9911796707
TMI Blog2019 (11) TMI 1511X X X X Extracts X X X X X X X X Extracts X X X X ..... n notification. It is admitted in the impugned order that the appellant herein has demonstrated that each tripartite agreement contains the approval granted for clinical trial and it is also contended by Learned Counsel that appropriate entries have been made in the Clinical Trial Registry of India. There is no evidence to controvert either of these claims. The clinical trials conducted by the appellant are in conformity with the conditions prescribed in the exemption notification and, hence, eligible for exclusion from tax under section 65(105)(zzh) of Finance Act, 1994. The appellant has discharged tax liability under the other heads confirmed in the notice. It is contended by Learned Counsel that the appellant is entitled to the threshol ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... proposed recovery as provider of other services. 2. Learned Counsel for the appellant submits that they are eligible for exemption, afforded by notification no. 11/2007-ST dated 1st March 2007, as a duly approved 'clinical research organization' which had been wrongly discarded by adjudicating authority with the finding that the Drug Controller General of India had not granted them approval and, thereby, not being in conformity with the definition in rule 122 DAB of Drugs and Cosmetics Rules, 1945. Learned Counsel refers to the tripartite clinical trial agreement, with the principal investigator and the pharmaceutical company concerned, which carries the 'protocol number' approved by Drug Controller General of India. It is contended that ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... son, by a technical testing and analysis agency, in relation to technical testing and analysis;', describing the scope of the taxable service, that exemption applies to such 'technical testing and analysis agency' which is a 'clinical research organization' that has been approved by the Drugs Controller General of India for conducting clinical trials in relation to testing and analysis of newly developed drugs on human participants. On perusal of the Drugs and Cosmetics Rules, 1945, it is seen that clinical trials are to be conducted only under permission accorded by the 'Licensing Authority', as defined in rule 21(b) of those Rules, under authority of rule 122 DAC of Drugs and Cosmetics Rules, 1945 and subject to the conditions specified ..... X X X X Extracts X X X X X X X X Extracts X X X X
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