Exemption for patent medicaments requires all bulk-drug ingredients to satisfy the notification's specified-drug condition.

Notification No. 29/88 granted exemption only to patent or proprietary medicaments based on bulk drugs specified in the First Schedule to the Drugs (Prices) Control Order, 1987, whether used singly or in combination with other specified bulk drugs. A formulation of pyrimethamine and sulphadoxine did not satisfy that condition because sulphadoxine was not shown to be a specified bulk drug in the First Schedule. A departmental letter describing the combination could not substitute for the notification's express requirement. The exemption was therefore not available, and the denial of benefit was upheld.

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Issues: Whether the product, a formulation of pyrimethamine and sulphadoxine, was entitled to exemption under Notification No. 29/88 dated 01.03.1988 for patent or proprietary medicaments falling under Heading 3003.

Analysis: The notification extended benefit only to formulations based on bulk drugs specified in the First Schedule to the Drugs (Prices) Control Order, 1987, either individually or in combination with other specified bulk drugs. Pyrimethamine was a specified bulk drug, but sulphadoxine was not. The departmental letter relied upon only indicated the categorisation of the combination and did not establish that sulphadoxine itself was a bulk drug specified in the First Schedule. On a plain reading of the notification, a combination containing one non-specified ingredient did not satisfy the condition for exemption.

Conclusion: The product was not eligible for exemption under Notification No. 29/88 and the denial of the benefit was upheld.

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