TaxTMI 
TaxTMI 
1979 (7) TMI 105
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....use notice for the proposed revision under section 36(2) of Central Excises and Salt Act, 1944 of the order-in-appeal cited above passed by Appellate Collector of Central Excise, Bombay, and their submissions made at the time of personal hearing. 2. The short question to be decided is as to whether the Appellate Collector was correct in holding vide his impugned order-in-appeal that `Analgin Inje....
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....eir letter as `Analgin Injection', USSR-P. 3. Government observe that monograph 67 of the USSR-Pharmacopoeia covers only one preparation of Analgin in powder form. The description of the product is that it is 'A macroacicular, crystalline, odourless, bitterish powder, white or white with a barely visible yellowish tint. Rapidly decomposes in the presence of moisture. Aqueous solutions turn yello....
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....ph 57 itself clearly indicates that one monograph covers only one form of preparation of a particular drug. Therefore, the mere fact that the dosage for injection is specified in monograph 57 would not mean that Analgin Injection is covered by that monograph and should therefore be treated as a pharmacopoeial preparation. In fact in the same USSR-Pharmacopoeial there are separate monographs in res....
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....parate monograph for Analgin Injection, it cannot be said that it is a pharmacopoeial preparation. The approval of Food and Drugs Administration, Maharashtra in the form given for the manufacture of the injections by party merely authorises them to manufacture the product described by the party as Analgin Injection USSR-P. It is no substitute for the requirement of a separate monograph for a produ....