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TMI Blog2018 (2) TMI 1681X X X X Extracts X X X X X X X X Extracts X X X X ..... terms of the agreement is M/s Merck, USA - it is clear that these services are for delivery and consumption of an entity located outside India. Appeal allowed - decided in favor of appellant. - Service Tax Appeals No. 522-524 of 12 and 56440 of 2013 - Final Order No. 50802-50805/2018 - Dated:- 22-2-2018 - Hon ble Shri S.K. Mohanty, Member ( Judicial ) And Hon ble Shri B. Ravichandran, Member ( Technical ) S/Shri N. Venkataraman, Senior Advocate and Ms. Indu Amar, Advocate for the appellant Shri R.K. Manjhi, Authorized Representative (DR) for the respondent ORDER Per. B. Ravichandran These 4 appeals are on common dispute and are accordingly taken up together for disposal. There are two impugned orders coverin ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... etting a new drug tested in India in clinical trial. Both the appellant as well as SIRO are recognized clinical research organization. Both applied to the Drug Controller General of India (DCGI) and obtained no objection to proceed with the clinical trial in pursuance of the said agreement. In terms of these agreements with M/s Merck, USA appellant and SIRO had defined roles which complemented each other in the final conclusion of the clinical trial as per the standards and also in preparing and reporting to DCGI and coordinating with M/s Merck, USA. 4. The learned Counsel submitted that the Notification 11/2007 is clear to the effect that services provided in relation to testing and analysis of newly developed drugs on human participant ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... l coordinate clinical status in addition to conducting clinical studies. We have also perused the details of various activities undertaken by the appellant. The appellants were engaged in finalizing the testing protocol, training the staff for trial, applying and obtaining approval of DCGI, import of drug to be tested in India, monitoring the protocol, finance management, reporting adverse developments, documentation and archival of the said document of the final reporting to M/s Merck, USA and DCGI. SIRO were also involved in activities in the said clinical trial. These activities are initiation of trial sites, monitoring, trial monitoring, site management, query response and coordinate with M/s Merck, USA etc. Perusal of these details cle ..... X X X X Extracts X X X X X X X X Extracts X X X X
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