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The Subcommittee noted that FDC of Etodolac 300mg + Paracetamol 500mg film coated tablet is approved by DCGI on 20.10.2009 for the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. Also, Subcommittee noted that FDC of S (+) Etodolac 150/200/300mg + Paracetamol 500/500/500mg Tablets is approved by DCGI on 25.11.2009 for the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. The FDC of Etodolac + Paracetamol was deliberated by NDAC (Analgesics, Anesthetics & Rheumatology) in its meeting held on 19.02.2014. The NDAC commented as under:

10. The learned counsels for the petitioners submit that the Impugned Notification does not comply with the directions issued by the Supreme Court in Pfizer Limited and Others (Supra). They submit that the reason for discrediting the „Clinical Study‟ (Pareek A et al. Efficacy and Safety of Etodolac-Paracetamol Fixed Dose Combination in Patients With Knee Osteoarthritis Flare-up: A Randomized, Double-blind Comparative Evaluation. Clin J Pain 2010;26:561-566) is ill founded inasmuch as the Sub-Committee failed to note that by Order dated 23.09.2011, the Directorate General of Health Services (DGHS) had limited the content of Paracetamol to not more than 325 mg per tablet in combination products. Therefore, merely because the Clinical Study was by using Paracetamol of 500 mg, the same could not have been discarded.

32. The petitioners further claim that the DGHS vide its communication dated 18.09.2009 granted permission to the petitioner no. 1 for conducting Phase III clinical trial for the said FDC using comparator drug of Diclofenac Sodium 50 mg +Paracetamol Tablets. It is further claimed that the petitioner no. 1 carried out such clinical trial and submitted its report dated November, 2009. The said clinical trial concluded as under:-

"This multi-centric, randomized, clinical trial to assess and compare the efficacy and safety of the fixed dose combination of S-etodolac and Paracetamol (test group) versus the fixed dose combination of Diclofenac and Paracetamol (comparator group) showed that both the products provide similar analgesic efficacy, with better tolerability and lesser adverse events with the fixed dose combination of S-etodolac and Paracetamol. This study confirms the safe and effective use of fixed dose combination of S-etodolac and Paracetamol in Indian patients."

40. I have considered the submissions made by the learned counsels for the parties. A reading of the recommendations of DTAB/Sub-

WP(C) Nos.10098/2018, 10114/2018, 10919/2018 11067/2018 & 11392/2018 Page 18 Committee would show that while the Sub-Committee noted that the FDC of Etodolac + Paracetamol had been approved by DCGI on 20.10.2009 and the FDC of S (+) Etodolac + Paracetamol had been approved on 25.11.2009, the sub-committee, however, made no recommendation for FDC of S (+) Etodolac + Paracetamol. It is further evident that the Sub-Committee considered only the Clinical Study (Pareek A et al) and not the clinical trial of the petitioners conducted in the year 2009. The Sub-Committee also did not consider the effect of Diclofenac + Paracetamol, which was a comparator drug for the clinical trial for the FDC in question, to have been approved by the DTAB.