Import restriction on drug complexes: tetracycline urea complex held outside earlier Appendix 9 controls

Tetracycline urea complex was treated as a distinct commercial substance, not the pure drug tetracycline, for import control purposes. The Bombay HC noted that the then-applicable Import Policy did not expressly include complexes within Appendix 9 restrictions on the drug itself, and the later amendment adding salts, esters and complexes showed such items were not covered earlier. The department failed to establish that the imported goods fell within the canalised category, and the fact that tetracycline could be physically separated from the complex did not make the complex the prohibited drug. Import under OGL was therefore permissible.

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Issues: Whether tetracycline urea complex was a canalised drug or its active ingredient falling within Appendix 9 of the Import Policy, so as to bar import under OGL.

Analysis: The imported material was found to be a distinct substance and not the pure drug tetracycline. The relevant policy in force did not expressly include complexes within the restriction applicable to drugs in Appendix 9, and the later amendment in AM-84 specifically added salts, esters and complexes, showing that such complexes were not covered by the earlier policy. The material placed by the department was held insufficient to establish that the imported goods fell within Appendix 9, and the possibility of separating tetracycline by a physical process did not convert the complex into the drug itself.

Conclusion: The import of tetracycline urea complex was permissible under OGL and the restriction under Appendix 9 did not apply.

Ratio Decidendi: A drug complex is not covered by an earlier import restriction on the drug itself unless the policy expressly includes complexes, and a separate commercial substance does not become the prohibited drug merely because the drug can be physically separated from it.

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