TMI Blog1989 (6) TMI 62X X X X Extracts X X X X X X X X Extracts X X X X ..... oxy benzoate I.P. Magnesium Stearate B.P. Magnesium Stearate B.P. Cellulose Acetate Sodium Lauryl Phthalate B.P.C. Sulphate I.P. Micro Crystalline Dealoa (P) Cellulose Cellulose Acetate Phthalate B.P.C. 2. On 3rd May 1979 a notification was issued under Rule 8 of the Central Excise Rules, 1944, whereby the Central Government exempted patent of proprietary medicines falling under Item No. 14E of the First Schedule to the Central Excises and Salt Act, 1944, and containing one or more of the ingredients specified in the Schedule thereto from so much of the duty of excise leviable thereon as was in excess of 2½ percent ad valorem. Metronidazole was one of ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... om them. 5. The petitioners showed cause. They contended that Flagyl 200 mg. tablets contained 49.5% Metronidazole, 13.86% Calcium Carbonate and 36.63% other excipients and the 400 mg. tablets contained 80% Metronidazole, 4.21% Calcium Carbonate and 15.79% other excipients. It was, therefore, clear that Metronidazole was the only active ingredient in Flagyl tablets which had therapeutic efficacy. The Calcium Carbonate in the Flagyl tablets did not overtake the strength and activeness of Metronidazole. Calcium Carbonate therein was a pharmaceutical necessity which acted as a diluent and was therapeutically inert. 6. It appears that the Collector of Central Excise, Bombay, referred the matter to the Central Board of Excise ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... acid properties but only if used in doses ranging from 1 to 5 grams. In this behalf, reference was made to the British and Indian Pharmacopoeias and Martindale's Extra Pharmacopoeia. The presence of Calcium Carbonate in Flagyl tablets was as a diluent or a pharmaceutical necessity. It was therapeutically inert therein and did not interfere with the therapeutic or prophylactic activity of the Metronidazole which was the only effective ingredient. 9. Mr. Lokur, learned Counsel for the respondents, submitted that the mere presence of Calcium Carbonate in Flagyl tablets, regardless of whether it was active as an antacid or not, precluded Flagyl tablets from the benefit given by the said notification. He submitted that, in any event, th ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... eutic or prophylactic activity of the ingredient or ingredients specified in the Schedule. 12. There is no material to bear out the submission that the Calcium Carbonate is bound to have some antacid effect even in the formulation of Flagyl tablets. In fact, the material that is on record, namely, the pharmacopoeia referred to, shows that to have an antacid effect, Calcium Carbonate must be used in the doses ranging between 1 and 5 grams. There is also the certificate of the Commissioner, Food and Drug Administration, Maharashtra, that the only active ingredient in the Flagyl tablets is Metronidazole. 13. Accordingly, Calcium Carbonate, though it may have antacid properties in the prescribed doses, must be held to be thera ..... X X X X Extracts X X X X X X X X Extracts X X X X
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