2018 (7) TMI 275

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....l matrix is that M/s Diabetes Thyroid Hormone Research Institute Pvt. Ltd. (DTHR) is performing clinical trial to new drugs for various manufacturing companies (sponsors). The said activity was opined to be covered under the category of technical testing and analysis services as defined under Section 65(106) of the Finance Act, 1994. However, vide Notification No. 11/2007 ST dated 01.03.2007 and a subsequent Notification No. 25/2012 ST dated 20.06.2012, such services are exempted from Service Tax on the services provided or to be provided by the technical research organization approved to conduct clinical trials by the Drug Controller General of India. On the basis of various contracts of the respondent herein, the Department formed an opin....

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....r General of India in a prescribed format, giving detail of the site, i.e., place / hospital / organization, where the trial will be conducted on the patient along with the name of the investigator and the principal investigator and the guidelines permit the existence of such organizations who manage the whole or some of the process of drug trial for a sponsor to be known as Clinical Research Organization (CRO). 3. It is impressed upon that from the respondent's own documents respondents are mentioned to be the trial site and director thereof is mentioned as the investigator or the principal investigator. Thus, their own documents falsify them to be a CRO. The same has miserably been ignored by the adjudicating authority. The order, ther....

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....2012. Perusal of both these Notifications makes it a mandate that the exemption is for such technical testing and analysis service as are provided or 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. (ii) The CRO is defined in Clinical Practice Guidelines, as an organization to which the sponsor may transfer or delegate one or all of the task duties and / or applications regarding a clinical study. All such contractual transfers of applications should have defined in writing. A CRO is a scientific body, commercial, academic or otherwise. The guid....