TaxTMI 
TaxTMI 
2021 (2) TMI 195
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.... in India to determine the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. 3. The applicant has sought advance ruling in respect of the following question: a. What will be the SAC applicable to the activities undertaken by M/s. Vevaan Ventures? b. Whether the exemption given under Notification No. 9/2017- Integrated Tax (Rate) dated 28.06.2017 is applicable to the applicant? c. Whether the applicant can avail input tax credit of tax paid or deemed to have been paid? d. Whether the applicant is liable to pay tax on outward services, if yes, at what rate? e. Whether the applicant is required to be registered under the Act? 3. Admissibility of the application: The application is in relation to the classification of goods and rate of tax applicable to the supplies made, the eligibility of input tax credit and also on the liability to register under the GST Act and the same is verified and found admissible and hence admitted. 4. The applicant furnishes some facts relevant to the issue: 4.1 M/s Vevaan Ventures is a Partnership Firm having its registered....
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....a care bundle approach, when individual elements are executed simultaneously and consistently, substantial improvements in outcomes occur. 4.4.3 Regarding the role of the applicant, the applicant states that they will be responsible for identification of research sites in India and on boarding of research staff comprising of Doctors, Nurses and other support staff to conduct its study. Alongside, the applicant would be responsible for purchase of the necessary medical equipment and do such other activities for carrying out the said medical research. The applicant would share updates with regards to the stages & findings of research study and shall raise periodic invoices towards the conduct of research study as agreed between the parties vide Clinical Trial Agreement and the same shall be made good in accordance with terms of the said agreement. 4.4.4 Regarding the role of Imperial College London, the applicant states that Imperial College London (legally Imperial College of Science, Technology and Medicine) is a public research university located in London. Imperial College was established in 1907 in London's scientific and cultural heartland in South Kensington, as a me....
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....by way of diagnosis or treatment or care for illness, injury, deformity, abnormality or pregnancy in any recognized system of medicines in India and includes services by way of transportation of the patient to and from a clinical establishment, but does not include hair transplant or cosmetic or plastic surgery, except when undertaken to restore or to reconstruct anatomy or functions of body affected due to congenital defects, developmental abnormalities, injury or trauma. 5.6 The applicant stated that the proposed research program shall be carried out to conduct in-depth studies on pregnant women in India and examine if "Epilepsy" caused by brain related injury occurring at the time of childbirth can be prevented. Accordingly, the research study aims to diagnose certain abnormalities caused during childbirth and thus the services provided by the entity squarely fall under the purview of the term health care services as defined supra. VIRTUAL HEARING: / PROCEEDINGS HELD ON 08-10-2020 6. Sri Sukruth N Segu and Sri Ashray Hosakote Chartered Accountants and Duly Authorized Representatives alongwith the applicant appeared for virtual hearing proceedings on 8th October 2020 bef....
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....y the applicant is being conducted in three Government Medical Colleges in Calicut, Bengaluru and Hubballi and is in partnership with the National Health Mission of the Government of India. It has been approved by all relevant ethics committees and the Indian Council of Medical Research. The Study is funded by the UK Government (National Institute for Health Research) at the request of WHO, for reducing epilepsy in India. It is sponsored by Imperial College, London and is entirely for non-profit and for the benefit of the poor people in India. If the study shows the care bundle intervention is effective, then it would form the basis for Health Policy in India. 12. Regarding the role of the applicant, the applicant is infact doing the entire research in India, i.e. identifying the hospitals that are to be the research sites, on-boarding of the research staff, namely Doctors, Nurses and other support staff to use the intervention methods. The applicant is undertaking the activities for updation of the knowledge of the medical staff by conducting conclaves, meetings, symposiums, gatherings amongst others. Later on the applicant would provide the tablets and devices which are used i....
