Pharmacopoeial classification of Phenol U.S.P. upheld exemption; actual end-use was not required under the notification.

Phenol U.S.P. was treated as a drug because it appeared in the Indian, British and American Pharmacopoeias, bringing it within the exemption for drugs, medicines, pharmaceuticals and drug intermediates. The notification was construed as granting exemption to the specified article itself, and the pharmacopoeial references to the Drugs and Cosmetics Act, patents or trade marks did not narrow its scope. Proof of actual end-use as a drug or drug intermediate was not required, and the exemption could not be denied on that basis.

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Issues: Whether phenol U.S.P. was covered by the exemption notification as a drug or drug intermediate, and whether exemption depended on proof of actual end-use.

Analysis: Phenol was shown to be included in the Indian, British and American Pharmacopoeias, which established that it was a drug and therefore fell within the description of drugs, medicines, pharmaceuticals and drug intermediates exempted by the notification. The reference in the pharmacopoeial foreword to compliance with the Drugs and Cosmetics Act, 1940, and to patents or trade marks did not control the construction of the exemption notification. The notification granted exemption to the specified articles themselves and did not import any condition that they must be used in a particular manner. The contention that the exemption was unavailable unless actual end-use as a drug or drug intermediate was proved was rejected.

Conclusion: Phenol U.S.P. was entitled to exemption under the notification, and actual end-use was not a relevant condition for the exemption.

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