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TMI Blog2000 (2) TMI 128X X X X Extracts X X X X X X X X Extracts X X X X ..... tor, Rs. 10,000 on Shri Ramamurthy, Manager and Rs. 5000/- on Shri V.R. Sundaraman, Executive (Excise). The Collector also ordered confiscation of Plant Machinery with an option to redeem the same on payment of fine of Rs. 10,000/- holding that the impugned product is capable of curing osteoporatic disease and also counteracts periodical disease due to pregnancy and is prescribed for various ailments; that the impugned product has been classified as 'Ethical Drug' by the Appellants themselves; that it is a patented product mentioned in the Martindale Extra Pharmacopoeia itself. She gave the findings that the therapeutic and prophylactic properties of OSSOPAN were well established by documentary evidence, oral admission and corroborated by the opinion of the State Drug Controller of Tamilnadu; that there are several medical journals which extol the efficacy of OSSOPAN as drug in treatment of several diseases connected with bones, fracture of bones, pregnancy, etc.; that TTK's own bio-data of the products is replete with reference to OSSOPAN being a drug; that it is marketed under the strict control of the State Drug Controller. She also held that there had been wilful suppression ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... not having therapeutic property, is not a medicament classifiable under Heading 30.03 of the Tariff. The learned Advocate also submitted that there is no basis in the impugned order to treat osteoporosis as a disease state, that reliance by the Collector on Martindale Pharmacopoeia is incorrect as, according to the preface to Martindale Pharmacopoeia, "Martindale is based on published in formation. It is not a book of standards. Inclusion of a substance or a preparation is not to be considered as a recommendation for use". He mentioned that OSSOPAN has all the characteristics of a dietic food and the same is applied mainly natural physiological instances. He referred to "Manual of Dietetic Practice", edited by Briony Thomas, according to which OSSOPAN is proprietary energy and nutrient supplement. He also referred to Doctors' Desk Reference, 1990-91, VII Edition in which it is mentioned that OSSOPAN Tablets/suspension promotes remineralisation and stimulates osteogenesis; that the product was mentioned under 'Product Information (Nutrition)'. He also mentioned that even in Martindale Pharmacopoeia, Hydroxyapatite has been described as a natural mineral with composition similar to ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ious findings of the Collector to submit that the impugned product is a medicament. He specifically referred to paragraphs 36, 39, 52 55 of the impugned order. He mentioned that M/s. Robopharm who were the manufacturer of OSSOPAN and who transferred the know how to the Appellants have treated it as a drug and introduced in the market only after clinical tests as is evident from the Publication 'OSSOPAN' released by them. It is claimed therein that the impugned product is capable of curing osteoporatic disease and also counteracts periodical disease due to pregnancy; that it also indicates that OSSOPAN is a drug prescribed for various ailments, some of which are : It speeds fracture healing in elderly patients.(i) (i) It speeds fracture healing in elderly patients. (ii) OSSOPAN increases the rate of weight gain in poorly thriving infants. (iii) OSSOPAN improves the general condition and shortens convalescence. (iv) It counteracts periodonatal disease due to pregnancy. (v) The stimulation of bone formation by OSSOPAN prevents the progression of Osteoporosis; etc. 7. The learned SDR also referred to Martindale Pharmacopoeia which refers to the following study and repor ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... n in which they had mentioned that mention of "Extract of bone of young animals" made many doctors shy away from prescribing the product and they had requested the Drug Controller to permit them to use Hydroxyapatite which finds a place in Martindale, the Extra Pharmacopoeia. Finally, the learned SDR mentioned that their intention to evade the payment of duty is apparent from the letter dated 15-7-1992 of their Managing Director addressed to their Hyderabad factory wherein it was mentioned that the presentation of their case has been weakened as someone has handed over the OSSOPAN Forte literature; that OSSOPAN Forte mentioned therapeutic superiority of OSSOPAN in osteoporosis. It was also mentioned in the said letter that in Pallavaran they had avoided any description regarding therapeutic OSSOPAN. The learned SDR also contended that in view of these facts the penalty imposed not only on appellant company but on the Managing Director and other officials of the appellant company is justified as they had suppressed information or made misdeclaration. Regarding availability of Modvat credit he submitted that question of availability of Modvat credit was not an issue before the Collec ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... pable of use either for therapeutic or prophylactic purposes. 10.We have considered the submissions of both the sides. It is an admitted fact that appellant company has been manufacturing OSSOPAN since 1961 which was being classified as patent or proprietary medicament under Tariff item 14E of the erstwhile Central Excise Tariff. It is also not disputed by the appellants that even after introduction of present CETA w.e.f. 28-2-1986, the impugned product OSSOPAN was classified by them under Heading 30.03 as a medicament. According to the appellants' own submission they changed the classification of the impugned product as their competitor American Remedies, manufacturer of product Natcol, similar to impugned product was classified by the Assistant Commissioner, Madras under Chapter 2 of the Tariff. Now the Tribunal in American Remedies v. CCE, Madras, 1999 (111) E.L.T. 517 has held that the product Natcol obtained as raw material by the appellants is subjected to a complicated manufacturing process and not only this results in the product changing its physical form of powder into tablets or liquid suspension, but a number of chemicals are added to it to give it a desired flavour ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... idity rate of the disease. According to Butter Worths Medical Dictionary, Osteoporosis means "rarefaction of bone, localised rarefaction of the bones of the skull; Schueller's disease." According to Harrison's Principles of Internal Medicine, published by McGraw-Hill Books company, Health Professions Division, "Osteoporosis - A reduction of bone density below level required for mechanical support. Remodelling of bone (formation and resorption) is continuous, and density decrease whenever rate of resorption exceeds formation. Vertebrate, Wrist, hip, humerus, and tibia, are particularly prone to fracture." One of the treatment suggested is oral calcium. From the technical books, their own publication and Martindale, The Extra Pharmacopoeia, it is apparent that the impugned product is a medicament having therapeutic and prophylactic uses and as such is classifiable under Heading 33.03 of the Central Excise Tariff. As OSSOPAN is held to be a medicament under Heading 30.03 of the Tariff even the veterinary grade cannot be classified under Heading 23.02 as a food supplement. 12.We, however, find sufficient substance in the submissions of the learned Advocate that the demand for Centra ..... X X X X Extracts X X X X X X X X Extracts X X X X
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