2018 (2) TMI 210 - AT - Central Excise

Tribunal denies exemption for I.V. Fluids with Schedule 'H' drugs

The Tribunal ruled in favor of the Revenue, denying the respondents' eligibility for exemption under Sl. No.56 of Notification No.6/2002-CE for ... Benefit of N/N. 6/2002-CE, dated 01.03.2002, Sl. No.56 - I.V. Fluids viz., Ofloxacin I.V. Infusion - 100 ml., Metronidazone Injection - 100 ml., Ciprofloxacin Injection - 100 ml., and Mannitol Injection - 100/350 ml - Revenue entertained a view that when the drugs manufactured by the respondents are administered intravenously, the same will not qualify for exemption in the above entry as the said exemption is available only to I.V. Fluids used for Sugar, Electrolyte or Fluid replenishment. Held that: - it is nobody's case that I.V. Fluids that are purely used for replenishment purposes are similar to I.V. Fluids used for therapeutic as well as replenishment purposes. Apparently, both are for different medical purposes and application. They are not interchangeable - in M/s Venus Remedies Ltd. Versus Commissioner of Central Excise [2011 (8) TMI 688 - PUNJAB AND HARYANA HIGH COURT], it was held that exemption shall not be available in case Schedule ‘H' drugs are added in I.V. Fluids. The impugned orders with reference to eligibility of the respondents for the exemption set aside. Appeal allowed - decided in favor of Revenue. Issues:1. Interpretation of exemption under Sl. No.56 of Notification No.6/2002-CE for I.V. Fluids used for specific purposes.2. Applicability of exemption when Schedule 'H' drugs are added to I.V. Fluids.3. Dispute regarding therapeutic value versus replenishment value of I.V. Fluids.Issue 1: Interpretation of exemption under Sl. No.56 of Notification No.6/2002-CE for I.V. Fluids used for specific purposes:The case involved a dispute over the eligibility of exemption claimed by the respondents for manufacturing I.V. Fluids under Sl. No.56 of Notification No.6/2002-CE. The Revenue argued that the exemption was only for I.V. Fluids used for Sugar, Electrolyte, or Fluid replenishment, excluding therapeutic applications. The Commissioner (Appeals) had allowed the claim based on previous Tribunal decisions. However, the Tribunal, considering the Punjab and Haryana High Court judgment, held that the therapeutic value of I.V. Fluids becomes dominant when Schedule 'H' drugs are added, making them ineligible for the exemption. The Tribunal found that the exemption was specific to the usage of I.V. Fluids for replenishment purposes only, not therapeutic applications.Issue 2: Applicability of exemption when Schedule 'H' drugs are added to I.V. Fluids:The main contention was whether the addition of Schedule 'H' drugs to I.V. Fluids affected their eligibility for exemption. The Tribunal referred to the High Court's ruling, which emphasized that the addition of such drugs changed the medicinal value of the fluids, making them unsuitable for the exemption. The High Court highlighted that once I.V. Fluids were medicated with Schedule 'H' drugs, their use for specific diseases altered their original purpose of replenishment. This change in purpose rendered them ineligible for the exemption under the notification.Issue 3: Dispute regarding therapeutic value versus replenishment value of I.V. Fluids:The case also revolved around the debate between the therapeutic and replenishment values of I.V. Fluids. The respondents argued that certain drugs were administered alongside Electrolytic I.V. Fluids, which should not disqualify them from the exemption. However, the Tribunal reiterated that the exemption was intended for I.V. Fluids used solely for Sugar, Electrolyte, or Fluid replenishment. The High Court's decision further clarified that the therapeutic value of I.V. Fluids became prominent when Schedule 'H' drugs were added, leading to a shift in their usage from replenishment to medicinal purposes. This distinction between the two types of I.V. Fluids was crucial in determining their eligibility for the exemption.In conclusion, the Tribunal upheld the Revenue's appeals, setting aside the impugned orders and denying the respondents' eligibility for the exemption under Sl. No.56 of Notification No.6/2002-CE. The judgment emphasized the importance of differentiating between I.V. Fluids used for therapeutic purposes and those intended solely for replenishment, especially when Schedule 'H' drugs were involved in the manufacturing process.