1. The dispute here is whether Rolitetracycline is Tetracycline hydrochloride or not. The Appellate Collector of Central Excise and Customs, Bombay said in his order No. 847/78 dated 11-8-78 that Rolitetracycline intramuscular injection was not eligible to the concession of notification 116/69-CE because it contained lignocaine hydrochloride an anaesthetic 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 26-7-83, 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 Alfred Gilman; Code of Federal Regulations; Federal Register, The National Archives of the United States; National Formulary XIV : National Formulary Board of American Pharmaceutical Association ; product leaflets of Reverin intravenous and Reverin intramuscular and labels of Reverin intravenous and Reverin intramuscular. He argued that these authorities show that tetracycline hydrochloride and Rolitetracycline are synonymous. The one is not different from the other. In respect of the Rolitetracycline intramuscular injection, he argued that Lignocaine hydrochloride was a local anaesthetic to lessen the pain which is quite severe in intramuscular injection. The anaesthetic has no therapeutic value nor does it interfere with the therapeutic or prophylactic action of the active ingredient tetracycline.
3. The learned Counsel for the department opposed the appeal and said that Rolitteracycline was not the same as tetracycline hydrochloride.
The two may have similar properties and Rolitetracycline may be used where tetracy-cline hydrochloride was indicated but that is not the same thing as being the same substance so as to gain the same exemption. There is no authority to say that they are the same substance chemically. The intramuscular injection contains Lignocaine hydrochloride an anaesthetic. An anaesthetic has a well-known therapy value and actively takes part in treatment of diseases.
4. We have read the authorities produced by Hoechst but none of them states that Rolitetracycline is a hydrochloride of tetracycline. The Martindale- The Extra Pharmacopoeia (Ainley Wade) describes Rolitetracycline (USNF) PMT : Pyrrolidino methyl tetracycline N (I 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 hydro-chloride, when an initial high blood concentration is essential or when oral administration is impracticable. It is given by deep intramuscular or slow intravenous injection, usually as rolitetracycline nitrate." The Pharmacological Basis of Therapeutics-Third Edition (1968) -Louis S. Goodman and Alfred Gilman carries a paragraph on chlorotelracycline hydro-chloride NF (avrcomycin hydrochloride), Oxytetracycline Hydrochloride NF (terramycin hydrochloride), (tetramycine hydrochloride US) (achromycin V, panmycin hydrochloride, polycycline hydrochloride, steclin tetracyn hydro-chloride) and Demethyl chlorotetracycline hydrochloride, NF (declomycin). These are said to be available in a wide variety of forms for oral and parenteral administration. The bases of oxytetracycline and tetracycline are said to be official but there are said to be also many preparations which are not official, one of them being volitetracycline the Npyrro lidino methyl derivate of tetracycline. It is reported to be more soluble than the present compound and has been proposed for parenteral administration. The book also reports that tetracycline hydrochloride (combined with xylocaine) is available for intramuscular injections. [Xylocaine appears to be a local anaesthetic.] The Code of Federal Regulations, published by the Federal Register, The National Archives of the United States describes rolitetracycline as the cyrtalline N-Pyrro lidino methyl) derivative of a kind of tetracycline. It is reported 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: We can see from all the authorities we have quoted that care is taken to show that rolitetracycline is only similar to tetracycline hydrochlpride 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, tetracycline is given as rolitetracycline citrate. Another publication Pharmacological Basis of Therapeutics reports that while several forms including tetracycline hydro-chloride USP forms have bases that are official, there are preparations that are not, and one such is rolitetracycline, a derivative of tetracycline. It is evident from this that the forms if not the bases are different and hence while one is official the other is not.
5. The problem is not that rolitetracycline can or cannot do the work of tetracycline hydrochloride because we are satisfied that it can, but whether it can take its place for the purpose of the exemption. It is not that the exemption can never be earned because tetracycline hydrochloride is not a form putout for prescription for the treatment of diseases. Tetracycline hydrochloride is known and can be prepared and therefore can be put forward as a claimant to the exemption. So even if rolitetacycline does practically everything tetracycline hydrochloride does, it is not the latter, and cannot usurp the claims of the latter as the latter has not yet given up its title, so to speak, but could still assume it. That it may not do so will not improve rolitetracycline's claim. If it does not claim the concession because it is a non-existent product or because it is a product that cannot appear as a claimant in the circumstances in which the exemption is given, there might well be a reason to look again at the question whether it should not, after all, be the product to which the concession can be or, perhaps, should be given, because denial would result in a position where the only product that can earn the concession is refused it and so leaving unused an exemption that reason would dictate should be given to that product.
Such is not the case here and we have demonstrated as much. The denial of the concession to rolitetracycline was, therefore, correct.
6. The question about the lignocaine hydrochloride in the intramuscular injection is resolved now, because neither the intravenous nor the intramuscular injection can avail the exemption under notification No.116/69-CE.