax (Rate) dated 17th September, 2025 is extracted below: SI. No. Chapter/Heading/Sub- heading/Tariff item Description of goods 113 30 or any Chapter Drugs or medicines listed in Annexure I 1.8.The above is the entry applicable for IGST at NIL rate. The products for which the present ruling is sought are not covered under Annexure 1, therefore the same is not applicable in the present case. 1.9.The bulk drugs/API in question are imported after procuring the following licenses under the Drugs and Cosmetics Act, 1940: Form No. I License No. Title of License Issued Illustrative Copy enclosed herewith Form 10 License to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, 1945 Licence No. IL/BD-014316 Form 11 Licence to import drugs for the purposes of examination, test or analysis Licence No. SW/OD/11/2025/0000012873 1.10. The Applicant has been importing the Bulk Drugs/API in questi....
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....d 17.09.2025 1.17. The bulk drugs/API in question satisfy all the above conditions. The fulfilment of each Condition is dealt with in detail in Grounds C to E below. C. Condition i: The entry is applicable to goods irrespective of the classification adopted for the goods under any chapter. Chapter 30 is merely indicative and goods (ailing luuler al lv chapter can fall under this entry. C.1. As per SI. No. 226 of the Schedule 1, drugs and medicines classified under any Chapter fall under its ambit and are subject to levy of JGST@5%. The bulk drugs/AP! in question are generally classified under Chapter 28 or 29. It is clear that these bulk drugs/API, even if not classified under Chapter 30, still fall under the ambit of the entry as it is applicable to drugs and medicines of any Chapter. Therefore, the first condition is met. D. Condition ii: From a combined reading of definitions of bulk drugs and drugs under various laws and literature, it is clear that the "All Drugs and medicines" is inclusive of bulk drugs and hence, levy of IGST in terms of 'Sl. No. 226 of Schedule I to the Notification shall apply to bulk drugs. D.1. It is submitted that the term....
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....n of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board; (emphasis supplied) D.3 Thus, from a combined reading of the definition of bulk drugs under the Drugs (Price Control) Order, 2013 and the definition of drugs under the Drugs and Cosmetics Act, 1940, it is clear that that "drugs" includes substances used as components of a drug i.e. as an ingredient of a drug. When even a gelatin capsule is treated as a drug, it goes without saying that the API on account of which the final medicine is effective, too is nothing but a drug. D.4 Furthermore, under the Drugs and Cosmetics Act and Rules, for import of a bulk drug, the importer needs to procedure numerous licenses and registrations which are applicable to drugs. That is, for purpose of licensing under the Drugs laws of India, bulk drugs are treated as drugs only. This is evident from the following licenses/ registrations issued to the Applicant for import of bulk drugs/API: Form No and Licence/Registration Issued under Section / Provision |Relevant extra from the Section/Provision ....
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.... a drug, used to treat disease or injury." Dictionary of Medical Terms (fourth edition) * drug. a natural or synthetic chemical substance which is used in medicine and affects the way in which organs or tissues function * medicine. a preparation taken to treat a disease or condition, especially one in liquid form Stedman's Medical Dictionary: * drug. 1. Any substance employed as a medicine in the treatment of disease. D.9 Thus, it is clear that the term "drugs" generally includes all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings; and also include substances intended for use as components of a drug. Therefore, it is submitted that bulk drugs/API should also fall under the ambit of drugs only. Even as per judicial precedents, the term "drugs" is inclusive of bulk drugs D.10 It is submitted that there is plethora of decisions that hold that the term "drugs" is inclusive of "bulk drugs". The Tribunal in Burroughs Wellcome (I) Ltd vs Commissioner of C. Ex. and Cus., Mumbai [2007 (216) E.L.T. 522 (Tri-Mum)], in the context of exemption benefit for life saving drugs, held t....
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....classified the goods as 'bulk drugs' under SI. No. 43(B), the assessees classified them as life saving drugs under SI. No. 43 (A). The Tribunal accepted the assessees contention and held that the drugs imported by them were to be categorized under SI. No. 43(A) inasmuch as they found mention in List 2. It was further held that, as SI. No. 43 (A) was more beneficial than 43 (B), the assessee was not precluded from claiming such benefit at a later stage. It is settled law that, where two exemption Notifications are applicable to a given goods which is otherwise chargeable to duty, the assessee is entitled to avail the benefit of that Notification which is more beneficial vide Indian Oil Corporation Ltd. v. CCE - 1991 (53) 347 (Tribunal), CCE v. Indian Petrochemicals - 1997 (92) E.L.T. 13 (S.C.) and H.C.L. Ltd. v. CC - 2001 (130) E.L.T. 405 (S.C.). Applying the same principle, we hold the view that, if two entries in an Exemption Notification are applicable to a given goods, the assessee can legitimately claim under the more advantageous entry. Therefore, we are inclined to follow, with approval, the view taken by the co-ordinate Bench in the case of Burroughs Wellcome (I) Ltd....
