Import licence requirement for non-medicinal substance held inapplicable where declared end use was non-pharma and undertaking protected compliance.

Imported Inositol NF 12 declared as not intended for medicinal use was treated as falling within the exemption scheme for substances outside medicinal manufacture. Because the disclosed end use was non-pharma, including food, nutraceutical and beverage applications, the insistence on a Form 10 or Form 10-A licence was held inapplicable. The authorities' licensing objection was further weakened by the absence of any dispute on the declared purpose of import. Release of the goods was permitted on the importer's undertaking to restrict sales to non-pharma users and to provide end-user details and transactional reconciliation, which was considered sufficient to protect regulatory compliance.

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Issues: Whether imported Inositol NF 12, declared as not intended for medicinal use, could be detained for want of Form 10 or Form 10-A licence and whether the goods were liable to be released on an undertaking that they would be used only for non-pharma purposes.

Analysis: The import was for a substance expressly described as not for medicinal use, and the materials showed that it was purchased for non-pharma industries such as food, nutraceutical and beverage use. On that footing, the exemption scheme under the Drugs and Cosmetics Rules governing substances not intended for medicinal use was held applicable. The licensing requirement under the import-licence provision was treated as inapplicable where the disclosed purpose of import was outside medicinal manufacture, especially since the respondents did not dispute the declared end use. The petitioner also gave an undertaking to confine sales to non-pharma users and to furnish end-user particulars and transactional reconciliation, which adequately protected the regulatory interest.

Conclusion: The insistence on Form 10 or Form 10-A was held unsustainable and the authorities were directed to release the goods after obtaining the necessary undertaking.

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