TMI Blog1996 (7) TMI 212X X X X Extracts X X X X X X X X Extracts X X X X ..... goods found in the said consignment and the samples were forwarded to SIIB. The department scrutinised a technical literature and found that the goods were immunoassay kits based on menoclonal antibodies for qualitative detection of HCG (Human Chorionic Gonadotropin) which is a glycoprotein which can be detected in the urine of pregnant women. The principle of the test is described as follows : Clearview HCG utilises a unique technology. The test is performed by simple addition of the patient s urine to the absorbent pad in the sample window. The absorbent pad is in contact with a test strip which contains regions of immobilised antibody. Urine moves up the test strip and mobilises blue beads attached to an anti-HCG monoclonal antibody which then moves further up the strip. If HCG is present at levels of 50 miu/ml or greater a blue line should become visible in the Result Window. The Result Window remains clear if the test is negative. Clearview HCG also provides an integral control feature. A blue line appears in the control window to show that the test is complete and has worked correctly." The department inferred that there was no mention of any enzyme or of the term ` ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... acturer, Unipath Limited, U.K. have also in their invoice described the said goods as clear view HCG, new Generation Elisa Diagnostic Test for pregnancy; that the manufacturer Unipath Limited, has issued certificate to the effect that the said CLEARVIEW HCG Pregnancy Test manufactured by them is a new Generation Elisa Test; that their clients were importing the said goods CLEARVIEW HCG Elisa Diagnostic Test under a Drug Import Licence issued by the Drugs controller and the said licence is also in respect of CLEARVIEW HCG Pregnancy Test (Elisa Test Kit); that it is evident from the licence that the Drugs Controller had satisfied himself that the said CLEARVIEW Pregnancy Test is an Elisa Test. Photocopies of purchase order, invoice of supplier, certificate issued by manufacturer, Unipath U.K. and the licence issued by the Drug Controller for import of the said goods were also enclosed. (5) That it is alleged in the show cause notice that their clients wilfully misdeclared the said goods; that their clients submit that no justifiable reasons are stated in the show cause notice for coming to the conclusion except a reference in relation to a technical literature that there is no ment ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ied that `Card+ O S H C G Urine Test from Pacific Biotech which is based on colour conjugate dye system is an immunoassay and works on the principle of Elisa and is thus called a Rapid Elisa Diagnostic Test; that their clients would rely upon the said clarification when produced at the time of personal hearing; that CLEARVIEW Chlamydia has been classified as one of the types of Elisa in one of the scientific articles, which is a member of CLEARVIEW Series of products and works on the principle of CLEARVIEW HCG. A copy of the scientific article referred above was enclosed. It was further stated that the contents of the said article goes to show that CLEARVIEW Chlamydia test has been classified as an Elisa and works on the principle of Elisa. (8) It was further submitted that even from the statement of Dr. I.J. Singh, Plant Manager of their clients, it is clear that although there is no conventional enzyme present, the principle involved and the various literature on the subject clearly establish that the test system of CLEARVIEW HCG Diagnostic Test is a New Generation Elisa, that the CLEARVIEW HCG New Generation Elisa Test is the latest in the upgraded series of Elisa Technique w ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... view of their submissions as above it is amply clear that the said product, is in fact, an Elisa Diagnostic Test and the benefit of exemption from duty in terms of Notification No. 208/81 cannot be denied because S.No 155 of the said notification exempts Elisa diagnostic test from payment of customs duty; that they are fully justified in classifying the product under chapter sub-heading 3822.00 and availing the exemption under Notification No. 208/81. 3. The importers also produced certificates issued by the following : (a) Dr. Ajit N. Pendharkar (b) Dr. Jayesh J. Sheth (c) Breach Candy Hospital Research Centre (d) Rawal Nursing Home Research Centre (P) Ltd., New Delhi. 