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Broad drug entry covers active pharmaceutical ingredients for clinical studies and formulations, attracting reduced IGST treatment.
The rate entry for "all drugs and medicines" under Sl. No. 226 of Schedule I to Notification No. 9/2025-Integrated Tax (Rate) was construed broadly by reference to the Drugs and Cosmetics Act, 1940 and related drug-control rules. Bulk drugs and active pharmaceutical ingredients, including imports for manufacture of formulations, testing, clinical trials, bioavailability or bioequivalence studies, were treated as drugs because the statutory framework includes substances used as components of a drug. The specific drug entry was held to prevail over the general chemical entries in Chapters 28 and 29, so these imports attract IGST at 5%, subject to the nil-rate entry not applying.
Determination of IGST payable on the import of bulk drugs - Definition of "drug" under Section 3(b) of the Drugs and Cosmetics Act, 1940 - benefit of Notification no. 09/2025 -Integrated Tax-IGST (Rate) - Whether Integrated Goods and Services Tax ("IGST") is leviable @5% for the import of "bulk drugs" in terms of SI. No. 226 of Schedule I of Notification No. 9/2025-Central Tax (Rate) dated 17.09.2025 under the Customs Tariff Act, 1975. Specific Entry vis-à-vis General Entry - HELD THAT:- 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" APIs / bulk drugs are "drugs" for the purposes of SI. No. 226 and thus fall within the expression "All Drugs and medicines". 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. 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. 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. Judicial precedents and advance ruling authorities have consistently held that, in the absence of any restrictive language, the expression "drugs" includes "bulk drugs", and no artificial distinction can be introduced between the two where the notification does not provide so. The wording of SI. No. 226 of Schedule I to Notification No. 9/2025-Integrated Tax (Rate) is broad and description-based, covering "All drugs and medicines ... " without restriction to finished formulations, and further extends to goods falling under "Chapter 30 or any Chapter", thereby encompassing APIs classifiable under Chapters 28 and 29. Sl. No. 226 is a specific entry describing goods by their essential character as "drugs", and therefore prevails over the general entries covering "all inorganic chemicals" or "all organic chemicals" under Chapters 28 and 29. The character of APIs as "drugs" does not change merely because they are imported for clinical trials, bioavailability or bioequivalence studies. Such studies are integral to the drug approval process and do not alter the intrinsic statutory identity of the goods. Final Conclusion: The Authority ruled that bulk drugs / Active Pharmaceutical Ingredients (APIs) - including those imported for manufacture or for clinical trials, bioavailability or bioequivalence studies - fall within SI. No. 226 of Schedule I to Notification No. 9/2025 and attract IGST at 5%, unless they are covered by the NIL rated entry at SI. No. 113 of Notification No. 10/2025.