New Delhi: The Department of Pharmaceuticals (DoP) has accepted Sun Pharmaceutical’s review petition against price fixation of “Methylprednisolone Injection 40mg/ml” and has directed the NPPA to take the opinion of Expert Committee on whether formulation IVEPRED 40 MG INJECTION 1 ML is a scheduled drug or not and fix the ceiling price of Methylprednisolone Inj 40 mg/ml accordingly.”
Sun Pharmaceutical Industries Limited had filed a review petition under paragraph 31 of the Drugs (Prices Control) Order, 2013 against notification S.O. No.248(E), dated 24.01.2017 issued by the National Pharmaceutical Pricing Authority (NPPA) fixing the ceiling price of Methylprednisolone Injection 40mg/ml.
NPPA had fixed revise price Methylprednisole 40mg/ml Injection Rs. 44.53 per ml which was challenged by the petitioner contending that the PTR of its product Depopred 40mg injection 1ml & Depopred 40mg injection 2ml was taken incorrectly in the working sheet while computing the ceiling price. The company has also pointed out that PTR of Depo Medrol 40mg injection 5ml has included in the working sheet having less than 1% market share. The company also challenged the inclusion of their product Ivepred 40mg Injection in the working sheet being a Lyophilized version of methylprednisole 40mg/ml Injection.
Giving the reply, NPPA stated that it has fixed the ceiling price for methylprednisole 40mg/ml injection as per the data provided by pharmatrac for the month of August 2015. Intas Pharmaceuticals Limited, Pfizer Limited and Neon Laboratories has also submitted representation prior to notification. The representation of Sun Pharma Laboratories Ltd along with the representation of other companies was examined and the same was not considered in the Authority meeting.
At the time of examination of the case, the DoP noted that PTR of two formulations – Depopred 40MG Injection 1ml and Depopred 40mg injection 2ml, being wrongly considered by NPPA. 1 pack Depo Medrol 40mg Injection 5 ml with less than 1% market share has been considered and it was observed from the calculation sheet that NPPA has erred in considering the PTR of this formulation by combining the total market share of this brand of M/s Pfizer Ltd. DPCO does not recognize a company for average PTR but only medicines/formulations.
Further, the company stated that Ivepred 40mg injection 1ml pack, being a lyophilized version of Methylprednisolone Inj 40 mg/ml is a non-scheduled formulation and should be excluded from ceiling price calculation. In support of their claim, the company submitted sample pack of Ivepred 40mg Injection 1ml to confirm its composition.
Giving the decision, DoP stated “NPPA is hereby directed to examine the documents submitted by the petitioner company about the actual PTR of two formulations – Depopred 40MG Injection 1ml and Depopred 40mg injection 2ml and after getting confirmation of Pharmatrac under intimation to the petitioner, examine the ceiling price of the subject formulation, on merit.”
“NPPA is also directed to refix the ceiling price of the subject formulation by excluding the PTR of Depo Medrol 40mg Injection 5ml having a market share of Page 6 of 6 only 0.11% (less than 1%), as DPCO does not recognize a company for average PTR but only medicines/formulations.”
“NPPA is further directed to take the opinion of Expert Committee on whether formulation IVEPRED 40 MG INJECTION 1 ML is a scheduled drug or not and fix the ceiling price of Methylprednisolone Inj 40 mg/ml accordingly.”
Below is the attachment for the same.