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TMI Blog2021 (2) TMI 195X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 office in Bengaluru. The firm has not obtained registration under the GST Acts. ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... tly, 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 merger of the Royal College of Science, the City and Guilds College and the Royal School of Mine ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... em 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 before this authority and they reiterated the contentions made in the application and also explained the process in detail. FIND ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 in the research studies to the trained personnel and collect the data. 13. The applicant would be purchasing necessary equipments used in the research and do such ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 research staff for managing and assisting principal investigator in all aspects of the study related research work, including EEG and MRI of the recruited infants d) Ensure that the trial shall be conducted under safe conditions e) Undertake follow up assessments of the babies recruited to the study f) Monitor ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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, and deliver the case report forms and other required reports to the sponsor. g) Take care of the registration and notification of information necessary for the invoicing to the financial administration of the institution at agreed intervals; and h) Act in co-operation with the sponsor and the institution relating to monitoring visits and audits i) Ensure that all subjects have given proper written informed consent to their participation i ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... icant 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 services is in the sole discretion and control of the consultant. The consultant's obligations shall be conditioned upon receiving such information and co-operation from the applicant as may be reasonably necessary to perform the services. It is also made clear that the agreement would not constitute an employer-employee relationship and it would be the intent of the applicant and the consultant that the consultant at all times be an independent contractor. It is also made clear that ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e 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 illness, injury, deformity, abnormality or pregnancy in any recognised 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:" The services provided by the applicant, as explained earlier is not in connection with the diagnosis or treatment or care for illness and is related to support services for research and ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 tax at 9% KGST, in case the transaction is a intra-State supply. Since the services provided by the applicant is not exempt, the applicant is eligible to claim and avail input tax credit in terms of section 16 of the CGST Act, 2017 and section 16 of the KGST Act, 2017. 21. Since the applicant is involved in intra-State supply of services, as the location of the supplier and the place of supply is the same state, the applicant is liable to register as per the terms of section 22 of the CGST Act, 2017. 22. In view of the foregoing, we rule as follows RULING 1. The activities undertaken by the applicant is covered under SAC 998599. 2. The exemption given under Notification No. ..... X X X X Extracts X X X X X X X X Extracts X X X X
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