Notified medical devices and scope of show cause notice determine whether import restrictions and confiscation can be sustained.

Imported dental care goods were examined under the Drugs and Cosmetics regime, but only devices specifically notified by the Central Government in the Official Gazette fall within the definition of drugs under Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940. Dental cement was not shown to be a notified medical device, so Rule 43A could not be used to deny import. The commentary also notes that adjudication cannot travel beyond the show cause notice: where notice was confined to dental cement and homeopathic medicines, confiscation of all items and penalty under the Customs Act could not be sustained on a new medical-device basis.

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Issues: (i) whether the imported dental care goods could be treated as drugs or medical devices so as to attract the import restriction under the Drugs and Cosmetics regime; (ii) whether the adjudicating authority could sustain confiscation of all the imported items and penalty when the show cause notice was confined to dental cement and homeopathic medicines.

Issue (i): whether the imported dental care goods could be treated as drugs or medical devices so as to attract the import restriction under the Drugs and Cosmetics regime.

Analysis: Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940 does not treat all medical devices as drugs; only those devices specifically notified by the Central Government in the Official Gazette are covered. The imported item classified under Heading 30064000 was dental cement, and it was not shown to fall within the notified categories of devices. Rule 43A of the Drugs and Cosmetics Rules, 1945 could not therefore be invoked to deny import at ICD Dadri.

Conclusion: The goods could not be treated as prohibited drugs or notified medical devices for the purpose of Rule 43A, and the restriction on import was not attracted.

Issue (ii): whether the adjudicating authority could sustain confiscation of all the imported items and penalty when the show cause notice was confined to dental cement and homeopathic medicines.

Analysis: The show cause notice proceeded only on the allegation that the goods were homeopathic medicines, and it concerned only the dental cement item. The adjudicating authority, however, shifted the basis to medical devices and ordered confiscation of all items. An adjudication cannot travel beyond the show cause notice, and confiscation under Section 111(d) of the Customs Act, 1962 and penalty under Section 112(a)(iv) of the Customs Act, 1962 could not be sustained on a ground not put to notice, particularly when the remaining items were neither drugs nor notified medical devices.

Conclusion: The confiscation and penalty were unsustainable, including as to the items not covered by the notice.

Final Conclusion: The impugned order was set aside and the appeal was allowed, granting relief to the importer.

Ratio Decidendi: A product can be treated as a drug under Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940 only if it is a device specifically notified by the Central Government, and confiscation cannot be sustained on a ground not set out in the show cause notice.

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