TaxTMI 
TaxTMI 
1994 (11) TMI 132
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....ugh the epithelium or mucous preparation lining the vagina. The administration of this medicine is not against any topical or local infection but is directed at the internal infection of vagina resulting from the oral functional system. By absorption into the system its effect is to remove the vaginal infection. It is primarily used to cure vaginal discharge resulting from oral functioning of the system. It acts like oral antibiotic. 3.The appellant was being granted exemption on the suppositories by the department till five notices were issued on 11th June 1980, 17th June 1980, 9th October 1980, 24th January 1981 and 8th May 1981 raising demand for the period 1st September 1979 to 31st May 1980, 1st January 1979 to 31st August 1979, 1st June 1980 to 31st August 1980, 1st September 1980 to 31st December 1980 and 1st January 1981 to 30th April 1981 respectively. The basis for the notices for short levy was that the medicine produced by the appellant was neither for oral nor parenteral use. In reply it was claimed that, `Kemicetine Vaginal Suppositories' were treated by the Drug Control authorities as life saving drug. And the produce was classified by the department for concessiona....
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....69-C.E., dated 3rd May 1969 was issued in exercise of powers conferred by sub-rule (1) of Rule 8 of the Central Excise Rules, 1944 exempting patent or proprietary medicines falling under Item 14 of the 1st Schedule of the Central Excises and Salt Act, 1944 (Act 1 of 1944) and containing one or more of the ingredients specified in the Schedule annexed from so such of the duty of excise leviable thereon as was in excess of 2½% ad valorem. In the Schedule serial No. 14 read as under : Chloramphenicol and its esters for oral and parenteral"14. use;" On 19th June 1980 column 2 of the Schedule was amended and the amended entry provided that in the said notification for the words and figures, `that from so such of the duty of excise leviable thereon as is in excess of two and half per cent ad valorem', the words, `from the whole of the duty of excise leviable thereon' shall be substituted. Therefore any patent or proprietary medicine if it fell in Item No. 14 of the Schedule it became wholly exempt from payment of duty. 5.For exemption two conditions were required to be satisfied - one, that the patent and proprietary medicine should have been produced out of one or more ingredients s....
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....testinal tract." The author while discussing parenteral products has observed that parenteral preparations could be divided in three factors - one, drug pellet absorption; two, solution absorption; and three, parenteral dispersion absorption. It is explained in `The Basis of Pharmacology, Second Ed. by Avram Goldstein, Lewis Aronow and Summer M. Kalman as under : "The possible routes of drug entry into the body may be divided into two classes - enteral and parenteral. In enteral administration the drug is placed directly in the gastrointestinal tract by placing it under the tongue (sublingual), by swallowing it (oral), or by rectal administration. In parenteral administration the gastrointestinal tract is by-passed. There are many parenteral routes. The commonest are subcutaneous (s.c.), intramuscular (i.m.), and intravascular : but drugs may also be applied to the skin or injected intradermally, for local effect or to be absorbed percutaneously : they may be inhaled for direct action on the bronchial tree or to be absorbed into blood at the alveoli : they may be injected into or near the spinal canal : they may be introduced intravaginally" [Emphasis supplied] The Tribunal itse....
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....e understood that there is no need, for the drug to operate effectively, to penetrate and be absorbed systemically, because, as we have seen, the infections are all local in the vulva, vagina and cervix region. The paper indeed does not suggest anywhere that for the treatment of these maladies, there is any need for systemic absorption of the drug. The reason for this is obvious. The target areas are all superficial - that is - not inside the system but outside the internal body system, although in a protected/covered cavity or orifice. M/s Mac Laboratories have not shown any evidence to satisfy us and to convince us that their kemicetine vaginal suppositories are parenteral in their activity is to combat infecting organism which lies on the surface of the body system itself." 8.Medicines used through vaginal route could, thus, be parenteral if its administration according to Tribunal was for systemic absorption. But since KVS produced by the appellant was for local absorption it could not be held to be parenteral. Whether the approach of the Tribunal is correct or not but this appears to be certain that the word `parenteral' is wide enough as bronchial inhalers have come to be in....
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....he appellant was refused as the suppositories produced by the appellant were for local absorption. It has been explained that the ambit of the word `parenteral' is very wide. Its use in the Notification has been in still wider sense. The use of the word `oral' for `enteral' and `parenteral' for injections in the Notification is not without purpose. Enteral administration of medicine may be sublingual, that is, `absorption of drugs by oral mucous membrane producing systemic effects' or oral, `one of the most popular routes of administering drugs in the form of tablets, capsules, mixture, powder, pills, emulsions or rectal' of local or topical, that is, the administration of drug for systemic actions specially in vomiting, unconsciousness and when intestinal absorption is to be avoided. The Government even though it was aware of the word `enteral' decided to use the word `oral' in the Notification obviously so that there may not be any ambiguity. In technical sense sublingual administration may be different from oral but in the common and popular sense a medicine taken sublingually is as much oral as a tablet or capsule or mixture taken by a patient. Similarly the word `parenteral' w....