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2019 (11) TMI 1511 - CESTAT MUMBAIValuation - enhancement of taxable value - N/N. 11/2007-ST dated 1st March 2007 - mandates of rule 122 DAB of Drugs and Cosmetics Rules, 1945 have not been complied with - penalty - HELD THAT:- The ‘clinical research organization’ is a generic description for agencies that undertake clinical trial of new drugs. Also, nothing is found on record that a general permission of the Drugs Controller General of India is mandated for eligibility to benefit from the exemption 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 threshold exemption as permitted in notification no. 6/2005-ST dated 1st March 2005 - the penalty imposed under section 78 of Finance Act, 1994 will not sustain. Appeal allowed - decided in favor of appellant.
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