The Department of Pharmaceuticals (DoP) has directed the NPPA to consider the information/documentary evidence submitted by pharma major Pfizer Limited in respect of actual PTR of their formulation Pitocin 0.5ml injection and refix/revise the ceiling price of Oxytocin injection 10IU/ml, after verification, on merit.

Examining a review petition filed by Pfizer Limited against price fixation of their formulation “Pitocin 0.5ml injection (containing Oxytocin injection 10IU/ml), the DoP noted that the contention of the petitioner company is that NPPA has not considered the actual PTR of their formulation Pitocin 0.5ml injection (containing Oxytocin injection 10IU/ml.) while fixing the ceiling price of Oxytocin injection 10IU/ml. According to the petitioner company, the actual PTR of their formulation is Rs.17.88 per 0.5ml whereas NPPA has considered PTR of Rs.17.23 per 0.5ml.

In the review petition, the petitioner pointing out that the Price to Retailer (PTR) for company’s formulation Pitocin 10IU injection per 0.5 ml has been incorrectly considered by the NPPA in their draft price calculation sheet. In spite of pointing out the errors in the draft price calculation sheet and providing valid supporting documents, NPPA ignored company’s representation completely and without providing the company an opportunity in this regard arbitrarily fixed and notified the ceiling price of Pitocin 10IU Injection per 0.5 ml under S.O. 1009(E) dated March 30, 2017.

In the price working sheet to the Notification No. S.O. 1009(E) dated 30.3.2017, NPPA has considered a PTR as Rs.17.23 whereas the PTR for this formulation was Rs.17.88. If the correct price of their formulation was taken into consideration as above, the average ceiling price would have changed to Rs.38.67 per ml as against Rs.37.27 per ml i.e. after considering WPI increase of 1.97186%, the petitioner further contended.

In reply, the NPPA commented that the ceiling price Rs.37.27/ml is notified for Oxytocin injection & the same was revised to Rs.35.74/ml vide S.O. 2058 (E) dated 30.06.2017 as per Para 4, 6, 10, 11, 14, 16, 17, & 18 of DPCO, 2013. The company has stated that correct methodology was not followed in arriving at the ceiling price of Oxytocin injection 10IU/ml. The points raised by the company are not relevant. Price fixation has been done strictly in accordance with the provisions of DPCO, 2013.

After hearing both the parties, the DoP ordered, “NPPA is hereby directed to consider the information/documentary evidence submitted by the company in respect of actual PTR of their formulation Pitocin 0.5ml injection and refix/revise the ceiling price of Oxytocin injection 10IU/ml., after verification, on merit.”