The Maharashtra Authority of Advance Ruling (AAR) has ruled that Goods and Service Tax (GST) is payable on Biotech’s Cancer Test.
The bench of D. P. Gojamgunde and Priya Jadhav have observed that Epigeneres Biotech Private Limited has not provided copies of any approval from the Indian Council for Medical Research (ICMR) with respect to acceptance of their tests for cancer detection as a valid diagnostic test for the said purpose.
The AAR stated that the cancer tests carried out by the applicant cannot be treated as a proper diagnostic test but is more in the nature of clinical research and development and as a result it does not qualify as a Health Care Service as envisaged under Notification No. 12/2017Central Tax (Rate) dated 28.6.2017.
The applicant is operationalizing the laboratory in which it uses defined standard protocols, blood-based test. The outcome of blood tests would assist in the early detection of cancer.
The applicant sought the advance ruling on the issue whether the provision of diagnostic services by the applicant would qualify for exemption from GST and consequently the proposed services would get classified under service accounting code 9993?
The AAR while denying the GST exemption held that the test claimed ot eb a diagnostic test by the applicant is still in its developmental stage and is not yet validated by the medical regulatory bodies.
Diagnosis has been described as “pre-existing set of categories agreed upon by the medical profession to designate a specific concern.” Any inconclusive research, not agreed to by the medical fraternity nor approved by the regulatory authorities in India such as the DCGI through CDSCO, the ICMR or any other regulatory body under the Drugs & Cosmetics Act, would not qualify as a Health Care Service as envisaged under the Notification No.12/2017, in order to qualify as Health Care Service, the diagnosis should be recognized and validated by the medical fraternity and the Indian regulatory authorities. It is only then that the tests carried out by the applicant would qualify as a health care service. Till that time, it remains under the realm of research and development of new technology in the field of biotechnology and medicine.
Ruling Details
Applicant Name: M/S. Epigeneres Biotech Private Limited
Date: 27/03/2025