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.... iii. to recruit new patients for study iv. to ensure research specific investigations are undertakes as per the protocol v. to provide ongoing information, education and support to patients and their significant others regarding clinical studies vi. to maintain accurate documentation of patient events in medical notes vii. to co-ordinate MRI scans and EEG of babies viii. to collect and store blood and other tissue samples from babies recruited into various research projects, as directed by the principal investigator 16. The applicant is also entering into tripartite agreement with the principal investigator and the sponsor. The Chief Investigator is at the Sponsor and the project shall be performed by and under the direction and supervision of the Chief Investigator 16.1 As per the agreement, the scope of work for the applicant is as under: a) Enter into agreements/ contracts with the trial sites identified by the sponsor for enabling the conduct of research study Provide medical and co-investigators. b) equipment and other related apparatus to enable the conduct of the research c) Engage a team of rese....
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.... fully acquainted with the protocol and all information and documents provided by the sponsor concerning the research study c) Immediately notify the sponsor and the institution of all necessary amendments to the protocol or any deviations from the protocol, which are imperative to avoid immediate danger to the subjects, and immediately execute necessary precautions for the protection of the subjects d) Ensure that all the persons assisting in the trial, and if necessary, also others engaging in the treatment of the subjects have been properly informed of the protocol, investigational products and their obligations and duties relating to the trial e) Immediately report to the sponsor and the institution all serious adverse events apart from the events, which according to the protocol or any other document, such as Investigator's Brochure, do not require immediate reporting, and also to follow the protocol with respect to the reporting of adverse events f) Ensure accuracy, completeness, reliability, and timeliness of the information submitted to the sponsor on the case report forms and all required reports, including those in electronic format....
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....sacting on principal to principal basis and shall have no authority to assume or create any obligation whatsoever express or implied, in the name of the other Party or to bind the other Party in any way or manner. Nothing in the agreement shall be deemed to constitute either party a partner, agent, joint venture or legal representative of the other party, or to create any fiduciary relationship between the parties. 16.6 It is clear from the tripartite agreement, that the applicant is entering into contractors or agreements with the trial sits, provide equipments to enable the conduct of research, engage research staff, manage the safe conduct of research and liaise with the investigators. This clearly states that the applicant is managing the research in India and in not per-se involved in the research. It is a support activity and the principal investigators conducting the research are the actual persons doing research and providing the data to the sponsor. 17. The sample consultant agreement submitted by the applicant is examined and found that the consultant hired are rendering services to the applicant and the manner in which the consultant chooses to complete the service....
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....ts (and their significant others) regarding clinical studies (g) to maintain accurate documentation of patient events in nursing / medical notes. (h) monitor intra-partum care and treatment to mothers and changes to treatment as required by the protocol. (i) Record and report adverse events which occur while patient is in the clinical study to the study coordinator or Principal Investigator and relevant local personnel / regulatory authorities (j) Work closely with other research staff (including neonatal research nurses and data entry personnel) and provide adequate support in times of need. 17.3 From the above, it is seen that the outsourced consultants by the applicant are also engaged in providing support services and not actual research activities. 18. The opinion of the applicant that their activity would be covered under "health care services" is examined and found that the term "health care services" is defined in Notification No.09/2017 - Integrated Tax (Rate) dated 28.06.2017 in clause (zg) of para 2 and the same reads as under: "(zg) "health care services" means any services by way of diagnosis or treatment or care for i....
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....or facilitates the supply of goods or services or both, or securities, between two or more persons, but does not include a person who supplies such goods or services or both or securities on his own account;" The applicant is involved in the arranging and facilitation of the supply of research services by the principal investigator to the Imperial College London and he is not covered under the exclusion clause as he is not supplying "such" research services on his own account, therefore the applicant is covered under the definition of an "intermediary" under section 2(13) of the IGST Act, 2017. 19.3 Section 13 (8) (b) of the IGST Act, 2017 specifies the place of supply in case of intermediary services as that of the location of the supplier and hence the place of supply is the location of the applicant and since this is in India, the transaction between the applicant and the Imperial College London would not be an export of services under section 2(6) of the IGST Act, 2017. 20. The activity of the applicant is squarely covered under the entry no.23(ii) of Notification No.11/2017- Central Tax (Rate) dated 28.06.2017 and is liable to tax at 9% CGST and similarly liable to ta....