Classification of diagnostic contrast medium denied as pharmaceutical chemical; exemption also failed because tariff heading requirements were not met.

Amidotrizoic Acid USP was held not to satisfy classification as a pharmaceutical chemical under Heading 29.01/45(13) because its pharmacopoeial use was as a contrast medium in diagnostic radiology, including urography and angiography, which is a diagnostic aid rather than a prophylactic or therapeutic drug. The Assistant Drug Controller's endorsement did not establish the required therapeutic value or predominant drug use. The broader scope of Notification No. 234/82-C.E. for bulk drugs did not control Customs tariff classification, since its explanation covered diagnostic chemicals meeting pharmacopoeial standards. As exemption under Notification No. 33/83 depended on the tariff classification being satisfied, the claimed exemption was also unavailable.

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Issues: Whether Amidotrizoic Acid USP was classifiable as a pharmaceutical chemical under Heading 29.01/45(13) of the Customs Tariff Act, 1975 and, if so, whether it was eligible for exemption under Notification No. 33/83.

Analysis: For classification under Heading 29.01/45(13), the goods had to be pharmaceutical chemicals having prophylactic or therapeutic value and used solely or predominantly as drugs. The imported material, though conforming to USP standards, was shown by the pharmacopoeial literature to be used as a contrast medium in diagnostic radiology and for procedures such as urography and angiography. That use amounted to a diagnostic aid rather than a curative or preventive medicine. The endorsement of the Assistant Drug Controller did not establish the necessary prophylactic or therapeutic value. The benefit of Notification No. 234/82-C.E. for bulk drugs did not govern classification under the Customs Tariff, because that notification covered a wider description and its Explanation embraced diagnostic chemicals conforming to pharmacopoeial standards. The claimed exemption under Notification No. 33/83 depended on satisfaction of the tariff heading itself.

Conclusion: The goods were not classifiable under Heading 29.01/45(13) and were not entitled to exemption under Notification No. 33/83.

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