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API classification under the drugs-and-medicines entry determines concessional IGST treatment, subject to any applicable nil-rate exclusion.
Bulk drugs and active pharmaceutical ingredients (APIs) classified under Chapters 28 or 29 qualify as "all drugs and medicines" under Serial No. 226 of Schedule I to Notification No. 9/2025-Integrated Tax (Rate), including where imported for manufacture, testing, clinical trials, bioavailability, or bioequivalence studies. The term "drugs" includes substances intended as drug components, and the entry's reference to goods under Chapter 30 "or any Chapter" extends to APIs outside Chapter 30. The specific drugs-and-medicines entry prevails over general chemical entries. Such imports attract 5% IGST, unless the particular API is covered by the nil-rate exclusion under Serial No. 113 of Notification No. 10/2025-Integrated Tax (Rate).
Bulk drugs/active pharmaceutical ingredients as drugs and medicines for IGST rate - Specific description-based IGST entry prevailing over general Chapter-based entries - Generalia specialibus non derogant Bulk drugs/active pharmaceutical ingredients as drugs and medicines - IGST rate on imported bulk drugs - Eligibility of imported bulk drugs/active pharmaceutical ingredients, including those used in pharmaceutical formulations, testing, clinical research, bioavailability or bioequivalence studies, for the IGST rate applicable to "All Drugs and medicines" - HELD THAT: - The rate notification did not define "drugs". On a conjoint reading of the statutory definition of drug, which includes substances intended for use as components of a drug, and the definition of active pharmaceutical ingredients or bulk drugs, the Authority held that APIs fall within the meaning of drugs. Their import for testing, research, clinical trials, bioavailability or bioequivalence studies did not, by itself, alter that character. The semi-colon in the entry created distinct categories, and the expression "Chapter 30 or any Chapter" showed that coverage was not confined to finished formulations under Chapter 30. The applicability of the nil-rate exclusion was to be examined for the particular goods at import. [Paras 7] Bulk drugs/APIs described in the application qualify as "All Drugs and medicines" and attract IGST at 5%, provided that the particular goods are not covered by the specified nil-rate exclusion. Specific description-based IGST entry prevailing over general Chapter-based entries - Applicability of the specific entry for "All Drugs and medicines" to bulk drugs/APIs classifiable under Chapters 28 or 29, instead of the general entries for inorganic or organic chemicals - HELD THAT: - The applicable IGST rate was governed by the specific description of the goods and not merely by their chemical tariff classification. The entries for goods under Chapters 28 and 29 were general Chapter-based entries, whereas the entry for drugs and medicines was a specific description-based entry extending to goods under any Chapter. 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 covered under SI. No. 226 for the purpose of determination of applicable IGST rate. The SI. No. 226 entry is a specific entry which will prevail over the general entry of "all organic chemicals other than gibberellic acid". Applying the ratio laid down in Court in Dilip Kumar & Company, [2018 (7) TMI 1826 - SUPREME COURT (LB)] the subject goods of the applicant are appropriately classifiable under SI. No. 226 of Schedule I to Notification No. 09/2025- Integrated Tax (Rate) dated 17.09.2025, which is a IGST taxing entry and not an exemption entry. [Paras 7] The specific entry for drugs and medicines applies in preference to the general entries for inorganic or organic chemicals, subject to the prescribed exclusions. Final Conclusion: The applications were answered in the affirmative. The subject Bulk Drugs/Active Pharmaceutical Ingredients (APIs), as described in the application and supported by the documents submitted by the Applicant, qualify as "All Drugs and medicines" under SI. No. 226 of Schedule I to Notification No. 9/2025-Integrated Tax (Rate) dated 17.09.2025 and are eligible for the concessional IGST rate of 5%, provided that the particular Bulk Drug/API is not covered under the exclusion specified in the said entry, including the goods specified at SI. No. 113 of Notification No. 10/2025-Integrated Tax (Rate) dated 17.09.2025.