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...., in the present case when the notification also does not define drugs or bulk drugs/API, and nor does it make a specific distinction between the two, it is submitted that the interpretation that bulk drugs/API are drugs should be adopted. Reliance in this regard is placed on the Tribunal decision in Aurobindo Pharma Ltd. v. CCE, Hyderabad-I [2009 (247) E.L.T. 206 (Tri. - Bang.)], wherein it was held that when the notification does not distinguish between bulk drugs, drugs or medicines, then exemption is to be granted is to bulk drugs/API as well. D.17 Further, reference is also made to the recent decision of the Hon'ble CESTAT, Ahmedabad in the case of Shri Baser v. CCEx & St - 2024 (12) TMI 270 wherein reliance was placed on the decisions of Cipla Ltd (supra) and Hetero Drugs Ltd. v. CC (Airport) - 2017 (9) TMI 1275-CESTAT Chennai to hold that drugs and bulk drugs are one and the same. Thus, the exemption benefit under SI. No. 108(A) of Notification No. 12/2012-Cus dated 17.03.2012 was extended to the alleged bulk drugs imported by the Company. The relevant portion of the said decision is extracted hereunder: "4.1 On examination of the case on merit of M/s Sterlli....
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....his Ruling squarely covers the issue at hand and in the context of Notification No. 9/2025-Integrated Tax (Rate) dated 17.09.2025 has clearly held that benefit of 5% IGST under SI. No. 226 of the Notification is available to Bulk drugs/API imported into India as well. The Ruling covers import for further manufacture, as well as for clinical trials, and holds that in both cases IGST applicable on import will be 5% only. (Enclosed as 'Exhibit - D'). The relevant extract from the Ruling is as below: "7.11 To sum up: i) The definition of "drug" under Section 3(b) of the Drugs and Cosmetics Act, 1940 is wide and inclusive in nature, and expressly covers substances intended for use as components of a drug. Active Pharmaceutical Ingredients (APIs) / bulk drugs, being pharmaceutical substances used as such or as ingredients in formulations, squarely fall within the ambit of the said definition. ii) On a conjoint reading of the definition of "active pharmaceutical ingredient / bulk drug" under the Drugs (Price Control) Order, 2013 with the definition of "drug" under Section 3(b) of the Drugs and Cosmetics Act, 1940, and the definitions of "bioavailability ....
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....gly." Restricting the entry to cover only drugs and medicines for final consumption would render the entry to be redundant D.21 From a perusal of the entry, it is clear that it covers the following: (a) all drugs and medicines; (b) salts and esters of such drugs and medicines; (c) diagnostic test kits; and (d) formulations manufactured from bulk drugs/API. D.22 The usage of the semi colon (;) between "all drugs and medicines including their salts and esters and diagnostic test kits" and "formulations manufactured from bulk drugs" indicated that these are two separate items covered under the entry. D.23 Reliance is placed on the Tribunal decision of Hari and Co. v. Collector of Customs, 1991 (53) E.L.T. 336, wherein the semi-colon was interpreted to separate the former group from the latter group. The decision was maintained by the Supreme Court in Collector of Customs v. Hari and Co., 1997 (96) E.L.T. 503 (S.C.). Reference is also made to the Tribunal's decision in Heildelberg Cement (India) Ltd. v. Commr. of C. Ex., Nagpur & Raigad, 2015 (315) E.L.T. 53 (Tri. - Mumbai), wherein it was held clauses separated by a semi-colon are to....
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....The relevant extract of the said judgement is as follows: "Even apart from the opening words in Section 2 referred to above, it is well settled that where the context does not permit or where it would lead to absurd or unintended result, the definition of an expression need not be mechanically applied. [Vide T.M. Kanniyan v. Income Tax Officer, Pondicherry and Anr. 1968 20 S.C.R. 103, Pushpa Devi and Ors. v. Milkhi Ram (Dead) by his L.R.s. MANU/SC/0149/1990 : [1990]1SCR278 [para 14] and Commissioner of Income Tax, Bangalore v. J.H. Gotla, Yadagiri MANU/SC/0126/1985: [1985]156ITR323(SC) ." D.29 Therefore, the entry should be interpreted in such a manner that it is not rendered redundant. Accordingly, the term "drugs" should also cover bulk drugs/API. D.30 In fact, prior to Notification No. 9/2025 (Integrated Tax Rate), the earlier Notification was Notification No. 1/2017 (Integrated Tax Rate). SI. No. 180 Schedule I of the Notification was akin to the present Notification entry. The same is extracted below: S. No. Chapter/ Heading/ Sub- heading/ Tariff item Description of Goods 180. [30 or any chapter] Drugs or medicines including their salts and est....
