GST Classification of Radiopharmaceuticals Like FDG
The Maharashtra Authority for Advance Ruling decided that radioactive medical products like FDG must be classified under Chapter 28, not Chapter 30.
- Ruling
- NO.GST-ARA-02/2017/B- 06 Mumbai, dt. 21/02/2018
- Dated
- 21 Feb 2018
- Authority
- Authority for Advance Ruling
This page was written by Patron Accounting’s AI from the official release and reviewed before publishing. It explains the document in plain language. It is not the document itself. Where this page and the original differ, the original governs.
The short version
- Nuclear Healthcare Limited asked if FDG is a diagnostic reagent under Chapter 30.
- The Authority ruled FDG is a radioactive compound under Chapter 28.
- The Authority refused to give a general ruling on all pharmaceutical chemicals.
In short
The company asked the Maharashtra Authority for Advance Ruling (AAR) whether their medical imaging product, Fludeoxyglucose (FDG), should be taxed as a pharmaceutical under Chapter 30 or as a radioactive compound under Chapter 28. The tax authority looked at international trade rules and decided that because the product contains radioactive isotopes, it must be classified under Chapter 28.
What has changed
How it worked before
Businesses often assumed that because a product is used for medical diagnosis, it should automatically be classified as a pharmaceutical under Chapter 30.
What has changed
The ruling clarifies that specific rules for radioactive materials override general rules for pharmaceuticals. In practice, this means businesses manufacturing similar radioactive diagnostic agents must use the Chapter 28 classification, which may carry different tax implications than Chapter 30.
Who this affects
Manufacturers and distributors of radiopharmaceuticals or radioactive medical diagnostic agents.
An example
Imagine a company producing a different radioactive tracer for PET scans. They might want to classify it under Chapter 30 to match other medical supplies. Based on this ruling, they should expect that their tax officer will likely require them to use Chapter 28 instead, as the radioactive nature of the product takes priority.
What you should do
If you sell similar products, review your current classification against this ruling. Remember that an Advance Ruling only binds the company that asked and its specific tax office; it is not a law that applies to your business automatically.
If you do nothing
If you classify your goods incorrectly, your tax officer may issue a notice for tax evasion or misclassification. You could be forced to pay the difference in tax, along with interest and potential penalties for incorrect filings.
The terms explained
- Radiopharmaceutical
- A radioactive drug used in medicine for the diagnosis or treatment of diseases.
- Chapter 28
- A section of the tax tariff schedule that covers inorganic chemicals and radioactive elements.
- Chapter 30
- A section of the tax tariff schedule that covers pharmaceutical products.
The ruling in detail
Authority for Advance Ruling
Nueclear Healthcare Limited
NO.GST-ARA-02/2017/B- 06 Mumbai, dt. 21/02/2018 · Maharashtra
Questions before the authority
- Whether the product 'Fludeoxyglucose' or 'FDG' can be classifiable under Chapter 3006 3000 of the Central Excise Tariff Act, 1985?
- Whether chemicals used as pharmaceuticals that are inorganic or/ and of organic nature shall merit classification only under Chapter 28 & 29 and not under Chapter 30 which has been specifically carved out for chemical pharmaceuticals by makers of law?
Facts
The applicant manufactures Fludeoxyglucose (18F-FDG), a radiopharmaceutical used in medical imaging (PET scans). They sought an advance ruling on the correct classification of this product, contending it should be classified as a diagnostic reagent under Chapter 30. The applicant argued that as a pharmaceutical, it should fall under Chapter 30 rather than Chapter 28, which covers radioactive elements and isotopes.
Ruling
| Question | What the authority ruled |
|---|---|
| Classification of FDG | Not Chapter 3006 3000 The product is classified under Chapter 28 |
| General question on pharmaceutical classification | Not entertained Question was too general for an advance ruling |
The Authority ruled that the product is not classifiable under Chapter 3006 3000. Regarding the second question, the Authority held that it was of a general nature and could not be entertained under section 98 of the GST Act.
Reasoning
The Authority relied on the HSN Explanatory Notes, specifically General Note 1 of Section VI, which mandates that all radioactive chemical elements and isotopes, and compounds thereof, are classified under heading 28.44, even if they could fall under other headings. Since 18F-FDG is a compound of the radioisotope 18F, it must be classified under heading 28.44. The Authority determined that the specific provisions for radioactive materials override the general classification for pharmaceutical goods under Chapter 30. Consequently, the applicant's contention for classification under Chapter 30 was rejected.
Provisions relied on
- Section 97 of the Central Goods and Services Tax Act, 2017
- Section 98 of the Central Goods and Services Tax Act, 2017
- Central Excise Tariff Act, 1985
- General Note 1 of Section VI of the HSN
For the practitioner
This ruling confirms that radiopharmaceuticals containing radioactive isotopes are to be classified under **Chapter 28** as radioactive compounds, rather than as diagnostic reagents under Chapter 30. It serves as a warning that specific tariff notes for radioactive materials take precedence over general pharmaceutical classifications. Practitioners should note that the Authority refused to provide a broad ruling on the classification of all pharmaceutical chemicals, limiting the decision to the specific product in question.
Source
This is a summary prepared from the published order, which is a scanned document. It is a reading aid and not the authority: where the two differ, the order governs. Verify every provision against the original before relying on it.
Original order: https://www.gstcouncil.gov.in/sites/default/files/AAR/maharashtra_gst-ara-02_2017_b-02_dt_21.02.18.pdf
Legibility of the scan, as read: high.
Prepared 12-10-2026.
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