TaxTMI 
TaxTMI 
2026 (8) TMI 655
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....otification No. 9/2025- Centra! Tax (Rate) dated 17.09.2025 (hereinafter referred to as the 'IGST Rate Notification')? ii. If not, then what is the correct rate of IGST leviable for the import of bulk drugs falling under chapter 28 or 29 of the Schedule to Customs Tariff Act, 1975? 3. Submission by Applicant- 3.1 Intas Pharmaceuticals Limited is a pharmaceutical company incorporated in 31.05.1985. The Applicant is a leading manufacturer and supplier of pharmaceutical products. 3.2 Copy of certificate of incorporation of the Applicant Company is filed along with this application. 3.3. 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/analysis, clinical research and Bioequivalence study. These imported ingredients, which are active ingredients for medicines, are hereinafter collectively referred to as "bulk drugs". 3.4 Bulk drugs are classified under Chapter 28 or Chapter 2....
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....G 4.1.1 In order to file an application before the Authority for Advance Ruling, the Applicant must satisfy the conditions prescribed under the Customs Act, 1962 (hereinafter referred to as 'Customs Act'). 4.1.2 Provisions relating to Advance Ruling are prescribed under Chapter VB of the Customs Act. Clause (c) of Section 28E of the Customs Act defines an "Applicant" as: In this chapter, unless the context otherwise requires, (c) "applicant" means- (i) holding a valid Importer-exporter Code Number granted under section 7 of the Foreign Trade (Development and Regulation) Act, 1992 (22 of 1992); (Emphasis Supplied) 4.1.3 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 0896004341. 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; (Emphasis Supplied) 4.1.4 The questions o....
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....pellate Tribunal, or any Court; b. the question raised in the present application regarding the rate of IGST for import of bulk drugs is not a matter already decided by the Appellate Tribunal or any Court 4.1.7 Therefore, it flows that in the present case, the Applicant satisfies all the criteria required for filing the application for advance ruling, namely: (a) The Applicant has been granted a valid Importer-Exporter Code Number (IEC) under section 7 of the Foreign Trade (Development and Regulation) Act, 1992; (b) The Applicant is filing the Application in respect of goods prior to their importation into 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. 4.1.8 Thus, the present application must be allowed to be proceeded with. 4.2 QUESTION OF LEVY OF IGST ON THE IMPORT OF BULK DRUGS 4.2.1 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....
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....er any Chapter fall under its ambit and are subject to levy of IGST @5%. The bulk drugs in question are generally classified under Chapter 28 or 29. It is clear that these bulk drugs, 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. Condition ii: From a combined reading of the definitions of bulk drugs and drugs under various laws and literature, it is clear that the term "All Drugs and medicines" is inclusive of bulk drugs and hence, levy of IGST in terms of SI. No. 226 of Schedule I to the Notification shall apply to bulk drugs. 4.2.9 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 ....
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....gredient 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. 4.2.12 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 or proposed to be obtained for import of bulk drugs: Form No and Licence/Registration Issued 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 ....
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....r tissues function * medicine. a preparation taken to treat a disease or condition, especially one in liquid form Stedman's Medical Dictionary: * drug. I. Any substance employed as a medicine in the treatment of disease. 4.2.16A 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 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 4.2.17 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 "....
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....pted the assessees contention and held that the drugs imported by them were to be categorized under S I. 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 .& Pfizer Ltd. 5. In the instant case, admittedly, the 'bulk drugs' imported by the appellants were specifically mentioned in List 3 app....
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.... is submitted that the interpretation that bulk drugs 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 as well. 4.2:24 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 Sterlling Biotech Lid, 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.....
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....and esters of such drugs and medicines; (c) diagnostic test kits; and (d) formulations manufactured from bulk drugs. 4.2.28 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. 4.2.29 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 be read disjunctively and not conjunctively. 4.2.30 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) cove....
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....ition 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.Rs. 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)." 4.2.35 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 for 'testing/analysis, clinical research and bioequivalence study' also fall under the ambit of 'drugs' and are leviable with IGST @5% 4.2.36 The relevant definitions from the Drugs and Cosmetic Rules, 1945 are extracted below: b) "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 preparations applied on human body for the purpose of repelling insects like mosquitoes; ] (ii). such substances (other than food) intended to af....
