The Department of Pharmaceuticals (DoP) has directed the National Pharmaceutical Pricing Authority (NPPA) to re-fix the ceiling price of Ranitidine 25mg/ml. The DoP's order in this regard came after examining a review application filed by J.B. Chemicals & Pharmaceuticals Limited against price fixation of Ranitidine Injection - 25 mg/ml by the NPPA vide its order No. S.O. 3431(E), dated 10.11.2016 issued under DPCO 2013.
In its review petition, the petitioner contended that the ceiling price notified for formulation Ranitidine injection - 25MG/ML, as shared in NPPA’s worksheet for S.O. 3431 (E) dated 10th October, 2016, fails to mention the aforesaid formulation pack namely “Rantac injection 5 x 2ML”. It further contended that JBCPL is a major manufacturer of the scheduled formulation Ranitidine injection - 25MG/ML having Moving Annual Turnover (MAT) of INR.8.8 crores which would be over 30% of the market as NPPA worksheet only mentions total MAT for August, 2015 at INR. 16.18 crores.
The company further submitted that it need to be appreciated that NPPA has failed to accurate calculate the ceiling price of ranitidine injection - 25MG/ML. There was no rational for not considering our formulation “Rantac injection 5 x 2ML” each 1ml containing Ranitidine injection - 25MG/ML especially when JBCPL covers over 30% MAT value. The ceiling price of “Ranitidine injection - 25MG/ML” is not correctly calculated considering all manufacturers over 1% market share and the consequently notified price is not as per the provisions of Para 4 of DPCO, 2013.
The petitioner stated that it has been aggrieved by the fact that the ceiling price of the captioned formulation Ranitidine injection - 25MG/ML was not correctly notified under S.O. 3431 (E) dated 10th November, 2016 due to exclusion of our formulation with over 30% market share.
During examination of the review petition, the DoP noted that as per instructions of DoP vide letter No.F.No.31015/44/2016-PI.I, dated 11.7.2016 NPPA was directed to henceforth place a draft version of the Price Calculation Sheets for the proposed revised price notification, including wherever applicable, the Price to Retailer (PTR) and Moving Annual Turnover (MAT) values adopted for calculations, on the website of NPPA for 10 clear working days to invite comments from the affected pharmaceuticals firms. Only after taking into account the comments or any additional data thus received within the given time period, the NPPA shall finalize the Ceiling and the Retail Prices. Accordingly, NPPA uploaded draft working sheet of proposed ceiling price of this formulation also on its website.
This was displayed on the website of NPPA for 10 clear working days. M/s J. B. Chemicals & Pharmaceuticals Limited did not make any representation against the proposed ceiling price uploaded on NPPA?s website. The company admitted that it did not submit an objection to the draft ceiling price as the draft was released during the holiday period and was missed out by the company. Although the company did not avail the opportunity, however, the company filed the review application under para 31 of DPCO,2013, to get its grievance settled. It is observed that there is a merit in the grievance of the petitioner company that NPPA missed out certain data/information while fixing the ceiling price of the formulation Ranitidine 25mg/ml Injection.
Therefore, Hearing Authority is of the opinion that NPPA may be directed to examine the relevant document/information submitted by the petitioner company and to re-fix the ceiling price of Ranitidine 25mg/ml on merit, the DoP stated.