TaxTMI 
TaxTMI 
2026 (9) TMI 17
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.... a pharmaceutical company incorporated in 03.07.1991. The Applicant is a leading manufacturer and supplier of pharmaceutical products. 1.3. In connection with its business, the Applicant purchases and imports a wide range of Bulk Drugs after obtaining the requisite licence. The Bulk Drugs so imported are Active Pharmaceutical Ingredients (APIs). These imported ingredients are used for the manufacture of formulations i.e dosage form of drug and occasionally for testing, clinical research and Bioequivalence study. These imported ingredients, which are active ingredients for medicines, are hereinafter collectively referred to as "bulk drugs/API". 1.4. Bulk drugs/API are classified under Chapter 28 or Chapter 29 as they are organic and inorganic chemicals. The present application pertains to determination of IGST payable on the import of these bulk drugs/API. The relevant portion from the of the IGST Rate Notification (at SI. No. 226 of Notification No. 9/2025-Integrated Tax (Rate) dated 17th September, 2025) is extracted below: SI. No. Chapter/Heading/Sub- heading/Tariff item Description of goods 226. 30 or any Chapter All Drugs and medicines including their sa....
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....; 1.11. The Applicant herein has been granted a valid Importer-Exporter Code Number (IEC) under Section 7 of the Foreign Trade (Development and Regulation) Act, 1992. The same is 0593044312. 1.12. Clause (b) of Section 28E of the Customs Act defines 'advance ruling' as: (b) "advance ruling" means a written decision on any of the questions referred to in section 28H raised by the applicant in his application in respect of any goods prior to its importation or exportation; 1.13. The Advance Ruling sought is towards goods to be imported in future. The questions on which an application for an advance ruling can be made have been provided under Section 28H of the Customs Act. As per the said Section 28H (2) of the Customs Act, an applicant may make an application for advance ruling in respect of questions relating to: (a) applicability of notification issued in respect of duties under the Customs Act, 1962, the Customs Tariff Act, 1975 and any duty chargeable under any other law for the time being in force in the same manner as duty of Customs leviable under the Customs Act; 1.14. The present application is being made by the Applicant to confirm the....
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....India; (c) The application for advance ruling is in relation to clause (a) of Section 28H (2) of the Customs Act, 1962; and (d) The application is not barred under Section 28I of the Customs Act, 1962. QUESTION OF LEVY OF IGST ON THE IMPORT OF BULK DRUGS/API 1.18. The levy of IGST on imports into India follows from Section 3 (7) of the Customs Tariff Act, 1975. The relevant portion is extracted below: "SECTION 3. Levy of additional duty equal to excise duty, sales tax, local taxes and other charges. (7) Any article which is imported into India shall, in addition, be liable to integrated tax at such rate, not exceeding forty per cent. as is leviable under section 5 of the Integrated Goods and Services Tax Act, 2017 on a like article on its supply in India, on the value of the imported article as determined under sub-section (8) ^8 [or sub-section (8A), as the case may be." 1.19. IGST Rates are notified vide Notification No. 9/2025-Integrated Tax (Rate). The relevant portion of Schedule I (5%) to the IGST Rate Notification is extracted below: SI. No. Chapter/Heading/Sub- heading/Tariff item Description of goods 226. 30 or any Chapter....
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.... that the term "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. 1.26.1 It is submitted that the term "all drugs and medicines" is not defined under the Notification or under the Customs Tariff. Considering the nature of the products in question, the same should be interpreted by considering the relevant provisions under the Drugs Laws of India. Reference is made to the definitions under the Drugs (Price Control) Order, 2013. The relevant extracts are 'as below: "(b) "active pharmaceutical ingredients or bulk drug" means any pharmaceutical, chemical, biological or plant product including its salts, esters, isomers, analogues and derivatives, conforming to standards specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and which is used as such or as an ingredient in any formulation; *** "(i) "formulation" means a medicine processed out of or containing one or more drugs with or without use of any pharmaceutical aids, for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease and, but shall not i....
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....is evident from the following licenses/ registrations issued to the Applicant for import of bulk drugs: Form No and Licence/Registration under Section / Provision Relevant extracts from the Section/Provision Form 10 (Rule 23 of the Drugs and Cosmetic Rules, 1945, as amended) Rule 23 -Import licences. - An import licence in Form 10 shall be required for [import of drugs], excluding those specified in Schedule X, and an import licence in Form 10A shall be required for the import of drugs specified in Schedule X.] Form 11 (Rule 33 of the Drugs and Cosmetic Rules, 1945) Rule 33 - Import of drugs for examination, test or analysis. - Small quantities of drugs the import of which is otherwise prohibited under section 10 of the Act may be imported for the purpose of examination, test or analysis subject to the following conditions: - (a) no drug shall be imported for such purpose except under a licence in Form 11; *** Form CT -17 (Rule 68 to 72 of the New Drugs and Clinical Trials Rules, 2019) Rule 68 - Grant of licence for import of new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, tes....
