Strict customs exemption for DSIR-registered research institutions covers research-stage consumables, but not Exhibit Batch manufacturing imports.

Notification No. 45/2025-Customs applies strictly to DSIR-registered research institutions. The applicant's R&D centres were treated as eligible research institutions because the recognition and registration documents were produced and no suspension or withdrawal was shown. Research-stage consumables imported and substantially used in formulation development, testing, validation and stability studies also qualify, subject to the prescribed conditions. By contrast, goods imported for manufacture of the Exhibit Batch do not qualify because the exemption is institution-specific, goods cannot be transferred or sold contrary to the five-year condition, and a manufacturing facility that is not the eligible research institution cannot claim the benefit.

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Issues: (i) whether the applicant's DSIR-recognized R&D centres qualify as eligible research institutions for the purposes of Notification No. 45/2025-Customs; (ii) whether goods imported and consumed or substantially utilized during the research and development stage prior to manufacture of the Exhibit Batch are eligible for the benefit of the notification; and (iii) whether goods imported for manufacture of the Exhibit Batch are eligible for the benefit of the notification.

Issue (i): whether the applicant's DSIR-recognized R&D centres qualify as eligible research institutions for the purposes of Notification No. 45/2025-Customs.

Analysis: The notification requires the importer to be a research institution registered with the Department of Scientific and Industrial Research. The applicant produced recognition and registration materials for its Pune and Aurangabad centres, and no material showed suspension or withdrawal of such recognition.

Conclusion: The applicant's DSIR-recognized R&D centres qualify as eligible research institutions under the notification.

Issue (ii): whether goods imported and consumed or substantially utilized during the research and development stage prior to manufacture of the Exhibit Batch are eligible for the benefit of the notification.

Analysis: Entry 70 covers consumables, and the expression is not separately defined in the notification. Goods such as reference listed drugs, active pharmaceutical ingredients, impurities, chemicals, reagents, enzyme powders and similar materials, when consumed or substantially used in formulation development, analytical evaluation, testing, validation and stability studies, fall within that expression, subject to compliance with the prescribed conditions.

Conclusion: Such goods are eligible for the benefit of the notification, subject to fulfilment of the conditions prescribed therein.

Issue (iii): whether goods imported for manufacture of the Exhibit Batch are eligible for the benefit of the notification.

Analysis: The exemption is institution-specific and conditional. Goods transferred from the DSIR-recognized research institution to a manufacturing facility violate the prohibition on transfer or sale for five years. Goods imported directly by the manufacturing facility also fail because the importer is not the eligible research institution contemplated by the notification.

Conclusion: Goods imported for manufacture of the Exhibit Batch are not eligible for the benefit of the notification.

Final Conclusion: The ruling recognizes eligibility of the applicant's DSIR-recognized research centres and covers consumable research-stage imports, but excludes Exhibit Batch imports from the concessional regime because the notification must be satisfied strictly and its institutional and non-transfer conditions cannot be enlarged by implication.

Ratio Decidendi: An exemption notification granting customs benefit to specified research institutions must be applied strictly, and only goods imported by the eligible institution for approved research use and in compliance with all substantive conditions can qualify; goods transferred to another facility or imported by a non-eligible importer do not.

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