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....xtracted below: "2. Definitions .- (1) In these rules, unless the context otherwise requires,- *** (e) "bioavailability study" means a study to assess the rate and extent to which the drug is absorbed from a pharmaceutical formulation and becomes available in the systemic circulation or availability of the drug at the site of action; (f) "bioequivalence study" means a study to establish the absence of a statistically significant difference in the rate and extent of absorption of an active ingredient from a pharmaceutical formulation in comparison to the reference formulation having the same active ingredient when administered in the same molar dose under similar conditions *** (j) "clinical trial" in relation to a new drug or investigational new drug means any systematic study of such new drug or investigational new drug in human subjects to generate data for discovering or verifying its,- (i) clinical or; (ii) pharmacological including pharmacodynamics, pharmacokinetics or; (iii) adverse effects, with the objective of determining the safety, efficacy or tolerance of such new drug or investiga....
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....mitted that in case of any ambiguity in the interpretation of the IGST Rate Notification, such as various applicable entries, it should be interpreted in favour of the taxpayer. Reliance in this regard is placed on the Tribunal decision of Samsung India Electronics Pvt. Ltd. v. Principal Commissioner of Customs, New Delhi, 2025 (7) TMI 229 - CESTAT New Delhi. The relevant portion of the decision is extracted below: "The Principal Commissioner, however, in paragraph 43 of the impugned order considered the IGST Rate Notification as an Exemption Notification and observed that the benefit of the IGST Rate Notification should be interpreted strictly and the burden to prove applicability would rest upon the tax payer and that the benefit of any ambiguity in the Notification must be interpreted in favour of the Revenue. The Principal Commissioner committed an error in assuming that the IGST Rate Notification is an Exemption Notification. The IGST Rate Notification is at rate Notification and, therefore, a Taxing Notification. It has to be strictly construed and any ambiguity has to be interpreted in favour of the tax payer and against the Revenue as was observed by the Supreme Co....
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....xhibit - F'. * "Drugs" includes bulk drugs by relying on definition under the Drugs (Prices Control) Order 1995 * Customs Tariff provides a similar concessional rate of 5% (by way of exemption notification), and bulk drugs used in the manufacture of drugs are also covered. Customs Notification is worded in the same manner as the GST rate Notification - thus relevant for consideration. Squarely applicable in the present case as it has examined the definition of "drugs". 3. In Re: Sterling Biotech Ltd., 2021 (1) TMI 372 - AAR, Guj. Enclosed as 'Exhibit - G'. * Only medicines and drugs are covered under the entry. * Bulk drugs are raw materials and cannot be directly administered to a human being. * The concessional rate of GST is applicable only to the medicine or drugs, which are ready for administering in the human being or person. * The word "Bulk Drugs" would have been included in the entry had the intention of the Government been to extend the benefit of concessional rate to the bulk drugs/raw material. The rulings are not applicable in the present case as they have not considered the complete definition of "drugs". They have only considere....
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....leviable for the import of bulk drugs/API? Applicant's Understanding: Not applicable. 2. Comments of the Port Commissionerate: 2.1 The comments of the Jurisdictional port Commissionerate have been received vide letter dated 22.07.2026 from the Office of the Principal Commissioner of Customs, ACC (Import), Delhi, and are as follows: 2.1.1. Eligibility of the applicant, in terms of Section 28E(c) of the Customs Act, 1962 to seek such advance ruling: Yes, M/s Copmed Pharmaceuticals Private Limited is a valid applicant within the meaning of Section 28E(c) (i) of the Customs Act, 1962, having IEC Code 0507013611. 2.1.2. Applicability of proviso (1) of section 28-I (2) of the Customs Act, 1962 regarding the question raised in the application: As per records available with this office, the question raised by the Applicant in the instant application is not, at present, pending in any proceeding in the Applicant's own case before any officer of Customs, the Appellate Tribunal or any Court, nor has it already been decided in any such proceeding. 2.1.3. Specify whether the claim of the applicant regarding the nature of activity, i.e. it is ong....