4. The learned Collector after due consideration of the material on record held that : I find that assertions made by the party as above seem to be correct. It has further CLEARVIEW HCG imported; by them is known the world over among the maunufacturer and users as the latest technique for detection of pregnancy which is based on the principles of Elisa and is an Elisa Diagnostic Test. In Elisa and is an Elisa Diagnostic Test. In support of their contention they have inter alia relies upon the foll ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... n is expressed is based purely on a technical interpretation of the information given in the literature of the product, without taking into account as to who the product is known or understood in the medical circles and in commercial parlance. The extracts from Hand Book of Practial Immunology cited by the department, while describing the technical principle of Elisa also does not rule out the interpretation. It is well settled that in the matter of interpretation of exemption notifications, reliance is to be placed on common or trade parlance and not on technical or scientific meaning of the words used. For this, I draw support from the decision of the Hon ble Supreme Court in the following cases :- (1) Collector of Central Excise, Kanpur v. Krishna Carbon Paper Co. - 1988 (37) E.L.T. 480 (SC).................................". 5. The revenue is aggrieved with this order and it is contended that the ld. Collector should have proceeded on the importer s assertion that the principle of the CLEARVIEW HCG TEST imported by them satisfied all the principles of ELISA test described in Handbook of Practical Immunology, except that it has colour conjugate system, instead of a convent ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... Test based on antigent. The antibody reaction and enzyme had been replaced by colour conjugate. It works out on Elisa principle. The item is nothing but Elisa Test and the purpose is the same i.e. to carry out the pregnancy of the test. He submitted that the term Elisa Test is a test to carry and find out the pregnancy by testing the urine of a pregnant woman. The imported item is utilised in the same Elisa test and the principle of carrying out the pregnancy test is same as Elisa principle. He sunmits that the Medical Fraternity had recognised the imported item as a scientific advancement in the Elisa test; wherein the enzyme had been replaced by colour conjugate in order to give more perfect and better results. He referred to the certificate issued by several experts who had certified that they had used CLEARVIEW HCG test for early detection of pregnancy which is based on principles of Elisa technique which is highly accurate and sensitive. The said view had been expressed by Dr. H.S. Ahuja of Breach Candy Hospital and Research Centre. Likewise, Dr. Ajit N. Pendharkar, Consulting Pathologist had also certified that CLEARVIEW HCG is a New Generation Elisa Test for early detection ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... as Elisa Test. He also relied on the few judgments of the Hon ble Supreme Court rendered in the case of Asian Paints India Ltd v. Collector of Central Excise, as reported in 1988 (35) E.L.T. 3 wherein the Hon ble Supreme Court has held that where the definition had not been defined in a tariff, then it must be construed in its popular sense and not according to scientific or technical meaning. He also relied on the judgment rendered in the case of Collector of Central Excise, v. Krishna Carbon Paper Co. as reported in 1988 (37) E.L.T. 480 wherein the Hon ble Supreme Court has held that the trade meaning is one which is prevalent to that particular trade, where the goods is known or traded and hence trade meaning is required to be accepted. He also relied on the judgment of Delhi Cloth General Mills Co. Ltd. v. State of Rajasthan Others as reported in 1980 E.L.T. 383 (SC). 8. We have carefully considered the submissions made by both the sides and have perused the literature. The question that arises for consideration is as to whether the imported item namely one consignment of Pregnancy Detection Kits/Test which has got a trade name CLEARVIEW HCG satisfied S. No. 155 namely, ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... Drug for import CLEARVIEW HCG Pregnancy Test Elisa Test is mentioned. 9. The Collector has also referred to the article titled `Koala Chlamyedia detection made easy appearing in the Current Topics in Today s Life Science, Dec., 1990. Besides, the Collector has relied on all the certificates issued by the experts which has already been referred to above. We have extracted the reply given by the importer as well as the finding portion of the matters to make the point clear as the matter is a technical one. The point which is required to be considered is as to whether any advancement made in scientific field to bring out a new innovation and same having been recognised both in medical field and by licencing controller, will these factors negative the conclusion that absence of enzyme in the item by replacing it by a colour conjugate system, will be itself take away the item from the ambit of the description in the notification namely, Elisa Diagnostic Tests . The answer has to be given clearly in the negative. The reason being that Elisa Test refers to pregnancy test carried out on the urine of a pregnant woman. The improvement has been made to make the test more clear and ..... X X X X Extracts X X X X X X X X Extracts X X X X
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