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....is submitted that bulk drugs such as active pharmaceutical ingredients also fall under the ambit of drugs only. Even as per judicial precedents, the term "drugs" is inclusive of bulk drugs 1.26.10. 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 that the phrase can include bulk drugs as well. The Tribunal observed that the term life saving drugs was not defined in the exemption notification, but upon the term of "drugs" under the Drugs (Prices Control) Order included "bulk drugs", and accordingly the same was applied to the term life saving drugs. 1.26.11. The definition of "drugs" under the erstwhile Drugs (Prices Control) Order, 1995 was as below: "(i) "drug" includes:- (i) all medicines for internal or external use of human beings or animals and all 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 pr....
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....cial 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 approva!, the view taken by the co-ordinate Bench in the case of Burroughs Wellcome (I) Ltd .& Pfizer Ltd. 5. In the instant case, admittedly, the 'bulk drugs' imported by the appellants were specifically mentioned in List 3 appended to SI. No. 80(A) of Customs Notification No. 21/02 and are liable to be considered as 'drugs' mentioned at 80(A). It is beyond doubt that 'bulk drugs' are also 'drugs.' They are so defined under the Drugs (Prices Control) Order, 1995 also. The imported goods, which are specified in List 3, must fall within the coverage of drugs specified in List 3' and consequently the benefit of SI. No. 80(A) would be admissible to them in relation to BCD. It would follow that, insofar as CVD is concerne....
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....CEx & 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 Sterlling Biotech Ltd, we find that the dispute is on the exemption entry of the goods in question whether the same would fall under description (A) or (B) of Sr. No. 108 of Notification No. 12/2012-CUS. We find that description (A) grants exemption to drugs and medicines specified in the list No. 3 and 4 of Customs exemption Notification 12/2012-Cus and description (B) provides exemption to bulk drugs used in the manufacture of goods mentioned at (A). The point of dispute is only that whether the drug mentioned at description (A) covers the bulk drugs manufactured by the appellant namely Idarubicin hydrochloric acid, Doxorubicin hydrochloric acid, Daunorubicin hydrochloric acid, E....
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.... 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 study", "bioequivalence study" and "clinical trial" under the New Drugs and Clinical Trials Rules, 2019, it is evident that APIs, even when imported for testing, bioequivalence, bioavailability or clinical research purposes, retain their statutory character as "drugs" and are not excluded merely on account of their stage or purpose of use. iii) APIs are regulated and licensed as "drugs" by the Central Drugs Standard Control Organization (CDSCO) under the statutory framework of the Drugs and Cosmetics Act, 1940 and the New Drugs and Clinical Trials Rules, 2019, including for import under Forms 10 and CT-17. Their regulatory recognition as drugs reinforces their statutory character. iv) Judicial precedents and....
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....or 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 be read disjunctively and not conjunctively. 1.26.24. From the fact that (d) "formulations manufactured from bulk drugs", are mentioned separately, it can be inferred that (a) "all drugs and medicines" intends to cover 'bulk drugs' only, while (d) covers the formulations, drugs and medicines which are manufactured from such bulk drugs. If (a) and (d) were intended to mean the same, i.e. that only drugs and medicines for final consumption are covered under the entry, then it would render (a) to be redundant, as (d) already covers such final formulations (often classified under Chapter 30). 1.26.24.Furthermore, all ready to use drugs are covered under Chapter 30 of the Customs Tariff. The fact that the Not....
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....ordingly, the term "drugs" should also cover bulk drugs/API. 1.26.30. In fact, prior to Notification No. 9/2025 (Integrated Tax Rate), the earlier Notification was Notification No. 1/2017 (Integrated Tax Rate). Sl. 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 esters and diagnostic test kits, specified in List 1 appended to this Schedule 1.26.31. During the prevalence of the above Notification, as long as the API imported was mentioned in the List 1, IGST of 5% alone was levied. With the new Notification No. 9/2015, the entry almost remains the same, and just the List has been removed. Thus, if APIs mentioned in List 1 were considered to be drugs prior to September, even post the removal of List they will continue to be treated as drugs. In fact, by removal of a restrictive list, the Notification has been expanded and liberalised. Thus, APIs too are undoubtedly drugs. API for 'testing, clinical research and bioequivalence study' also fall under ....
