Statutory exemption under drug import rules barred a Form 10 licence and unsupported re-export directions.

Where imported goods fell within the statutory exemption under Rule 43 read with Schedule D of the Drugs and Cosmetics Rules, 1945, the Form 10 licence requirement could not be imposed by executive direction. The court held that the goods could not be treated as drugs for human use contrary to the governing rules, and that any settlement or conditions recorded in proceedings before another High Court could not displace the applicable statutory framework. The directions for re-export and related restrictions were therefore unsustainable. Release of the goods was permitted subject to verification of compliance with the prescribed rule and label requirements, while valuation issues were left open for adjudication before the appropriate forum.

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Issues: Whether the imported goods, described as not meant for pharmaceutical or drug use, could be subjected to the Form 10 licence requirement and treated as drugs for human use, and whether the consequential orders directing re-export and related restrictions could be sustained.

Analysis: The writ appeals arose from orders directing the importers to obtain a Form 10 licence and permitting the authorities to treat the goods as drugs for human use. The Court held that the importers had complied with Rule 43 read with Schedule D of the Drugs and Cosmetics Rules, 1945, and that the statutory exemption could not be displaced by executive action. It also held that a settlement or conditions recorded in proceedings before another High Court could not override the statutory framework applicable to the present imports. The impugned directions were therefore unsustainable.

Conclusion: The requirement of a Form 10 licence was held inapplicable on the facts, and the orders treating the goods as drugs for human use were set aside.

Final Conclusion: The importers were entitled to release of the goods on verification of compliance with the prescribed rule and label requirements, while valuation issues were left open for adjudication before the appropriate forum.

Ratio Decidendi: Where an importer satisfies the conditions of a statutory exemption under the governing rules, the administration cannot impose a contrary licensing requirement or other restriction by executive direction.

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