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....rugs', 'bioavailability study', 'bioequivalence study' and 'clinical trials', it is clear that drugs covers even those products which are for bioavailability or bioequivalence studies, or clinical trials or test/analysis purpose. 4.2.39 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. 4.2.40 Thus, as long as the product in question is regarded as "Drug" by the CDSCO, irrespective of whether it is for manufacture of medicines, or for clinical trials, it must be considered to be eligible to avail benefit of SI, No. 226 of Notification No. 9/2025-Integrated Tax (Rate) dated 17.09.2025. The bulk drugs classified under Chapter 28 or Chapter 29 are still rightly subject to levy under SI. No. 226 of Schedule I, and not under SI. No. 35 or 36 of Schedule II to the IGST Rate Notification. In case of any ambiguity in the IGST Rate Notification, it should be interpreted in favour of the taxpayer 4.2.41 SI. No. 35 and 36 of Schedule II to the IGST Rate N....
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....t 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 Notification is a taxing statute and not an exemption notification. Thus, even on applying the decision of Dilip Kumar the interpretation should be in favour of the Applicant. Few Advance Rulings on this issue Customs Advance Ruling issued to CIPLA on identical issue 4.2.46 Ruling CAAR/Mum/ARC/161,162/2025-26 dated 17.03.2026 was issued to Cipla Limited, by CAAR, Mumbai (Enclosed as 'Exhibit - C'). This 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....
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....- F'. * 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 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 - G'. 4.2.49 The above Rulings are not pertaining to the present legal position. Thus, they are not strictly applicable to th....
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....2026 and 18.05.2026. However, no comments were received from the said Commissionerate's. 6. Details of Personal Hearing A personal hearing in this matter was conducted on 09.06.2026 at 4:20 pm. Representative explained a few Active Pharma Ingredient & Bulk Ingredient are drug with definition of Drug and Cosmetic Act, 1940 and how their products are eligible for 5% IGST. They also provided copy of earlier Advance Ruling issued by previous authority in similar matters. No one appeared from department. 7. Discussion and Findings 7.1 I have carefully considered the application filed by Intas Pharmaceutical limited, the written and additional submissions made by the Applicant, and the records placed before me. 7.2 At the outset, I find that the issue raised in the question in the form CAAR-1 is squarely covered under Section 28H(2) of the Customs Act, 1962, being a matter related applicability of duty (IGST rate in the present case) under the provisions of this Act. The question posed for advance ruling is :. "Whether Integrated Goods and Services Tax (IGST) is leviable @ 5% on import of bulk drugs (Active Pharmaceutical Ingredients - APIs) in terms of SI. No. 22....
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....807, issued under the Drugs and Cosmetics Rules, 1945 for import of drugs (excluding those specified in Schedule X). The Applicant has stated that imports of the subject bulk drugs have been undertaken under the said Form 10 licence. 7.4.3 The Applicant has further submitted that it also proposes to import bulk drugs for clinical testing and related purposes in future under licences such as: (a) Form 11, prescribed under Rule 33 of the Drugs and Cosmetics Rules, 1945 for import of drugs for examination, test or analysis; and (b) Form CT-17, prescribed under the New Drugs and Clinical Trials Rules, 2019 for import of a new drug or investigational new drug for clinical trials, bioavailability studies, bioequivalence studies, examination, test or analysis. 7.4.4 Thus, the material placed on record shows that the subject APIs are imported, or proposed to be imported, under the regulatory framework administered by the Central Drugs Standard Control Organisation (CDSCO) as drugs governed by the Drugs and Cosmetics Act, 1940 and the rules framed thereunder. 7.4.5 I further note that Rule 33 of the Drugs and Cosmetics Rules, 1945 specifically deals with "Import o....
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.... "Whether "Bulk Drugs/APIs" are covered under the expression "All Drugs and Medicines" or otherwise" 7.5.1 The expression "drugs" is not defined in the IGST Rate Notification and neither in Customs Act. In such circumstances, recourse can be taken to the relevant statute governing the goods, namely the Drugs and Cosmetics Act, 1940. 7.5.2 "I observe Section 3(b) of the Drugs and Cosmetics Act, 1940 defines "drug" . The said definition of drugs is produced as below: 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 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 6 [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;] 7 (iii) all....
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....nclusion is further reinforced by the regulatory licences relied upon by the Applicant. Form 10 is issued for import of drugs, Form 11 is issued for import of drugs for examination, test or analysis, and Form CT-17 is issued for import of a new drug or investigational new drug for clinical trials, bioavailability studies, bioequivalence studies, examination, test or analysis. Therefore, whether the API is imported for manufacture of formulations, examination, testing, analysis, clinical trials, bioavailability studies or bioequivalence studies, the regulatory framework consistently treats the imported goods as "drugs" 7.5.7 The applicant has submitted that Prior to 2019, the definitions of 'bioavailability study', 'bioequivalence study' and 'clinical trials' were also under the Drugs and Cosmetics Rules, 1945. However, with the introduction of the New Drugs and Clinical Trials Rules, 2019, the definitions were omitted from the Drugs and Cosmetics Rules 1945. The relevant definitions from the New Drugs and Clinical Trials Rules, 2019 are extracted below: "2. Definitions. - (1) In these rules, unless the context otherwise requires, *** ....
