New Delhi: The Drugs Technical Advisory Board (DTAB) of the Union health ministry has once again recommended prohibiting the manufacture, sale and distribution of pain relief drug combination S(+) etodolac+paracetamol, after considering a sub-committee report.
The DTAB has earlier recommended prohibition of the combination, against which its manufacturer Emcure Pharmaceuticals availed a favourable order from the Delhi High Court.
Following the Court order, the DTAB also recommended formation of the sub-committee under the chairmanship of Dr. Lalit Kumar Gupta, director, Prof., Department of Pharmacology, LCMH Hospital, New Delhi and one expert each from clinical pharmacology, orthopaedics and medicine. The sub-committee was recommended to co-opt subject experts as and when required.
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 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”.
As reported earlier, the Central Government prohibited the FDC etodolac + paracetamol, which was manufactured by various companies in the country, and Emcure’s S(+) etodolac + paracetamol combination, through an order on September 7, 2018, with the reasons that the FDC may involve risk to human beings. The combination was one of the formulations which 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.
The sub-committee recommended 343 FDCs be prohibited, and of the remaining, three need to be restricted for specific indications and three others to be restricted to specific quantities/strengths of ingredients and for specific indications.
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, that is pure form. S(+) etodolac is a pharmacologically active component of racemate etodolac. The anti-inflammatory, analgesic and antipyretic activities of S (+) Etodolac have been observed to be due to inhibition of cyclooxygenase-2 (COX-2) resulting in inhibition of prostaglandin synthesis. It argued that the S(+) etodolac has various advantages over etodolac.
The Court observed that it cannot, in expertise of its power of Writ Jurisdiction, examine this aspect as it is no expert on the same.
The sub-committee not having considered the clinical trial conducted by the company for the FDC, its report would clearly have ignored relevant material, thereby making it susceptible to challenge, observed the Court.
The DTAB sub-committee decision on September 7, 2018, which was challenged by the companies, said that FDC of etodolac 300mg + paracetamol 500mg film coated tablet was approved by the Drug Controller General (India) on October 20, 2009 for the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
The FDC of S(+) etodolac 150/200/300mg +paracetamol 500/500/500mg Tablets was approved by DCGI on November 25, 2009 for the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
DTAB in the Delhi High Court argued that the isomers having the same therapeutic value in terms of safety and efficacy are included in the Notification and there is no difference in therapeutic value of etodolac and S(+) etodolac, 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.
