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Gene therapy exempted from GST-Notification issued!

CBIC has issued Notification No. 02/2025 - Central Tax (Rate) on 16^th January 2025 exempting GST on Gene Therapy. Gene therapy is a technique that modifies a person's genes to treat or cure disease. This therapy is a critical treatment option for various life-threatening diseases.

Let’s understand the change!

Notification No. 02/2025 - Central Tax (Rate) dated 16.01.2025

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MINISTRY OF FINANCE

DEPARTMENT OF REVENUE

Date: 16.01.2025

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Notification No. 02/2025 - Central Tax (Rate)

G.S.R. 53(E).- In exercise of the powers conferred by sub-section (1) of section 11 of the Central Goods and Services Tax Act, 2017 (12 of 2017), the Central Government, on being satisfied that it is necessary in the public interest so to do, on the recommendations of the Council, hereby makes the following further amendments in the notification of the Government of India, Ministry of Finance (Department of Revenue), No. 2/2017-Central Tax (Rate), published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), vide number G.S.R. 674(E), dated the 28th June, 2017, namely:-

In the said notification, -

(a) In the Schedule, after S. No. 105 and the entries relating thereto, the following S. No. and entries shall be inserted, namely: -

(b) In the Explanation, for clause (ii) and the proviso appended to it, the following clause shall be substituted, namely:-

"(ii) The expression 'pre-packaged and labelled' means all commodities that are intended for retail sale and containing not more than 25 kg or 25 litres, which are 'pre-packed' as defined in clause (l) of section 2 of the Legal Metrology Act, 2009 (1 of 2010) where, the package in which the commodity is pre-packed or a label securely affixed thereto is required to bear the declarations under the provisions of the Legal Metrology Act, 2009 (1 of 2010) and the rules made thereunder.".

2. This notification shall come into force with immediate effect.

[F. No. 190354/2/2025-TRU]

AMREETA TITUS, Dy. Secy.

Note:- The principal notification No. 2/2017-Central Tax (Rate), dated the 28th June 2017, was published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), vide number G.S.R. 674(E), dated the 28^th June 2017, and was last amended vide notification No. 3/2024 - Central Tax (Rate), dated the 12th July 2024, published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i) vide number G.S.R. 399(E), dated the 12th July, 2024.

Key Highlights

Introduction of Gene Therapy in GST Schedule: The notification inserts a new entry for Gene Therapy under the GST schedule, classifying it as fully exempt w.e.f. 16.01.2025.
Clarification on Pre-Packaged Goods: The definition of 'pre-packaged and labelled' goods has been amended. The new definition is as follows:

“The expression 'pre-packaged and labelled' means all commodities that are intended for retail sale and containing not more than 25 kg or 25 liters, which are 'pre-packed' as defined in clause (l) of section 2 of the Legal Metrology Act, 2009 (1 of 2010) where, the package in which the commodity is pre-packed or a label securely affixed thereto is required to bear the declarations under the provisions of the Legal Metrology Act, 2009 (1 of 2010) and the rules made thereunder.”

Conclusion

The recent amendments under Notification No. 02/2025 - Central Tax (Rate) highlight the government's commitment to refining the GST framework in line with evolving sectors and public health priorities. The inclusion of gene therapy under the GST schedule and the clarification on pre-packaged goods bring much-needed precision to these areas.

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