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....indo Pharma Ltd. - 2009 (247) E.L.T. 206 (Tri .- Bang.), it was held that where a notification does not distinguish between "drugs" and "bulk drugs", such distinction cannot be artificially introduced. 7.6.3 Advance ruling decisions: i) I further note that this Authority, in the case of M/s Cipla Ltd., while examining the applicability of SI. No. 226 of Notification No. 09/2025-Integrated Tax (Rate) dated 17.09.2025 to imports of Bulk Drugs/Active Pharmaceutical Ingredients (APIs), held that APIs/Bulk Drugs are covered within the expression "All Drugs and medicines" appearing in the said entry. The Authority, after examining the definition of "drug" under Section 3(b) of the Drugs and Cosmetics Act, 1940, the definition of "bulk drug" under the Drugs (Price Control) Order, 2013, and the relevant judicial precedents, concluded that Bulk Drugs/APIs are drugs for the purposes of the said notification and are therefore eligible for levy of IGST at the concessional rate of 5%. ii) I observe that in Laurus Labs Ltd., 2018 (13) G.S.T.L. 472 (A.A.R. - GST) and Biocon Ltd., 2020 (43) G.S.T.L. 281 (App. A.A.R. - GST - Kar.), the Advance Ruling Authorities have taken the ....
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....ug" and are drugs only. 7.8 Whether APIs imported for Clinical Trials / Bioequivalence Studies are excluded: 7.8.1 A question arises as to whether Active Pharmaceutical Ingredients (APIs) imported for use in clinical trials, bioavailability studies or bioequivalence studies can be regarded as falling outside the scope of SI. No. 226 of Schedule I of Notification No. 09/2025-Integrated Tax (Rate) dated 17.09.2025 merely because such imports are not intended for immediate therapeutic administration. 7.8.2 The issue is required to be examined in the light of the statutory provisions of the Drugs and Cosmetics Act, 1940 and the New Drugs and Clinical Trials Rules, 2019. i) Section 3(b) of the Drugs and Cosmetics Act, 1940 defines "drug" to include substances intended for diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and also includes components of a drug. ii) Clinical trials, bioavailability studies and bioequivalence studies are statutorily regulated under the New Drugs and Clinical Trials Rules, 2019, which form part of the legal framework governing the development, evaluation and approval of drugs intende....
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....ination, test or analysis are excluded: 7.9.1 I further observe that certain APIs/Bulk Drugs may be imported under Form 11, being a licence issued under the Drugs and Cosmetics Rules, 1945 for import of drugs for the purposes of examination, test or analysis. A possible view may be that goods imported under Form 11 are not intended for immediate therapeutic use and therefore fall outside the scope of SI. No. 226. 7.9.2. The above view is not acceptable for the following reasons: (i) Rule 33 of the Drugs and Cosmetics Rules, 1945 specifically permits import of drugs for the purposes of examination, test or analysis under a licence in Form 11. Thus, the statutory framework itself recognises that the goods imported under Form 11 are drugs. (ii) Neither the Drugs and Cosmetics Act, 1940 nor Notification No. 09/2025-Integrated Tax (Rate) prescribes that a product must be intended for immediate therapeutic administration at the time of import in order to qualify as a drug. (iii) Examination, testing and analysis are recognised regulatory activities undertaken for quality assessment, research, product development, validation, stability studies, regulatory ....
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....other than gibberellic acid" 7.10 Nature of the Notification 7.10.1 I observe Notification No. 9/2025-Integrated Tax (Rate) is a rate notification and not an exemption notification. 7.10.2. I observe that the applicant has placed reliance on the decision of the Hon'ble. Supreme Court in Commissioner of Customs (Import), Mumbai v. Dilip Kumar & Company, 2018 (361) E.L.T. 577 (S.C.), wherein it was held that in case of ambiguity in a taxing statute, and where two interpretations are possible, the interpretation beneficial to the assessee should be adopted. However, in the case of an exemption notification, the same must be construed strictly in favour of the Revenue. I observe 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. i) The definition of "drug" under Section 3(b) of the Drugs and Cosmetics Act. 1940 is wide and inclusi....
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....e 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 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 recogniti....