The Department of Pharmaceuticals (DoP) has directed the National Pharmaceutical Pricing Authority (NPPA) to examine any relevant data furnished by Wockhardt for reviewing the ceiling prices of Erythropoietin Injection 2000 IU and 10000 IU. The NPPA through its notification No. S.O. No.1405(E) dated 12.04.2016 had fixed the ceiling prices of erythropoietin Injection 2000 IU and 10000 IU.

Aggrieved by the notification, Wockhardt submitted a review application under paragraph 31 of the DPCO against NPPA order No. S.O. 1405(E) dated 12/04/2016 for price fixation of erythropoietin Injection 2000 IU and 10000 IU.

In the review petition, the petitioner stated that they are manufacturing and marketing the formulations erythropoietin – 2000 IU/ml and erythropoietin – 10000 IU/ml in three different packs under their trademarks WEPOX 2000 IU & WEPOX 10000 IU respectively. The said formulations are now scheduled formulations as per the NLEM, 2015 which is notified on 23rd December, 2015. They further submitted that now the ceiling price of above said formulation is fixed vide Notification no. S.O 1405(E) dated 12/04/2016 under para 4,10, 11, 14, 16, 17 and 18 of DPCO, 2013 viz. a. Erythropoietin-2000 IU/ml Rs. 562.49 for each pack and erythropoietin- 10000 IU/ml Rs. 2349.76 for each pack.

In the personal hearing held on 31.5.2016, the petitioner stated that the data of various companies have not been considered while fixing the price of erythropoietin Injection 2000 IU and 10000 IU. They submitted that Wockhardt Ltd itself is marketing erythropoietin Injection in different dose forms that too have not been taken into account by NPPA for arriving at price fixation for the purpose. The company also submitted that different doses form have different therapeutic advantages to the patients.

They requested this department to direct NPPA to withdraw the notification related to the above-said formulation.

In reply, the NPPA stated that erythropoietin injection 2000IU/ml and 10000 IU/ml are included under section 10.1.1 & 10.1.2 of NLEM, 2015. NPPA has fixed ceiling price Rs. 562.49 for erythropoietin injection 2000 IU per pack and Rs. 2349.76 for erythropoietin injection 10000 IU per pack. The company has not submitted any representation as per NPPA OM File No. 19(714)/2016/Div. II/DP/NPPA dated 11.4.2016 while other major companies have submitted their representations along with supporting documents like copy of Invoices indicating Price to Retailer (PTR) and Moving Annual Turnover (MAT value) and samples of Aug. 2015 (dully self attested) as requested in OM dated 11/20.5.2016.

After hearing both the parties, the reviewing authority, DoP, ordered, “Any relevant data being furnished by the petitioner company to the NPPA may be examined by NPPA on merits and orders issues within one month of this decision. In view of the above, the present review petition stands disposed off”.