2026-VIL-13-AAR-CU
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  2. 2026-VIL-13-AAR-CU

CUSTOMS Advance Ruling Authority

Customs AAR – Scope of expression "consumables" – Import of Reference Listed Drugs (RLDs), Active Pharmaceutical Ingredients (APIs), impurities, chemicals, reagents, enzyme powders, pre-filled syringes, packaging materials, vials, canisters and similar items - Applicability of Notification No. 45/2025-Customs dated 24.10.2025 to various goods proposed to be imported for use in research and development activities undertaken at DSIR-recognized facilities - Whether goods imported and utilized during the research and development stage prior to manufacture of the Exhibit Batch (also referred to as confidence building batch or scale-up batch) are eligible for the benefit of Notification No. 45/2025-Customs - HELD – Firstly, the applicant's DSIR-recognized Research and Development Centres situated at Pune and Aurangabad satisfy the institutional eligibility requirement prescribed under Notification No. 45/2025-Customs dated 24.10.2025 and qualify as eligible research institutions for the purposes of the said notification – The goods which are wholly or substantially consumed, exhausted or expended during the course of research, testing, experimentation or development activities may appropriately be regarded as consumables. The goods such as Reference Listed Drugs (RLDs), Active Pharmaceutical Ingredients (APIs), impurities, chemicals, reagents, enzyme powders and other similar materials which are consumed or substantially utilized in research, testing, analytical evaluation, formulation development, validation and stability studies, would generally fall within the scope of the term "consumables" for the purposes of Notification No. 45/2025-Customs – The subject goods, which are consumed or substantially utilized in formulation development, analytical evaluation, testing, validation, stability studies and other research activities undertaken by the applicant's DSIR-recognized R&D Centres, are covered within the scope of the expression "consumables" under Sl. No. 70 of Notification No. 45/2025-Customs and are eligible for the benefit of notification, subject to fulfilment of the conditions prescribed therein – Ordered accordingly - Whether goods imported for manufacture of the Exhibit Batch are eligible for the benefit of the notification – HELD – The benefit of Notification No. 45/2025-Customs is available only in respect of imports made by the eligible DSIR-recognized research institution for its research activities. The goods imported by the DSIR-recognized R&D Centres and thereafter transferred, supplied or moved to a manufacturing facility for manufacture of an Exhibit Batch are not eligible for the benefit of Notification No. 45/2025-Customs, as such transfer is contrary to Condition No. 24(A)(2), which prohibits transfer or sale of the imported goods for a period of five years from the date of importation – Further, the goods imported directly by a manufacturing facility for manufacture of an Exhibit Batch are not eligible for the benefit of Notification No. 45/2025-Customs, since the importing entity is not a DSIR-recognized research institution as required under the notification.
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