Import licensing under Drugs and Cosmetics Rules depends on disclosed use; non-medicinal imports for supplements may be exempt.

The import licensing requirement under the Drugs and Cosmetics Rules, 1945 turns on the declared purpose of import. Where a substance capable of multiple uses is imported for non-medicinal use, such as manufacture of a dietary supplement, the exemption provisions in Rule 43 read with Schedule D and Rule 123 read with Schedule K prevail, and insistence on Form 10A is not warranted. The text also indicates that earlier correspondence and labeling conditions supported clearance of the consignments, and that detention was not justified where the import fell within the exempted category.

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Issues: Whether the import of Benfotiamine for manufacture of dietary supplement, and not for medicinal use, required an import licence in Form 10A or was exempt under the Drugs and Cosmetics Rules, 1945.

Analysis: Rule 23 governs import licensing, while Rule 43 read with Schedule D and Rule 123 read with Schedule K provide exemptions depending upon the purpose for which the substance is imported. The relevant consideration is the declared and disclosed use of the imported item. Where the imported substance is not intended for use in the manufacture of a drug and is instead imported for non-medicinal use, the exemption provisions apply, and the insistence on Form 10A is not warranted. The material on record showed that the import was for use in the manufacture of food supplement, and the respondents had themselves indicated in earlier correspondence that such consignments could be cleared with appropriate labeling. The availability of a show cause notice or alternative proceedings did not justify detention when the import fell within the exempted category.

Conclusion: The import was held to be exempt from the requirement of Form 10A licence, and the respondents were not entitled to insist on such licence for clearance of the consignment.

Ratio Decidendi: For goods capable of multiple uses, the applicability of the Drugs and Cosmetics Rules depends on the disclosed purpose of import; where the import is for non-medicinal use, the exemption provisions prevail over the general import-licensing requirement.

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