Bulk drug exemption upheld where Tinidazole satisfied the definition and deputy-issued certification was accepted.

Tinidazole was treated as a bulk drug for exemption under Notification No. 234/86-C.E. because it was supported by recognised drug references and a competent authority's certification that it was used for diagnosis, treatment or prevention of disease. The notification was construed to require compliance with the substance of the bulk drug definition, not a narrow reading, so the exemption remained available. A certificate issued by the Deputy Drugs Controller was also accepted as sufficient, because the requirement related to the Drugs Controller's office rather than a particular signatory's designation. The revenue challenge to the exemption therefore failed.

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Issues: (i) Whether Tinidazole qualified as a bulk drug entitled to exemption under Notification No. 234/86-C.E. dated 03.04.1986. (ii) Whether the certificate issued by the Deputy Drugs Controller satisfied the notification requirement of a certificate from the Drugs Controller.

Issue (i): Whether Tinidazole qualified as a bulk drug entitled to exemption under Notification No. 234/86-C.E. dated 03.04.1986.

Analysis: The product was shown to be included in recognised pharmacopoeial and technical drug references, and the competent authority had certified that it was a bulk drug used for diagnosis, treatment or prevention of disease. The notification's explanation required the product to answer that description, and once that requirement was met, there was no basis to deny the exemption merely on a narrow reading.

Conclusion: Tinidazole qualified as a bulk drug and the exemption was available.

Issue (ii): Whether the certificate issued by the Deputy Drugs Controller satisfied the notification requirement of a certificate from the Drugs Controller.

Analysis: The requirement was treated as one relating to the office of the Drugs Controller rather than the personal signature of a particular designation-holder. A certificate issued by a senior officer in that office was regarded as sufficient compliance with the notification, and the defect, if any, was treated as inconsequential.

Conclusion: The certificate issued by the Deputy Drugs Controller was sufficient compliance with the notification.

Final Conclusion: The Revenue's challenge to the grant of exemption failed, and the assessee remained entitled to the benefit of the notification.

Ratio Decidendi: Where the product satisfies the substantive definition of a bulk drug under an exemption notification, and the prescribed certificate is issued by a competent officer of the designated office, the exemption cannot be denied on a hyper-technical objection to the signatory's designation.

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