Statutory exemption for Schedule D drug imports prevailed over executive circular, leaving licensing unnecessary if conditions were met.

Drugs covered by Schedule D and imported for non-medicinal use remained exempt from the import licence requirement in Form 10 or Form 10A when the conditions in Rule 43 and Schedule D were satisfied, including certification of non-medical use and proper labelling. The statutory exemption under the Drugs and Cosmetics Rules, 1945 prevailed over an executive circular issued by the Drugs Controller General, which could not curtail or override the delegated legislation. The authorities, however, retained power to act under the Act if the declared non-medicinal purpose was misused or violated.

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Issues: Whether an importer of a drug covered by Schedule D of the Drugs and Cosmetics Rules, 1945 and imported for non-medicinal use was required to obtain import licence in Form 10 or Form 10A, and whether an executive circular could override the statutory exemption under Rule 43.

Analysis: The drug in question fell within the statutory definition of "drug" under the Drugs and Cosmetics Act, 1940, but the governing scheme of Chapter III permitted exemption by delegated legislation. Rule 43 of the Drugs and Cosmetics Rules, 1945 exempted drugs specified in Schedule D from the provisions of Chapter III to the extent and subject to the conditions stated in that Schedule. Schedule D covered substances not intended for medical use and required certification of non-medical use and appropriate labelling. Once those conditions were satisfied, the statutory exemption operated and the requirement of Form 10 or Form 10A did not arise. The circular issued by the Drugs Controller General, though motivated by public interest and post-import control concerns, could not curtail or supersede the statutory rule. The authorities retained power to proceed under the Act if the importer violated the declared non-medicinal purpose.

Conclusion: The import was exempt from the requirement of Form 10 or Form 10A so long as the conditions of Rule 43 and Schedule D were complied with, and the circular could not override that statutory exemption.

Final Conclusion: The appeal failed and the writ petitioner's exemption-based claim was upheld, while the authorities were left free to take action upon proof of any misuse of the imported substance.

Ratio Decidendi: An executive circular cannot take away a statutory exemption granted by valid rules made under the parent Act, and a conditionally exempt import remains outside the licensing requirement so long as the prescribed conditions are complied with.

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