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    <title>2019 (11) TMI 1511 - CESTAT MUMBAI</title>
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    <description>Exemption from service tax for clinical trial services was available where a clinical research organisation conducted trials under approved protocols and the trials were registered with the Clinical Trial Registry of India. The relevant rules required permissions and registration for clinical trials, but did not separately define clinical research organisation or clearly require a fresh general approval for each trial. On that basis, the clinical trial activity fell within the exemption notification and was not taxable under section 65(105)(zzh) of the Finance Act, 1994. Once that exemption was accepted and the remaining tax liability had been discharged, the basis for penalty under section 78 also fell away, so the penalty was not sustainable.</description>
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      <description>Exemption from service tax for clinical trial services was available where a clinical research organisation conducted trials under approved protocols and the trials were registered with the Clinical Trial Registry of India. The relevant rules required permissions and registration for clinical trials, but did not separately define clinical research organisation or clearly require a fresh general approval for each trial. On that basis, the clinical trial activity fell within the exemption notification and was not taxable under section 65(105)(zzh) of the Finance Act, 1994. Once that exemption was accepted and the remaining tax liability had been discharged, the basis for penalty under section 78 also fell away, so the penalty was not sustainable.</description>
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