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.... medicines including their salts and esters and diagnostic test kits; formulations manufactured from bulk drugs [other than those specified at nil at S. No. 113 of notification No. 10/2025- Integrated Tax (Rate) dated 17th September, 2025] 2.3. On a plain reading, SI. No. 226 of Schedule I covers: (a) all drugs and medicines; (b) salts and esters of such drugs and medicines; (c) diagnostic test kits; and (d) formulations manufactured from bulk drugs. The entry is, thus, description-based and is not confined to any single Chapter, since it expressly extends to 'any Chapter'. 2.4. Nature of the Goods and Whether 'Bulk Drugs/APIs' Fall Within 'All Drugs and Medicines': 2.4.1. The terms 'drug' and 'bulk drug' are not defined under the Customs Act, 1962, the Customs Tariff Act, 1975, or the IGST rate notifications. Recourse is therefore required to be taken to the statute governing the goods, namely the Drugs and Cosmetics Act, 1940, read with the Drugs (Price Control) Order, 2013. 2.4.2. Section 3(b) of the Drugs and Cosmetics Act, 1940 defines 'drug' to include: i. all medicines....
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....e of finished formulations or for testing, clinical trial, bioavailability or bioequivalence purposes, since such studies are themselves statutorily governed under the New Drugs and Clinical Trials Rules, 2019 and are integral to the drug-approval process. The stage or purpose of use at the time of import does not alter the intrinsic statutory identity of the goods as 'drugs'. 2.5.1. Interpretation of SI. No. 226 - Effect of the Semicolon and 'Any Chapter': SI. No. 226 uses the expression 'All Drugs and medicines including their salts and esters and diagnostic test kits; formulations manufactured from bulk drugs'. The semicolon demarcates two distinct limbs: (i) all drugs and medicines (including salts, esters and diagnostic kits); and (ii) formulations manufactured from bulk drugs. Thus, the qualifying words "manufactured from bulk drugs" are confined to the second limb and do not curtail the scope of the first limb, which covers all drugs and medicines. Applicability to Bulk Drugs/APIs - Bulk Drugs/APIs are covered under the first limb, namely, "all drugs and medicines including their salts and esters". A Bulk Drug....
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.... position was applied to an identically structured IGST Rate Notification by the Tribunal in Samsung India Electronics Pvt. Ltd. v. Principal Commissioner of Customs, New Delhi [2025 (7) TMI 229-CESTAT New Delhi]. Accordingly, even assuming any residual ambiguity as to whether SI. No. 226 covers Bulk Drugs/APIs, such ambiguity would fall to be resolved in favour of the Applicant. 2.8. Judicial Precedents Holding that 'Bulk Drugs' are 'Dru 'Drugs': The proposition that 'bulk drugs' are 'drugs', for the purpose of description-based duty/tax entries that do not expressly exclude them, is supported by a consistent line of Tribunal decisions: Burroughs Wellcome (I) Ltd. v. Commissioner of C. Ex. and Cus., Mumbai [2007 (216) E.L.T. 522 (Tri .- Mum.)] and Cipla Ltd. v. Commissioner of Customs, Chennai [2007 (218) E.L.T. 547 (Tri .- Chennai)]. These decisions consistently hold that where an exemption/rate entry uses the expression 'drugs' without express exclusion of bulk drugs, no artificial distinction between 'drugs' and 'bulk drugs' can be introduced - a position further affirmed in Aurobindo Pharma Ltd. v. CCE, Hy....
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....a. Form 11 Import Licence for 'Isotretinoin' formulation (brand name Roaccutane): From a perusal of the quantity to be imported mentioned on the licence, it is clear that the licensed product is a finished formulation as it mentions 33 packs containing 30 capsules each. Whereas, the form 11 licence for Isotretinoin enclosed in the application, is evidently for bulk drugs as it mentions the quantity as "20 kg". Therefore, the difference between a licence for a finished formulation vs a licence for API / bulk drugs is evident. b. Form 28 Manufacturing Licence (along with renewal letter) c. Illustrative licence for list of products approved for manufacture under Form 28. From a perusal of the above documents, it is evident that API / Bulk drugs are different from formulations which are manufactured by the Applicant. The formulations may be a mixture of drugs and have excipients added to them etc. Further, the form of imported product is different as API / bulk drugs are loose products in bulk quantities, whereas formulations are in the form of tablets, capsules, vials, etc. 5. Findings, Discussion & Conclusion: 5.1 Having examined the CAAR-1 applicat....
