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1998 (8) TMI 194

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....laring the same and without filing any classification list for this item. They were clearing 7 ADCA to their sister concern viz. M/s. Armour Chemicals P. Ltd. for the manufacture of cephalexin on job work basis. The Department was of the view that the benefit of exemption under Notification 122/86-C.E., dated 1-3-1986 was not available to 7 ADCA under which specified intermediate products were exempted as this product did not figure anywhere in the annexure appended to the above notification. Since the department was of the view that 7 ADCA was leviable to duty under CET sub-heading 2921.00 as amine function compound and was not covered by the above notification. A show cause notice was issued on 14-12-1987 demanding duty of Rs. 20,386.99 in respect of 25 Kgs of 7 ADCA manufactured and cleared without payment of duty on 3-6-1987 and proposing confiscation of 279.8 Kgs. of 7 ADCA seized from the assessees factory premises on 24-6-1987. The notice was adjudicated by the Additional Commissioner of Central Excise, Vadodara who accepted the assessees' claim for classification under CET sub-heading 2941.90 as anti-biotics, leviable to nil rate of duty under the Tariff at the relevant poi....

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....intermediate for 7 ADCA preparation. Dehydrated sulfoxide from step 4 is reacted with BSU in presence of TMCS and catalyst. After reaction is over toluene is removed by distillation and 7 APDCA thus prepared is extracted with chloroform. 6. 7 ADCA preparation 7 APDCA in chloroform is reacted with DMA and DMMDCS. Material is further reacted with phosphorous pentachloride followed by isobutanel. To this reaction mixture water is added and thus 7 ADCA is extracted in water. This sq. layer is purified with carbon, to this methanol is added and 7 ADCA precipitated from water with the help of liquor ammonia. 7 ADCA thus prepared is filtered in centrifuge, washed with methanol water mixture and dried to get 7 ADCA product. This is packed in drums. 7. Preparation of catalyst Pyridine is reacted with hydrobromic acid to get pyridine - hydrobromide from the reaction mixture, water is removed with the help of toluene. To this methylene chloride is added. This material is filtered in centrifuge washed with methylene chloride and dried to get pyridine bromide catalyst. This is used as catalyst in step 5. The raw materials required for its manufacture, are the following ....

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....generally useful in therapy; those that are used must confirm to FDA requirements; The most important groups of anti-biotic producing organisms are the bacteria, lower fungi or molds and actinomycetcs. These anti-biotics belong to very diverse classes of chemical compounds. Most of the anti-biotics produced by bacteria are polypeptides (such as tyrothricin, bacitracin, polymyxin). The pencillins are the only important anti-biotics produced by fungi. Actinomycetes produce a wide variety of compounds (actinomycin, streptomycin, chloramphonicol, tetracyclines). The antimicrobial activity (anti-biotic spectrum) of anti-biotics varies greatly; some are active only upon bacteria, others upon, fungi, still others upon bacteria and fungi, some are active on viruses, some on protozoa, and some are also active on neoplasms. An organism sensitive to an anti-biotic may upon continued contact with, develop resistance and yet remain sensitive to other anti-biotics. Certain anti-biotics are used as direct food additives to inhibit growth of bacteria and fungi; among these are nisin, pimaricin, nystatin, and tylosin. Note : A number of anti-biotics have been restricted by PDA, both for direct u....

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....he range of the MIC of Cephalexin, which is between 0.9 to 2.0 UG/ML (page 39). The MIC tests have been carried out for establishing that the 7 ADCA has the effect of inhibiting the growth of micro-organism and is effective at a concentration of a few micrograms per ML in the blood. Shri H.P. Tipnis, Principal of the Bombay College of Pharmacy has deposed in his affidavit, which was placed before the adjudicating authority that "Antibiotics are organic chemicals having capacity to kill or inhibit the growth of micro-organism. There exist various kinds of anti-biotics known in Science, some of them used as it is and some are used by further processing to make still more stronger and broad spectrum anti-biotics. This is a very diverse class of compounds and is often classified and discussed in groups. The groups are classified according to their mode of killing or spectrum of antimicrobial activity. Generally the anti-biotics with similar chemical structure are grouped together. One of the group of anti-biotics is called "Cephalosporin". Cephalosporins are semi-synthetic anti-biotics. The active nucleus, 7 amino-penicillanic acid; both of these consist beta lactum ring. Various compo....

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.... It is possible that in future these anti-biotics may becomes intermediate for a still better anti-biotic and this kind of change continues in the field of anti-biotics. 7 ADCA, has amine function like so many other established anti-biotics like ampicillin, cephalexin, streptomycin, tetracycline, etc. also have. In fact, Amine function is a common group in a number of synthetic and synthetic organic anti-biotics, it can also be mentioned here that 7 ADCA despite of having amine function should be more suitably categorised under the headings of anti-biotic groups." 9. In addition the assessees also relied upon a certificate dated 4-7-1987 from the Assistant Commissioner, Food and Drugs Control Authority, Bharuch, certifying that 7 ADCA manufactured by the assessees is an anti-biotic. The contention of the Revenue that 7 ADCA is not an anti-biotic is based on the following grounds : (a) It is an amine function compound covered by CET sub-heading 2921.00; (b) In the opinion of the Chemical Examiner, it was not an anti-biotic; (c) The Food and Drugs Control Administration, Gandhi Nagar, Gujarat had certified that 7 ADCA was not a drug having any thera....