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TMI Blog2018 (7) TMI 275X X X X Extracts X X X X X X X X Extracts X X X X ..... to be provided by a Clinical Research Organisation approved to clinical trials by the Drug Controller General of India. Thus, it becomes clear that the claimant of exemption of this Notification should be a Clinical Research Organisation. The Commissioner has held the respondent as a CRO despite the apparent fact that as per the mandatory contracts for the purpose to be entered into by the sponsor, the respondents are mentioned as trial sites. Not only this, in addition thereto, the CRO is also named in the contract itself, i.e., J.S. Icon Clinical Research India Ltd. Once two different entities are apparent from the contract itself, distinguishing the respondent to be called as mere trial site with someone else as the CRO and the exempt ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e, in as such, their activity is not exempted vide the said Notification. Resultantly, Show Cause Notice dated 04.10.2013 was served upon the respondents which was adjudicated vide the order under challenge, thereby dropping the entire levy of the said Show Cause Notice. 2. We have heard Shri Sanjay Jain for the appellant and Shri Somesh Arora for the respondent. It is submitted on behalf of the Department that the Notifications, relying whereupon, the respondent was obtaining benefit of exemption, is actually not applicable to the respondent, it not being a Clinical Research Organization (CRO), irrespective the activity of clinical trial as done by respondent is the one for technical testing and analysis services as mentioned in Section ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... g these arguments, it is submitted on behalf of the Respondent that the appellant is a drug manufacturing company who takes approval from the licensing authority and being the sponsor, delegate the functioning of clinical research to any site, duly approved for the purpose. The approval comes from the Drug Controller only in favour of anyone who is conducting trial, because without the said approval, even the trial sites and the investigators cannot conduct the test. Hence such approved trial sites, when conduct such clinical testings, they are no less than a CRO and as such, are entitled for the exemption under the above said Notifications. Otherwise also, the appellants are the Contract Research Organisations, duly approved. The adjudicat ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... that CRO, trial site, sponsor and investigators are the distinct entities. It is mandatory for even the trial site to obtain an approval from a Drug Controller of India in case of conducting such clinical trials as a question. (iii) The adjudicating authority, while appreciating the set guidelines, has observed that clinical research organization is a social unit of people like sponsor, principal investigator, investigator, volunteers, trial sites, data analyst, etc., which is meant to pursue a goal with different assigned roles, responsibilities and authority to carry our different tasks when all these are acquired together having sole objective to carry out clinical research. It has also been emphasized by the adjudicating authority it ..... X X X X Extracts X X X X X X X X Extracts X X X X
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