The Department of Pharmaceuticals (DoP) has directed the NPPA to re-fix the ceiling price of “Methotrexate tablets 2.5 mg, 7.5 mg and 10 mg” by considering only 8 formulations with SKU-wise MAT of more than 1% market share” as the DoP is of the view that there are 8 products with SKU wise MAT of more than 1% market share, which should have been considered instead of company wise MAT considered by NPPA.
The DoP's directive in this regard came while reviewing a review application filed by IPCA Laboratories against price fixation of methotrexate tablets 2.5mg., 7.5mg and 10mg (company’s brand Folitrax) by the NPPA through its order S.O. No. 2193(E) dated 23/06/2016 issued under DPCO 2013.
The IPCA Laboratories in its review petition contended that the NPPA has considered old and discontinued retail packs which appear in Pharmatrac. NPPA has considered retail packs whose market share is less than 1% which is against laid down policy. Zydus Cadila is shown as having multiple retail packs and these inaccuracies need to be verified. Zydus Cadila is marketing 4’s pack only. And the accuracy of Pharmatrac is questionable and NPPA has unilaterally switched over to this source without consulting anybody in the industry and even ignoring what was laid down in the policy.
In reply, the NPPA commented that shifting of outsource agency IMS to Pharmatrac & consideration of Pharmatrac data has been done correctly by NPPA as per para 9(2) of DPCO, 2013.
During examination of the case, the DoP noted that the petitioner contended that NPPA has considered old and discontinued retail packs which appear in Pharmatrac. Zydus Cadila is shown multiple retail packs and these inaccuracies need to be verified since Zydus Cadila is marketing 4’s pack only. The petitioner company did not submit any documentary proof in support of its claim. Hence, the claim of the petitioner company cannot be accepted. As per Para 4(i) of DPCO, 2013, sum of prices to retailer of all the brands and generic versions of the medicine having market share more than or equal to one per cent of the total market turnover on the basis of moving annual turnover of that medicine is to be considered while calculating the ceiling price of a scheduled formulation. It is perused from the calculation sheet that there are 8 products with SKU wise MAT of more than 1% market share, which should have been considered instead of company wise MAT considered by NPPA. Therefore, NPPA may be directed to re-fix the ceiling price of formulation “Methotrexate tablets 2.5 mg, 7.5 mg and 10 mg” considering only 8 formulations instead of 9 formulations considered by NPPA.