9911796707
TMI Blog1998 (3) TMI 351X X X X Extracts X X X X X X X X Extracts X X X X ..... ave mentioned that they are the manufacturers of Dyes, Dye-intermediates, Chemicals, Bulk drug-intermediates, Chemicals, Bulk drug, drug-intermediates and holds valid licences for the manufacture of finished products. The appellants also manufacture D.C.P. I.P., Urethane, Halazone NF and claimed exemption under Notification No. 62/78, dated 1-3-1978. The classification list Nos. 2/78 and 4/78 were filed claiming exemption under Notification No. 62/78 which were approved also. 4. In the light of test report by the Chemical Examiner, Baroda. The show cause notice was served for the period 1-3-1978 to 29-6-1983 under Section 11A of the Act. The Additional Collector rejected the exemption claimed by the appellant. Hence this appeal. 5. It w ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... drug would not by itself entitle it to be termed as Drug/Drug intermediate. the party s contention that since the Director, Food and Drug Control Administration has certified the product Halazone N.F. as drug and the same was included in N.F. XIIV as well as USP XX and that the same conforms strictly to the specifications of National Formulary and Pharmacopoea, the product deserves to be classified as Bulk drug, is not acceptable in as much as for the purpose of food and drugs control administration that particular department may be using the words `drugs in a loose fashion and also all the items figuring in National Formulary and Pharmacopoea, are not necessarily drugs but these also include specifications/standards for raw materials for ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... drug intermediate. In any eventuality this conclusion of the chemical examiner and the order of the Addl. Collector based thereon does not appear to be correct in the light of the relevant technical literature. The records before us show that the appellants had referred to the licence issued by the Controller of Drugs, Gujarat State and claimed that the authority had accepted it as a drug/drug intermediate and also referred to the Indian Pharmacopoea and further they had also enclosed a technical note on chemical reaction involved in the manufacture of Meprobamate forwarded by Geoffrey Manners and Co. Ltd. on August 31, 1982. This note mentions inter alia as follows :- The production of Meprobamate using Urethane as one of the intermediat ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... own that in the provisions with which we are concerned the term has been used in a different sense, we have to take serious note of what the authorities created under other relevant laws have to say. 10. In any eventuality since the submission of the appellant regarding the licence issued by the Drug Controller has not been contradicted or shown to be wrong, we are inclined to take note of it. Further more for the purpose of considering whether the item is a drug or drug intermediate it is sufficient from our point of view to observe that G.G. Hawley declares Urethane (grade N.F.) as an intermediate, inter alia, for medicines. 11. In the circumstances, we accept the appellant s contention regarding Urethane and set aside the orders of t ..... X X X X Extracts X X X X X X X X Extracts X X X X
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