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TMI Blog1987 (7) TMI 252X X X X Extracts X X X X X X X X Extracts X X X X ..... e order appealed against that the Central Excise Tariff exempts only such of the pharmacopoeial preparations which are strictly in accordance with the approved formula. It is also held that for purpose of reference the pharmacopoeia relevant is the one recognised under Drug Control Act and Rules in the year relevant to production and not any edition which might have subsequently been recognised. The department therefore dismissed the claim of the appellant company that their product was in accordance with the 1979 edition of National Formulary of India (N.F.I.). 3. It has been held by the department that the product of the appellant company does not satisfy the prescribed requirement of usual strength of 0.5 gram of Metamizole per tablet, ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ector has also held that the appellant company has failed to comply with the requirements of Rule 96 ZN(2) of the Central Excise Rules, 1944 inasmuch the recognised abbreviation for the relevant pharmacopoeia does not appear immediately after the name of the drug on the carton. 8. In their Appeal, the appellants have submitted that they were manufacturing Metamizole (Analgin) N.F.I. Tablets duly authorised by the Drug Controller. The Government analyst M.P. had also declared the product to be conforming to National Formulary of India Standard vide his report No. 2072/72, dated 1st September, 1977. It is submitted that Analgin Tablets of 0.30 grams strength are covered under the second edition (1966) as well as the third edition (1979) of ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... . If, it is submitted, a change is incorporated in 1979 edition it does not mean that such change did not exist before its publication. 11. Appellants contends that there is no basis for the view taken by the Additional Collector that it is against the recognised mode of manufacture of pharmacopoeial medicines that they should be covered by two or more pharmacopoeia. It is also submitted that it is a statutory requirement for the name of the manufacture to appear on the carton and this by itself would not attract classification under Central Excise Tariff Item 14E. This does not show that the appellant had a proprietary right in the medicine. The learned Advocate has in this connection relied on the decision of the Madras High Court in ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... any indication of the identity of that person. Explanation - II. Alcohol , Opium , Indian Hemp , Narcotic Drugs and Narcotics have the meanings respectively assigned to them in Section 2 of the Medicinal and Toilet preparation (Excise Duties) Act. Notification Under Explanation : In pursuance of the Explanation of Item 14E of the First Schedule to Central Excises and Salt Act, 1944 and of the Explanation to Item No. 28A of the First Schedule to the Indian Tariff Act, 1934 (32 of 1934) all editions of the following Pharmacopoeia, Formularies and other publications are notified for purposes of the said Explanation namely :- 1. The Indian Pharmacopoeia. 2. The National Formulary of India. ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... itself says - clearly that all editions (emphasis applied) of the specified Pharmacopoeia, Formulary and other publications - and this includes the Indian Pharmacopoeia and National Formulary of India - are notified for purpose of the Tariff Item. In view of this the department s stand that the 1966 or the 1979 edition would not be applicable to the relevant period is not sustainable and has to be rejected. 15. We have also taken note of the clarification issued under the orders of the Government of India, Ministry of Finance (Department of Revenue Insurance) letter No. 42/22/69-CX. 3, dated 10th July, 1974 which is reproduced below for ready reference : Medicines prepared according to the Indian Pharmacopoeia - (1) In case of prepa ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... uch a preparation should be considered a Pharmacopoeial preparation". 16. A perusal of the foregoing orders of the Government would show that there is no substance in the stand taken by the department that the impugned product cannot be treated as a pharmacopoeial preparations merely because it is being marketed in a strength which is lower than the usual strength . It is clearly laid down that in case of preparations where pharmacopoeia lays down the usual strength and also specifies the dose range, preparations which fall within the dosage range shall be deemed to be pharmacopoeial. We have observed that these orders of the Government were brought to the notice of the Additional Collector who has not examined the appellant s defence in ..... X X X X Extracts X X X X X X X X Extracts X X X X
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