UP AAR: F-18 Drugs Use for Cancer Diagnosis Are Subject to 18% GST

18% GST is applicable on F-18 drugs used for cancer diagnosis the Uttar Pradesh Authority of Advance Ruling (AAR) stated.

Amit Kumar and Harilal Prajapati’s bench noted that F18 constitutes a radioisotope, while fluorodeoxyglucose (18F-FDG) represents a compound. Despite meeting the criteria outlined in Chapter 30 as a diagnostic reagent intended for patient administration, their radioactive nature and association with the radioisotope 18F warrant their categorization solely under heading 2844.

The applicant specializes in producing groundbreaking drugs such as 18F-fluorodeoxyglucose, 18F PSMA, 18F DOPA, and numerous other radioactive compounds labelled with F 18. These F18 compounds, utilized predominantly for cancer diagnosis but also in cardiology and neurology, are radioactive isotopes functioning as diagnostic reagents.

The applicant’s stance asserts that F18 should fall under chapter heading 3006 of the HSN, attracting a 12% GST rate according to entry No. 65 of Schedule II of Notification No. 01/2017-CT (Rate) dated June 28, 2017, in conjunction with the corresponding rate notification issued under the UPGST Act, 2017.

The applicant sought an advance ruling to determine whether F-18 products should be classified under HSN 30063000, attracting a 12% GST rate as specified in entry No. 65 of Schedule II of Notification No. 01/2017-CT (Rate) dated June 28, 2017, under the CGST Act, 2017, in alignment with the relevant rate notification issued under the UPGST Act, 2017.

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The appellant argues that the product under consideration, serving as diagnostic reagents for patient administration, should fall within the classification of heading 3006: “Opacifying preparations for X-ray examinations; diagnostic reagents designed for patient administration.”

However, the AAR dismissed the applicant’s classification under HSN 30063000 and enforced an 18% GST rate under HSN 2844. This ruling carries significant weight for enterprises handling radioactive compounds, establishing a precedent for comparable situations. The clarity offered by the AAR establishes a uniform method for categorizing such products within the GST framework.