Case nº Ruling No. AAR/44/ST-I/27/2016 in Application No. AAR/44/ST-1/13/2015 of AAR Cases, July 12, 2016 (case In Re : Steps Therapeutics Limited Vs)

Judge:For Appellant: Shri Tarun Gulati, Kishore Kunal and Manish Rastogi, Advs. and For Respondents: Shri Ranjan Khanna, AR
President:V.S. Sirpurkar, Chairman, Shri S.S. Rana and R.S. Shukla, Members
Defense:Finance Act, 1994
Resolution Date:July 12, 2016
Issuing Organization:AAR Cases
 
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Court Information AAR Cases
Citation 2017 (49) STR 114 (AAR)
Judgment Date 12-Jul-2016
Party Details In Re : Steps Therapeutics Limited Vs 
Case No Ruling No. AAR/44/ST-I/27/2016 in Application No. AAR/44/ST-1/13/2015
Judges V.S. Sirpurkar, Chairman, Shri S.S. Rana and R.S. Shukla, Members
Advocates For Appellant: Shri Tarun Gulati, Kishore Kunal and Manish Rastogi, Advs. and For Respondents: Shri Ranjan Khanna, AR
Acts Finance Act, 1994

Ruling:

1. M/s. Steps Therapeutics Limited (hereinafter also referred to as applicant) is in the process of setting up its business of Contract Research Organization whereby, the applicant will be establishing, developing and carrying on research in basic and applied sciences in relation to all kinds of drugs, pharmaceuticals and formulations, health care and bio-technology and also to provide services to its customers in this regard ("proposed research services"). In furtherance to its business objects, the applicant proposes to conduct clinical trial of drugs provided by its customers located outside India on eligible volunteers within the applicant''s facilities which are proposed to be in India. Applicant is in the process of negotiating contracts with various customers located outside India. The agreement for the proposed research services and clinical trials to be conducted by the applicant, provides that the following heads of service will be rendered by the applicant to its customers:-

i. Clinical Pharmacology: The Service involves Bio-equivalence and Bio-availability clinical studies (studies carried out for generic drugs) which includes fasting and fed conditions, single and multiple dose in healthy subjects, drug-drug interaction, drug-food interaction, special/patient population studies. The study is proposed to be undertaken using formulations in the form of tablets, capsules, gels sprinkles, syrups, sprays, inhalers, etc.;

ii. Clinical Research: The service involves activities in nature of Project Management, Regulatory Affairs, Project Monitoring, Medical Writing, Bio-Statistics and Programming and Compliance. Each of these are discussed in detail as follows:-

(a) Project Management - Planning and integration service which includes serving as the primary resources and point of communication for sponsor/project team, undertaking study/site feasibility assessment, updating the sponsor and participation in telecom;

(b) Regulatory Affairs: Assistance in regulatory submissions at all phases of drug development and obtaining approvals from DCGI, DGFT and ICMR including approvals for conduct of clinical trials in India, for importing test drug and for exporting biological samples;

(c) Medical Writing: Assistance in preparation of investigator brochure, protocol, case report form, patient information leaflets, informed consent form, safety data reports, medical translation and study related forms and logs;

(d) Project Monitoring: 24/7 response line for medically related questions or report adverse events.

(e) Compliance: Audit of investigator sites as per protocol and other regulatory requirements like GCP compliance review, IRB/EC audits, on-site investigator audits, drug accountability reviews, database audit, study document reviews.

2. In terms of the sample Agreement, the applicant will be undertaking clinical trials of the drugs of the customers situated outside India on volunteers in India. The said volunteers will be given dosages of the drug as prescribed by the customers and medical professionals and thereafter, the applicant will be conducting screening of such volunteers wherein the volunteers are kept under observation and their blood samples are tested for identification of various parameters as required by the customers. Pursuant to the said clinical trials, the applicant will be required to report the test results through online medium to the customers. The applicant will be charging consideration from the customers on project to project basis. The above activities form part of the main activity of providing research assistance services to the customers and would not be provided in isolation. However, the activities of Bio-Statistics & Programming and Compliance services may be provided independently.

3. The present application is being filed for a definitive ruling on the following questions:

Whether the proposed activities of undertaking Clinical Research and Clinical Pharmacology by...

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