Cosmetics import restrictions under drug rules apply outside limited Schedule D exemptions for specified imports.

Cosmetics imported into India do not fall within the Schedule D exemption for "substances not intended for medicinal use" merely because they are not drugs. The Drugs and Cosmetics Act and Rules treat cosmetics separately from drugs, and a cosmetic is not a "substance" for claiming the general exemption in Schedule D. Rule 133 therefore applies import restrictions to cosmetics, while Rule 132 does not exempt them generally; only the specific Schedule D category, including cosmetics imported for manufacture and export by SEZ units, is exempt. Imported cosmetics outside that limited category must enter through the notified points under Rule 43-A, and non-compliant imports are liable to confiscation.

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Issues: (i) Whether cosmetics imported into India fall within the exemption for "substances not intended for medicinal use" in Schedule D of the Drugs and Cosmetics Rules, 1945 so as to avoid the restriction under Rule 133 read with Rule 43-A of the Drugs and Cosmetics Rules, 1945.

Analysis: "Cosmetic" and "drug" are separately defined under the Drugs and Cosmetics Act, 1940. A cosmetic, being an article intended for application to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance, cannot be treated as a "substance" within the meaning of the drug definition so as to claim the general exemption in Schedule D. Rule 133 makes the import restriction applicable to cosmetics, and Rule 132 does not exempt cosmetics generally; the exemption in Schedule D is confined to cosmetics covered by the specified category, including those imported for manufacture and export by SEZ units. The imported goods, being cosmetics and not falling within that special exemption, were subject to the notified points of entry under Rule 43-A.

Conclusion: The restriction under Rule 133 read with Rule 43-A applied to the imported cosmetics, and the goods were liable to confiscation for having been imported contrary to law.

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