Exemption classification turns on substance identity, not mere therapeutic similarity, and rolitetracycline failed the tetracycline hydrochloride test.

Rolitetracycline was considered for exemption under Notification No. 116/69-C.E. on the footing that it was therapeutically and antimicrobially similar to tetracycline hydrochloride, but the material did not establish identity of substance. The distinction between a base product and its derivative or form was treated as material for exemption purposes, so functional similarity alone was insufficient. On that basis, rolitetracycline could not be substituted for tetracycline hydrochloride, and the exemption claim failed. The separate presence of lignocaine hydrochloride in the intramuscular injection did not alter the result.

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Issues: Whether rolitetracycline could be treated as tetracycline hydrochloride for claiming exemption under Notification No. 116/69-C.E., and whether the presence of lignocaine hydrochloride in the intramuscular injection affected the claim.

Analysis: The available medical and pharmacological material showed that rolitetracycline had similar therapeutic and antimicrobial properties to tetracycline hydrochloride, but did not establish that both were the same substance. The distinction between the form or derivative and the base product was treated as material for exemption purposes. Since tetracycline hydrochloride itself remained a known and claimable product, rolitetracycline could not take its place merely on the ground of functional similarity. In view of that conclusion, the separate point relating to lignocaine hydrochloride did not assist the claim for exemption.

Conclusion: Rolitetracycline was held not to be tetracycline hydrochloride for the purpose of the exemption, and the concession under Notification No. 116/69-C.E. was denied.

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