TMI Blog1983 (8) TMI 294X X X X Extracts X X X X X X X X Extracts X X X X ..... thetic a substance he did not accept was therapeutically inert. However, he remained silent on the dispute about Rolitetracycline intravenous injection which M/s. Hoechst claimed was tetracycline hydrochloride but which the Assistant Collector held was not and so disentitled from the concession which was given on tetracycline hydrochloride. M/s. Hoechst has, therefore, filed this appeal ACC/EX/1177, dated 22-12-1978. 2. At the hearing on 26-7-1983, the learned Counsel for M/s. Hoechst argued that all authorities say that Rolitetracycline was nothing but tetracycline hydrochloride. He referred to Martindale, The Extra Pharmacopoeia 26 Edn : Ainley Wade; the Pharmacological Basis of Therapeutics Third Edition (1968) Louis S. Goodman and Al ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... racycline is a hydrochloride of tetracycline. The Martindale The Extra Pharmacopoeia (Ainley Wade) describes Rolitetracycline (USNF) PMT: Pyrrolidino methyl tetracycline N (1 Pyrrolidinyl methyl) tetracycline. It also carries a note that 275 mg. of rolitetracycline is approximately equivalent to 250 mg. of tetracycline hydrochloride, but it does not say that it is the same substance as the latter. It describes the toxic effects, precautions, antimicrobial action, absorption and fate as all being the same as or similar to tetracycline hydrochloride. But it also contains a sentence which says that : rolitetracycline may be used for the treatment of infections due to organisms sensitive to the tetracyclines, as described for tetracycline h ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ted to be used for both intravenous and intramuscular injections. The structure for rolitetracycline is given in the monograph. Therapeutic Agents thus : [Hoechst, however, have submitted a paper on the technical character of rolitetracycline in which the structure of tetracycline hydrochloride is given thus But it is not known what the authority for this is.] We can see from all the authorities we have quoted that care is taken to show that rolitetracycline is only similar to tetracycline hydrochloride and has the same general therapeutic and anti-microbial as well as toxic effects. But not one says the two are the same substances. In fact, we read in some of them that for deep intramuscular or slow intravenous injection ..... X X X X Extracts X X X X X X X X Extracts X X X X
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