Ophthalmological use exemption applies where a formulation also has other therapeutic uses, if the notification does not require exclusivity.

A formulation with ophthalmological use was held entitled to exemption under Notification No. 29/88-C.E. because the notification excluded only formulations based on certain bulk drugs for therapeutic use other than ophthalmological use, and did not require exclusive ophthalmological use. Since the product's ophthalmological use was undisputed, the exemption could not be denied merely because it also had other therapeutic uses. The notification language was treated as clear and unambiguous, and the product qualified for the benefit claimed.

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Issues: Whether Bidicycline, being a formulation having ophthalmological use as well as other therapeutic uses, was entitled to the benefit of Notification No. 29/88-C.E. dated 1-3-1988.

Analysis: The product's ophthalmological use was not disputed. The notification excluded formulations based on certain bulk drugs for therapeutic use other than ophthalmological use, but it did not require exclusive ophthalmological use. Since the formulation had ophthalmological use, the exemption could not be denied merely because it also had other therapeutic uses. The language of the notification was held to be clear and without ambiguity.

Conclusion: The product was entitled to the benefit of Notification No. 29/88-C.E. dated 1-3-1988 and the appeal succeeded.

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