The Drugs Technical Advisory Board (DTAB) has recommended the prohibition of the manufacture, sale, and distribution of pain relief drug combination S(+) etodolac+paracetamol. The combination is manufactured by Emcure Pharmaceuticals and it received the DCGI nod in 2009 for the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.
Earlier also the DTAB had recommended the prohibition of the combination. However, Emcure Pharmaceuticals had availed a favourable order from the Delhi High Court against the recommendation.
In the latest DTAB meeting held on January 25, 2024, the DTAB said that the sub-committee was constituted through an office memorandum on December 15, 2022 and it evaluated the replies and clarifications presented by the firms, received through the Central Drugs Standard Control Organisation, in response to the notices issued in respect of the fixed-dose combination (FDC).
Without elaborating on the sub-committee findings, the Board concluded, “DTAB deliberated the matter and agreed for prohibiting the manufacture, sale and distribution for human use of FDC drug S(+) etodolac+ paracetamol”.
In 2018, the Central government had prohibited the FDC etodolac + paracetamol, which was manufactured by various companies in the country including Emcure’s S(+) etodolac + paracetamol combination with the reasons that the FDC may involve risk to human beings.
According to a report by Pharmabiz, the combination was one of the formulations that were prohibited based on the recommendation of a sub-committee under the chairmanship of Dr. Nilima Kshirsagar, which was formed to evaluate the 349 FDCs which were prohibited by the government in 2016 and 2017.
Following this, various manufacturers of the FDC, including Emcure, approached the Delhi High Court against the decision and the Court issued an order on January 22, 2020.
While the High Court dismissed the petitions filed by other players for etodolac +paracetamol combination finding them with no merit, it deliberated on the petition filed by Emcure and observed that the DTAB or the sub-committee could have considered and given reasons whether there is no difference between the two FDCs.
Emcure argued that “S” in its FDC stands for Chiral, which is pure form. S(+) etodolac is a pharmacologically active component of racemate etodolac. It argued that the S(+) etodolac has various advantages over etodolac.
However, DTAB in the Delhi High Court argued that there is no difference in therapeutic value of etodolac and S(+) etodolac and the claim of the company before the DTAB was not that the FDC of the petitioners is different from the FDC of etodolac+paracetamol; the claim was that it is more potent, it added.
