Financial Daily from THE HINDU group of publications Monday, May 15, 2006 |
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Courts/Legal Issues Industry & Economy - Medical & Surgical Equipments Columns - Case Sensitive Matters of the heart D. Murali
Angiography is "a procedure performed to view blood vessels after injecting them with a radio-opaque dye that outlines them on Xray"
All about THE HEART and its health. R. Shivaji Rao In Act V, scene III, of Troilus and Cressida, the Bard laments, "Words, words, mere words, no matter from the heart." Just the way one would normally feel, when reading tax literature. For, the taxman is often perceived as "one whose hard heart is button'd up with steel," as says Dromio of Syracuse in The Comedy of Errors. Wipro GE Medical Systems Ltd should have felt likewise, when the Commissioner of Customs denied it the benefit of a Notification. The story begins in 2001 when Wipro imported `cardiac vascular angiography system including digital angiography' and claimed benefit of exemption Notification No. 17/2001-Cus., dated March 1, 2001 under Sl. No. 348. For starters, angiography is "a procedure performed to view blood vessels after injecting them with a radio-opaque dye that outlines them on x-ray," as www.medterms.com defines. "This technique can be usefully used to look at arteries in many areas of the body, including the brain." Vascular angiography is performed via a small tube inserted into the groin or arm, explains www.med.umich.edu. Angiograms, that is, the pictures obtained using live x-ray, show how blood circulates in the blood vessels of the body, and "may reveal problems with the blood flow or the blood vessels, such as narrowing or blockage or enlargement of the arteries." In modern angiography systems, each frame of the picture is stored digitally in a computer. "These x-ray `movies' can be viewed in real time as the angiography is being performed, or they can be reviewed later using recall from digital memory," says http://imaginis.com. "Digital angiography systems are capable of performing complex imaging tasks with maximum efficiency. It allows the physician and technician to augment the photographs and speed the photography process," states www.delawareeye.com.
Microlab at heart of case
Life-saving technology, you'd appreciate, but the Department officials had an objection. Because when they examined the imported goods, they found that Wipro had brought `Microlab' along with the angiography system. Microlab is not entitled for the exemption, said the Department. Microlab is "an independently operated equipment and not an accessory to the cardiovascular angiography system," said the officials. Therefore, the imported goods were confiscated under the Customs Act, and a redemption fine of Rs 5 lakh imposed, along with a penalty of Rs 2 lakh. Wipro challenged the findings of the Department, and approached the Customs, Excise and Service Tax Appellate Tribunal, South Zonal Bench, Bangalore, for relief. Rajesh Chandra Kumar argued on behalf of Wipro, while K.S. Bhat represented the taxman. Kumar contended that accessories of cardio vascular angiography system are entitled for the benefit of the exemption notification. He said that the Department had not properly gone through the technical literature, and therefore had come to the conclusion that Microlab was not an accessory of the cardiovascular angiography system. Kumar cited from the machine's technical literature thus: "Microlab's multifunction talents relay become apparent in conjunction with our best known cardio systems. It can, for example, be operated in one compact unit as an ECG at rest or as a stress test workstation." He referred to a 1999 decision, in the East India Clinical Lab case; there, the Tribunal had held that "a combilabor AS automatic day-light film processing unit is an accessory of angioscope on the ground that the angioscope will become a useless instrument unless the films it takes are studied by medical experts concerned." Likewise, the angiography system would be practically useless without Microlab, explained Kumar. "It is essential to monitor the haemodynamic status of the patients while conducting the angiography. Thus Microlab is undoubtedly an accessory to the angiography system," contended Kumar. In response, Bhat relied on the apex court's decision in the Perfect Machine Tools Co P Ltd case; there, it had been held that merely because an attachment cannot work independently is no ground for granting exemption. "An accessory is not entitled for exemption unless the same has expressly been included in the exemption notification," said Bhat. S.L. Peeran and T.K. Jayaraman, Tribunal Members, heard the arguments. "We have gone through the records of the case carefully," reads the text of the Tribunal's order dated February 2. "The main item imported by the appellants is known as cardiac vascular angiography system including digital angiography. Coronary angiography is non-invasive procedure in the diagnosis and treatment of heart diseases," noted the Tribunal. "Catheters (tubes of specific shape and size) are inserted into various chambers of the heart and its blood vessels and pressures are measured. During the procedure radiographic images (pictures taken using X-rays) are taken by injecting dye into the heart. This is known as angiography," explains the text. "Since the above procedure carries tremendous risk, it is essential to monitor the haemodynamic status of the patient throughout the case. This involves the display and recording of parameters like blood pressure, oxygen saturation, ECG, etc. For the above purpose, Microlab is used in the cathetisation laboratory," added the Tribunal.
Risks in procedure
There are risks in angiography, please note. "Some patients can have bleeding, swelling, or bruising where the catheters were inserted," alerts www.sjm.com, the site of St. Jude Medical. "Serious complications do sometimes occur. These include infection, damage to the heart and/or blood vessels, and blood clots. Death is very rare during these procedures." One gathers this from the Tribunal's order: "There are incidents where patients are to be given electric shocks defibrillation as part of managing certain emergency situations." Tribunal noted that Microlab had a socket and storage for defibrillating. "Microlab is also used to measure cardiac output (quantity of blood pumped out per minute from the heart) in the cath lab. A close reading of the functions of the Microlab reveals that the same is used while performing the procedures of catheterisation," stated the Tribunal. "Therefore, we do not have any doubt in holding that the equipment is used in conjunction with cardiovascular angiography system for monitoring the various haemodynamic parameters," ruled the Tribunal. "In these circumstances we hold that the Microlab is an accessory of the cardiovascular angiography system and is entitled for the benefit of Notification." So, to wrap, "When thy poor heart beats with outrageous beating," as in Titus Andronicus, remember, "Heart hath his hope," after all, as Shakespeare pens in a poem.
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