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....der 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;" 1.26.34. It is submitted that from a combined reading of the definitions of 'drugs', 'bioavailability study', 'bioequivalence study' and 'clinical trials', it is clear that drugs cover even those products which are for bioavailability or bioequivalence studies, or clinical trials. 1.26.35. It is submitted that the definitions of bioavailability study, bioequivalence studies and clinical trials would be rendered redundant if the definition of 'drugs' itself was construed to not cover the drugs which are intended for such purposes. 1.26.36. Thus, as long as the product in question is regarded as "Drug" by the CDSCO, irres....
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....urden 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 Court in Safari Retreats." 1.26.41. From the above it is clear that a taxing notification, which prescribes a levy and is not prescribing an exemption, is to be interpreted in favour of the taxpayer. Reliance is also placed on the decision of the Supreme Court in Commissioner of Cus. (Import), Mumbai v. Dilip Kumar & Company, 2018 (361) E.L.T. 577 (S.C.), whereby it established the principle that in case of an ambiguity in a taxing statute and where two interpretations can be adopted, then the benefit of interpretation is to be given to the assessee. It is only in the case of an exemption notification that it should be interpreted in favour of the Revenue. IGST N....
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....ugs 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 considered clause (i) and have not considered clause (iii) (refer para 18 in Sterling * Decision and para 11 in Altis decision) Furthermore, the rulings have failed to take into consideration the previous decisions and rulings on the interpretation wherein "Drugs" was time and again held to include bulk drugs. 4. In Re: M/s. Altis Finechem Pvt. Ltd. 2021 (1) TMI 564 - AAR, Guj. ADVANCE RULING NO. GUJ/GAAR/R/61/2020 Enclosed as 'Exhibit - I'. 1.26.44. The above Rulings are not pertaining to the present legal position. Thus, they are not strictly applicable to the present Application. However, in the interest of completion of information,....
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....14.08.2026 furnished its comments in respect of the instant application no. 20/2026 and 21/2026 respectively, which are reproduced as under :- 2.2.1. Eligibility of the applicant, in terms of Section 28E(c) of the Customs Act, 1962 to seek such advance ruling: Yes, M/s Mankind Pharma Limited is a valid applicant within the meaning of Section 28E(c) (i) of the Customs Act, 1962. having IEC Code 0593044312. 2.2.2. 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. 2.2.3. Specify whether the claim of the applicant regarding the nature of activity, i.e. it is ongoing/proposed is correct: As per available records and as declared by the applicant, The Applicant has been importing the Bulk Drugs/API in question under Form 10, Form 11 & Form CT-17 licence and has been discharging IGST ....
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....ariff 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) 2.2.7. 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 any Chapter'. 2.2.8. Nature of the Goods and Whether 'Bulk Drugs/APIs' Fall Drugs Within 'All Drugs and Medicines' 2.2.8.1. 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. 2.2.8.2. Section 3(b) of the Dr....
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....ition reinforces their statutory character as 'drugs', irrespective of whether they are imported for manufacture 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'. 2.2.9. 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. 2.2.9.1. Applicability to Bulk Drugs/APIs- Bulk Drugs/APTs are covered under....
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....try as such, any genuine ambiguity is to be resolved in favour of the taxpayer. This 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. 2.2.12. Judicial Precedents Holding that 'Bulk Drugs' are '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 intro....
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....ework, I find the application to be valid in terms of the Customs Act, 1962 and the CAAR Regulations, 2021. I, therefore, allow the application and proceed to determine the Levy of IGST on Bulk drugs or Active Pharmaceutical ingredients (APIs) on the basis of the information on record. The question posed for advance ruling is: Question 1: "Whether Integrated Goods and Services Tax (IGST) is leviable @ 5% on import of bulk drugs (Active Pharmaceutical Ingredients - APIs) in terms of SL. No. 226 of Schedule I to Notification No. 9/2025-Integrated Tax (Rate) dated 17.09.2025?" Question 2: "If Not then what is the correct rate of the IGST leviable for the import of bulk drugs/API falling under chapter 28 or 29 of the Schedule of Customs Tariff Act, 1975?" 4.2. Statutory Framework 4.2.1. In terms of Section 3(7) of the Customs Tariff Act, 1975, any article imported into India is liable to IGST at such rate as is leviable under Section 5 of the IGST Act, 2017 on a like article supplied in India. Section 3(7) of the Customs Tariff Act, 1975 has been reproduced below: "Any article which is imported into India shall, in addition, be liable to integrated tax ....
