Pharmacopoeial standards for bulk drug exemption supported by laboratory reports, end-use certificates and purity certification.

Morphazinamide Hydrochloride imported for manufacture of a life-saving drug was treated as a bulk drug eligible for exemption under Notification No. 234/82-C.E. because the record supported conformity with pharmacopoeial standards. Although the substance was not listed in an official pharmacopoeia, certified laboratory reports described it as standard quality, the end-use certificates confirmed its use in drug manufacture, and the Food and Drugs Administration certificate described it as highly pure. Its inclusion in the Schedule to the Drugs (Prices Control) Order, 1979 further supported the conclusion that the required standard was satisfied.

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Issues: Whether Morphazinamide Hydrochloride imported by the appellants satisfied the requirement of conforming to pharmacopoeial standards so as to qualify as a bulk drug entitled to exemption under Notification No. 234/82-C.E. dated 1-11-1982.

Analysis: The notification exempted bulk drugs, medicines and drug intermediates not elsewhere specified, and defined bulk drugs as chemicals or biological or plant products conforming to pharmacopoeial standards and used for diagnosis, treatment, mitigation or prevention of disease. Although the imported substance did not appear in an official pharmacopoeia, the record showed certified laboratory reports describing the samples as standard quality, end-use certificates showing use in manufacture of a life-saving drug, and a certificate from the Food and Drugs Administration describing the goods as highly pure. The fact that the substance was shown in the Schedule to the Drugs (Prices Control) Order, 1979 also supported the conclusion that it conformed to the required standards.

Conclusion: The imported substance was held to conform to pharmacopoeial standards and was entitled to the claimed exemption.

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