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1998 (3) TMI 508

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..... re of living micro-organism (live yeast cells of Saccharomyces cerevisiae P). The lower appellate Micro-organism is a micro-scopic organism; those of medical interest include bacteria, rickettsiae, viruses, fungi and protozoa (Source-Encyclopaedia and Dictionary of Medicine, Nursing and Allied Health by Benjamin F. Miller, Fourth Edition page 769; McGraw Hill Dictionary of Scientific and Technical Terms, Fourth Edition at page 1197). A culture is the propagation of micro-organism of living tissue cells in special media conductive to their growth and a culture medium is any substance or preparation used for the cultivation of living cells. The process for growing yeast commences with the laboratory culture of a pure strain of saccharomyces cerevisiae P. Yeast is a micro-organism which is propagated in special media i.e. it is cultured in special media. The assessees use an agar medium containing dextrose, peptone, etc. sabouraud dextrose (SAB) for the culture of yeast. The assessee s submission before us that active culture is inactivated or made inert by the process of lyophilization (a method used for preservation of bacteria, etc., by drying them from the frozen state in vacuo) .....

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..... classification lists filed before us show that the respondents had themselves claimed the classification under TI-14E and it was only in respect of bulk drugs that they had claimed TI-68 and what is in question before us is the product Laviest admittedly classifiable under TI-14E. Therefore, the Collector has correctly observed that the A.C. has not properly applied his mind and treated it as a classification dispute whereas it was actually a dispute confined to eligibility to the Notification Nos. 211/69 and 37/85 only and in this respect, he does not say explicitly anything but since, he has finalised the provisional assessment and not extended the benefit of the aforesaid notifications, by necessary implication, the benefit of the aforesaid notifications stands denied to the appellants. Since the respondents (assessees) were aggrieved, they had filed a petition before Collector (Appeals) and succeeded. This time it is Department which was aggrieved and rightly so. It is observed that the Collector (Appeals) has also not examined the matter in depth and contra to his own observation, has proceeded merely on the basis of A.C. s observations regarding classification which was not .....

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..... cified therein including culture of micro-organism . 8. In the present case, the product Laviest is in the form of capsules of dried live yeast as per the pamphlets filed by the respondents. 9. Yeast is a well-known micro-organism known by the biological name Saccharomyces and it has multifarious uses for human beings; And we are all familiar with the baker s yeast. Therefore, the initial question in the mind of the A.C. was not without any rhyme or reason and it was necessary to decide whether it was an item in the nature of baker s yeast falling under TI-68 or a product in the nature of a P P medicine classifiable under TI-14E. However, neither the copy of the show cause notice has been filed nor the reason or basis for his reasoning and deciding this issue has been indicated in the order-in-original. 10. The doubt or question which arose in the mind of the A.C. was correct but, he is obviously incorrect in observing that the respondents had claimed classification under TI-68. 11. However, the fact that the respondents were manufacturing their product under a drug licence and selling their product as P P medicine (in capsules) for prevention and treatment of ga .....

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..... l Terms has already been reproduced in para 4 of this order and what is important to note in this definition of Culture is that it is the propagation of micro-organism or living tissue cells in special media conducive to their growth and a culture medium is any substance or preparation e.g. (solid, gel or liquid) used for the cultivation of living cells (i.e. in/on which the micro-organism lives or grows. 17. The respondents have produced a letter from Haffkins Institute for Training, Research Testing, Bombay dated 9-12-1986 mentioning that the Laviest Capsules of the respondents contain a culture of micro-organism. However, Dr. S.V. Cadre has not indicated the basis of his above observation which was all the more necessary to indicate in the face of the above well-known description and understanding of the meaning of the term culture in medical or biological fields. Once a person, however, eminent, choses to record an observation, opinion or inference different from well-established and well-known perception, provision or preposition, he was all the more required to give the reasons and basis for the same. It is also important to note that this letter is dated 9-12-1986 .....

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..... ure medium (a mixture of nutrients used in the laboratory to support growth and multiplication of micro-organisms). Some micro-organisms can grow in a medium containing only inorganic compounds, whereas others require a medium containing organic compounds (amino acids, sugars, purines or pyrimidines, vitamins, or coenzymes). Some require complex natural substances (peptone, yeast autolysate, blood cells, or blood serum), and some cannot as yet be grown in an artificial laboratory medium and can be propagated only in a living host or living cells. At pages 139, 140, 141 142 of this book, under the heading Maintenance and Preservation of Pure Cultures , it is indicated, inter alia, as follows :- Most microbiology laboratories maintain a large collection of strains, frequently referred to as a stock-culture collection. These organisms are needed for laboratory classes and research work, as test agents for particular procedures, or as reference strains for taxonomic studies. Most major biological companies maintain large culture collections. The strains are used for screening of new, potentially effective chemotherapeutic agents; as assay tools for vitamins and amino acids; as .....

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