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Issues: Whether bulk drugs/Active Pharmaceutical Ingredients imported for manufacture of formulations, testing, examination, analysis, clinical research, clinical trials, bioavailability studies or bioequivalence studies qualify as drugs under Serial No. 226 of Schedule I to Notification No. 9/2025-Integrated Tax (Rate) dated 17.09.2025 and attract IGST at 5%.
Analysis: IGST on imports is governed by Section 3(7) of the Customs Tariff Act, 1975, while Serial No. 226 covers all drugs and medicines under Chapter 30 or any Chapter. The inclusive definition of drug in Section 3(b) of the Drugs and Cosmetics Act, 1940 includes substances intended for use as components of a drug. Read with the definition of bulk drug/API under the Drugs (Price Control) Order, 2013, APIs are drugs because they are pharmaceutical substances used as such or as ingredients in formulations.
Analysis: Regulatory licences for import under Forms 10, 11 and CT-17 treat the APIs as drugs. Their intended use for examination, testing, analysis, clinical trials, bioavailability studies or bioequivalence studies does not change their essential statutory character. The description-based entry in Serial No. 226 applies to drugs falling under any Chapter and, being specific to drugs, prevails over the general entries for inorganic and organic chemicals under Chapters 28 and 29. The entry is a rate notification and not an exemption notification.
Conclusion: Bulk drugs/APIs, including those imported for manufacture, testing, analysis, clinical research, clinical trials, bioavailability studies or bioequivalence studies, qualify as drugs under Serial No. 226 of Schedule I and are chargeable to IGST at 5%, provided they are not covered by the nil-rated Serial No. 113 entry.
Bulk drugs and APIs retain drug status for import and research uses, attracting the specified concessional IGST rate.
Bulk drugs and active pharmaceutical ingredients (APIs) imported for formulation manufacture, testing, analysis, clinical research, clinical trials, bioavailability studies or bioequivalence studies qualify as drugs under Serial No. 226 of Schedule I to the IGST rate notification. The inclusive definition of "drug" covers substances intended for use as drug components, and the bulk-drug definition confirms that APIs are pharmaceutical substances used directly or as formulation ingredients. Import licences also treat APIs as drugs. Their intended research or testing use does not alter that character. The specific description-based entry for drugs applies regardless of chapter classification and prevails over general chemical entries. Imports attract 5% IGST unless covered by the nil-rated Serial No. 113 entry.
IGST rate on Active Pharmaceutical Ingredients - Specific entry for drugs prevailing over general chemical entries - Meaning of drugs and medicines Whether bulk drugs/Active Pharmaceutical Ingredients imported for manufacture of formulations, testing, examination, analysis, clinical research, clinical trials, bioavailability studies or bioequivalence studies qualify as drugs under Serial No. 226 of Schedule I to Notification No. 9/2025-Integrated Tax (Rate) dated 17.09.2025 and attract IGST at 5%? - HELD THAT: - The expression "drugs" being undefined in the rate notification, its meaning was determined with reference to the statutory framework governing drugs. APIs, being substances used as components of drugs and regulated as drugs under the Drugs and Cosmetics Act, 1940, fall within the inclusive statutory meaning of that expression. The definitions of bulk drug, clinical trial, bioavailability study and bioequivalence study, together with the licensing framework for imports for manufacture, testing and clinical purposes, establish that the intended use at import does not alter the essential statutory character of APIs as drugs. Serial No. 226 is description-based, applies to goods under Chapter 30 or any Chapter, and its separate reference to formulations manufactured from bulk drugs cannot restrict "All Drugs and medicines" to finished dosage forms. As a specific entry for drugs, it prevails over the general entries for inorganic and organic chemicals under Chapters 28 and 29. If the phrase "All drugs and medicines" were to be construed as being confined solely to finished dosage forms ready for retail consumption, the subsequent and specific reference to "formulations manufactured from bulk drugs" would be rendered redundant and superfluous. It is a settled canon of statutory interpretation that an entry must be construed in a manner that gives meaning and effect to every word used therein and avoids any interpretation that would render a part of the provision otiose. The entry applies to goods falling under "Chapter 30 or any Chapter." The deliberate use of the expression "or any Chapter" manifests a clear legislative intent to extend the scope of coverage beyond Chapter 30, thereby encompassing drugs and drug substances classifiable under other Chapters, including Active Pharmaceutical Ingredients (APIs) falling under Chapters 28 and 29. In view of the above discussion as well as on conjoint reading of definition of API 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 read with Section 3(b) of the Drugs and Cosmetics Act that defines drugs, it can be safely concluded that the bulk drugs/APIs falls within the statutory meaning of "drug" and are drugs only. Whether APIs imported for Clinical Trials / Bioequivalence Studies are excluded? - Once a product is recognised as a drug or pharmaceutical substance under the applicable provisions of the Drugs and Cosmetics Act, 1940 and the rules framed thereunder, its character for classification and rate purposes cannot be determined solely on the basis of the immediate purpose for which it is imported. The fact that an API is imported for clinical evaluation, testing or regulatory studies does not detract from its identity as a pharmaceutical ingredient used in the manufacture, development or evaluation of drugs. Accordingly, find no basis to conclude that APIs imported for clinical trials, bioavailability studies or bioequivalence studies stand excluded from the scope of SI. No. 226 of Schedule I of Notification No. 09/2025-Integrated Tax (Rate) dated 17.09.2025 solely on account of such intended use. The applicability of the entry is required to be determined on the basis of the nature and identity of the goods as pharmaceutical ingredients and the relevant statutory provisions governing such products. Whether APIs imported under Form 11 for examination, test or analysis are excluded? - APIs/Bulk Drugs imported under Form 11 for examination, test or analysis continue to retain their character as drugs under the Drugs and Cosmetics Act, 1940. The intended use for examination, test or analysis does not detract from their identity as drugs and consequently does not exclude them from the scope of SI. No. 226 of Notification No. 09/2025- Integrated Tax (Rate). Specific Entry vis-à-vis General Entry - It is a well-settled principle of classification that when a product is covered by both a general entry and a specific entry; the specific entry shall prevail over the general entry (generalia specialibus non derogant). Accordingly, Active Pharmaceutical Ingredients (APIs), though classifiable under Chapters 28 or 29 for tariff purposes, when they satisfy the description of "drugs", are appropriately classifiable 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" Ruling:- Bulk drugs/Active Pharmaceutical Ingredients (APIs), whether imported for manufacture of formulations or for testing, examination, analysis, clinical research, 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). Final Conclusion: The application was answered in favour of the applicant. APIs or bulk drugs covered by the ruling are liable to IGST at 5% under Serial No. 226 of Schedule I, subject to their not falling under the specified NIL-rated entry.