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....r analysis subject to prescribed conditions and only under a licence in Form 11. Therefore, the statutory scheme itself recognises the goods covered thereunder as drugs and regulates their import accordingly. The grant of a Form 11 licence is predicated upon the goods possessing the character of drugs under the Drugs and Cosmetics Act,1940 and not upon their intended end-use. Consequently, the fact that an API or bulk drug is imported for examination, testing or analysis does not alter its essential character as a drug. 4.5. I further note that Rule 23 of the Drugs and Cosmetics Rules, 1945 specifically deals with "Import licences" and prescribes the statutory requirement for obtaining an import licence for drugs. Rule 23 provides that an import licence in Form 10 shall be required for the import of drugs, other than those specified in Schedule X. Rule 68 of New Drugs and Clinical Trials Rules, 2019 deals with the Grant of licence for import of new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis. 4.6. Further, the applicant has submitted that there is no dispute regarding tariff classificatio....
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....he 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 prevention of disease; and * all substances intended for use as components of a drug. 4.10.1. I observe Active Pharmaceutical Ingredients(APIs) are substances used as component of a drug. The....
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....rmaceutical ingredient" means any substance which can be used in a pharmaceutical formulation with the intention to provide pharmacological activity; or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease; or to have direct effect in restoring, correcting or modifying physiological functions in human beings or animals; 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 verif....
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....al decisions wherein it has been held that bulk drugs are also drugs or "drugs" is inclusive of "bulk drugs". a. The Tribunal in Burroughs Wellcome (I) Ltd vs Commissioner of C. Ex. and Cus., Mumbai [2007 (216) E.L.T. 522 (Tri-Mum)],held that the phrase "life saving drugs" has not been defined either in the notification or in the Drugs (Prices Control) Order. Moreover, "drugs" have been defined to include "bulk drugs" b. The Tribunal in Cipla Ltd. v. Commissioner of Customs, Chennai - 2007 (218) E. L.T. 547 (Tri .- Chennai) held that it is beyond doubt that 'bulk drugs' are also 'drugs. c. In Astrix Laboratories Ltd. - 2009 (233) E.L.T. 372 (Tri .- Bang.), the Customs, Excise and Service Tax Appellate Tribunal (CESTAT), Bangalore Bench ruled that bulk drugs qualify as "drugs" These decisions consistently held that bulk drugs are also drugs, particularly where the exemption/benefit entry uses the expression "drugs" without exclusion. 4.13.2 Further, in Aurobindo Pharma Ltd. - 2009 (247) E.L.T. 206 (Tri .- Bang.), it was held that exemption notifications do not distinguish between bulk drugs and other drugs or medicines, meaning duty exemp....
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....egislative intent to extend the scope of coverage beyond Chapter 30, thereby encompassing drugs and drug substances classifiable under other Chapters, including Bulk drugs or Active Pharmaceutical ingredients (APIs) falling under Chapters 28 and 29. 4.15.4. In view of the above discussion as well as on conjoint reading of definition of drugs given in Section 3(b) of Drugs and Cosmetics Act, 1940, Bulk drugs or Active Pharmaceutical ingredients (APIs) as mentioned in Drugs (Price Control) Order. 2013 and reading of the definitions of "bioavailability study", "bioequivalence study" and "clinical trial" as mentioned in New Drugs and Clinical Trials Rules, 2019, it can be concluded that the bulk drugs/APIs fall within the statutory meaning of "drug". 4.15.5. I observe that SI. Nos. 35 and 36 of Schedule II cover "All inorganic chemicals" falling under Chapter 28 and "All organic chemicals" falling under Chapter 29 respectively. These entries are broad and generic in nature, as they encompass all goods classifiable under the said Chapters without any restrictive description. 4.15.6. In contrast, SI. No. 226 specifically covers " All Drugs and medicines including their salts and....
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....that the IGST Notification in question is a taxing notification and not an exemption notification. Therefore, applying the ratio laid down in Dilip Kumar & Company, the subject goods of the applicant are appropriately classifiable under SI. No. 226 of Schedule I to Notification No. 9/2025-Integrated Tax (Rate) dated 17.09.2025, which is a taxing entry and not an exemption entry. 4.17. Conclusion: 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) APIs are regulated and licensed as "drugs" by the Central Drugs Standard Control Organization (CDSCO) under the statutory framework of the Drugs and Cosmetics Act, 1940 and the New Drugs and Clinical Trials Rules, 2019, including for import under Forms 10, Form 11 and Form CT- 17. Their regulatory recognition as drugs reinforces their statutory character. iii) Judicial precedents and....