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....ate Potassium + Silicon Dioxide (1:1) I.P. Form 11 is regarding "Licence to import drugs for the purposes of examination, test or analysis" in respect of drug named Isotretinoin. From the above produced licenses, it is evident that these are form for import of drugs named Clavulanate Potassium +Microcrystalline Cellulose (1:1) I.P .. Clavulanate Potassium + Silicon Dioxide (1:1) I.P. and Isotretinoin for the purposes mentioned therein. 5.3.2.1. From a plain reading of the aforesaid licences, it is evident that each licence is issued in respect of the specific drug(s) expressly mentioned therein and authorizes their import only for the purpose and subject to the conditions stipulated in the respective licence. Thus, the licences are product-specific. 5.3.2.2. I further observe that the applicant has furnished only one Form 10 and Form 11 as illustrative documents. These licences relate only to the above-mentioned drugs and do not establish that similar licences have been issued in respect of every bulk drug proposed to be imported by the applicant. 5.3.3. The applicant has submitted Form 28 Manufacturing Licence along with renewal letter and Illustrative licence for list....
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....l substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes;] (ii) such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette; (iii) all substances intended for use as components of a drug including empty gelatin capsules; and (iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board; From the above definition of drug it is evident that drugs cover: * all medicines for internal or external use; * all substances intended for diagnosis, treatment, mitigation or p....
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....pharmaceutical formulation and becomes available in the systemic circulation or availability of the drug at the site of action; (f) "bioequivalence study" means a study to establish the absence of a statistically significant difference in the rate and extent of absorption of an active ingredient from a pharmaceutical formulation in comparison to the reference formulation having the same active ingredient when administered in the same molar dose under similar conditions *** (j) "clinical trial" in relation to a new drug or investigational new drug means any systematic study of such new drug or investigational new drug in human subjects to generate data for discovering or verifying its, - (i) clinical or; (ii) pharmacological including pharmacodynamics, pharmacokinetics or; (iii) adverse effects, with the objective of determining the safety, efficacy or tolerance of such new drug or investigational new drug;" 5.4.5. I observe that a combined reading of the definitions of "drugs". "bioavailability study", "bioequivalence study" and "clinical trial" makes it evident that the term "drugs" is wide enough to include product....
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....uthority for Advance Rulings, Mumbai, in the case of M/s Cipla Limited [Ruling No. CAAR/Mum/ARC/161,162/2025-26 dated 17.03.2026], has held that Bulk drugs/Active Pharmaceutical Ingredients (APIs), whether imported for manufacture of formulations or for testing, clinical trials, bioavailability or bioequivalence studies, qualify as "All Drugs" under SI. No. 226 of Schedule I to Notification No. 9/2025-Integrated Tax (Rate) dated 17.09.2025, provided they are not covered under SI. No. 113 of Notification No. 10/2025-Integrated Tax (Rate). 5.7. Interpretation of SI. No. 226 of Notification No. 09/2025-Integrated Tax (Rate) dated 17.09.2025 5.7.1. SI. No. 226 of Schedule I (5%) reads as under: SI. No. Chapter/Heading/ Sub-heading/Tariff item Description of goods 226. 30 or any Chapter All Drugs and medicines including their salts and esters and diagnostic test kits; formulations manufactured from bulk drugs [other than those specified at nil at S. No. 113 of notification No. 10/2025-Integrated Tax (Rate) dated 17th September, 2025] The presence of a semi-colon clearly demarcates two independent and distinct categories of goods, namely: (i) ....
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....ods answering to the description of drugs and medicines. 5.7.7. It is a well-settled principle of classification that where goods are covered both by a general (Chapter-based) entry and a specific (description-based) entry, the well-settled principle generalia speciali bus non derogant requires that the specific entry shall prevail. Accordingly, Bulk drugs or Active Pharmaceutical ingredients (APIs), though classifiable under Chapters 28 or 29 for tariff purposes, when they satisfy the description of "drug", are appropriately covered under SI. No. 226 for the purpose of determination of applicable rate of tax. The SI. No. 226 entry is a specific entry which will prevail over the general entry of "all organic chemicals other than gibberellic acid". 5.7.8. The applicant has furnished only one Form 10 and Form 11 as illustrative documents. These licences relate only to the above-mentioned drugs and do not establish that similar licences have been issued in respect of every bulk drug proposed to be imported by the applicant. As per SI. No. 226, all Drugs and medicines including their salts and esters and diagnostic test kits; formulations manufactured from bulk drugs [other than ....
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