After more than four years of being barred from exiting the market, GSK has finally been granted permission to discontinue the product.
This came after the authorities deliberated on the Form-IV intimation by GlaxoSmithkline Pharmaceutical Limited (GSK) for discontinuation of the scheduled formulation, Grisovin FP 250mg Tablet containing Griseofulvin, at the 138th Meeting of Authority under DPCO, 2013 held on 30.10.2025.
The Authority deliberated upon the matter in detail and noted that GlaxoSmithKline Pharmaceuticals had requested the discontinuation of their scheduled formulation "Grisovin FP 250mg" containing "Griseofulvin" in January 2021 due to the closure of its overseas API supplier.
The matter was examined in the Standing Committees' meetings constituted to discuss discontinuation cases.
In line with the recommendation of the Committee, direction was issued to the company to continue production for one year under para 21(2) of DPC0, 2013, i.e., up to July 2022, and identify an alternative API source, and was later directed to expedite the resumption of supplies after seeking an extended timeline.
Based on the recommendation of the Standing Committee, directions were issued by the Authority under Para 3 of DPCO, 2013, from time to time, and currently the same is in force till 31.05.2026.
Paragraph 3 of the Drugs (Prices Control) Order, 2013, grants the government the power to issue directions to manufacturers of active pharmaceutical ingredients (APIs) or formulations to increase production and regulate their sale, particularly during emergencies or for public interest. The government can also direct manufacturers to sell these drugs to specific other manufacturers or agencies and can collect necessary information to enforce these directions.
Griseofulvin is an antifungal agent used to treat a variety of superficial tinea infections and fungal infections of the fingernails and toes.
The Authority further noted that the company, vide its letter dated 24.07.2025, requested for revocation of the direction issued under Para-3 of DPCO, 2013 on the grounds of a major fire at its Indian contract manufacturing site, market shift toward Terbinafine and Itraconazole, a sharp decline in demand for the 250 mg tablet, etc.
The Authority deliberated upon the matter in detail and noted that GlaxoSmithKline Pharmaceuticals Limited (GSK) has a market share of 0.02% along with a sufficient number of market players for the subject scheduled formulation based on the July 2025 market-based data.
It was further observed that no complaints regarding shortages have been reported since 2021.
In view of the above, the Authority, after detailed deliberation, decided "to revoke the directions issued under Paragraph 3 of the DPCO, 2013."
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