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2004 (1) TMI 264

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..... ulphate Dihyrate (c) Lansaparazole pellets (d) Nimesulide (e) Fluexetine Hydrochloride, and (f) Sparflexacon The period involved is from 1996 to February, 1997. The Assistant Commissioner rejected the claim of the assessee for the reason that the assessee had followed the standards specified in Martindale Extra Pharmacopoeia which is not an official Pharmacopoeia of any country. The Commissioner (Appeals) accepted the contention of the assessee that Martindale Extra Pharmacopoeia which is published by Royal Pharmaceutical Society, U.K. is an official Pharmacopoeia. He also took the view that in the light an Explanatory Note in Hyderabad Collectorate's Trade Notice No. 24/95 also the assessee is entitled .....

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..... int publication with British Medical Association and also Martindale. In the nature of the publication, we have no hesitation to hold that Martindale Extra Pharmacopoeia is an official pharmacopoeia of Great Britain. 4. The Commissioner (Appeals) is also justified in holding that the assessee is entitled to the benefit of Trade Notice No. 24/95. Explanatory Note to the Trade Notice reads as follows :- "The Notification No. 8/95-C.E., dated the 9th February, 1995 has been issued keeping in view the Drug Prices Control Order, 1995. It does not extend any fresh concession but seeks to continue. (b) the concessional excise duty of 10% ad valorem on other Bulk Drugs which was earlier available vide Sl. No. 6 of Notification No. 6/94-C.E." .....

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..... hromycin for the period prior to 1-1-97. It was found that during the period roxithromycin could not have been a bulk drug since only a drug which conforms to the standards of identity, purity and strength specified in the Drugs and Cosmetics Act, 1940 could be a bulk drug. Since no such standard had been prescribed either in the Indian or any other official pharmacopoeia of any country, the roxithromycin manufactured by the assessee could not have complied with such standards, and therefore would not be a drug within the meaning of Drugs and Cosmetics Act, 1940. It is seen that the same drug manufactured after 1-1-97 was treated as a bulk drug because it figured in the pharmacopoeia of European community during that period. The ratio of th .....

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