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DoP directs NPPA to take Expert panel's opinion on separate ceiling prices based on pack sizes of methylprednisole injection

Ramesh Shankar, Mumbai
Saturday, November 11, 2017, 08:00 Hrs  [IST]

The Department of Pharmaceuticals (DoP) has directed the NPPA to take the opinion of Committee of Experts to examine and recommend whether separate ceiling price based on its pack sizes be fixed and also the therapeutic rationale of the formulation methylprednisolone sodium succinate powder for injection, to decide about separate pricing of methylprednisolone injection as suspension for injection and methylprednisolone sodium succinate powder for injection.

While examining the review petition filed by pharma major Cadila Healthcare Limited against price fixation of their formulation “Methylprednisolone 40mg Injection” by the NPPA through its order No. S.O. 248(E), dated 24.01.2017 issued under DPCO 2013, the reviewing authority DoP directed the NPPA to examine the recommendation of the Expert Committee to take a decision about refixation/revision of ceiling price of methylprednisole 40mg/ml injection, on merit.

Cadila Healthcare had earlier filed a review application against price fixation of “Methylprednisolone 40mg injection”. In this petition, the petitioner contended that the price fixed by NPPA for schedule formulation methylprednisolone 40mg Injection vide ceiling price order no. S.O. 248(E) dated 24.01.2017 at sr. no. 22 of the order is not correct. The working sheet of methylprednisolone injection placed on NPPA’s website for calculation of ceiling price has anomaly that ceiling prices fixed and notified by NPPA for methylprednisolone injection vide notification no. 248(E) on 24.01.2017 is based on per ml average and includes various packs of differing sizes (1ml, 2ml, 5ml). Considering per ml price of 2 ml and 5 ml together for one pack of 40mg in powder is not correct. It can also be seen from the working sheet that there is an anomaly in PTR for 5ml pack and 1ml pack at sr. 8 and 9 i.e. Rs.50.29 for 5ml and Rs.57.33 per 1ml of same brand, the PTR of 5ml pack is lower than that of 1ml pack.

The petitioner contended that there is gross error in the working sheet of methylprednisolone injection. Moreover, the pack of their product Depotex 40 injection is in powder form and as per license the composition is “Each vial contains: Methylprednisolone sodium succinate USP equivalent to Methylprednisolone 40mg.” In view of above, the company urged that the ceiling price for Methylprednisolone injection should be reworked by NPPA considering the correct pack and notify the separate price for liquid injection as well as powder injection.

The DoP while examining the case noted that the NPPA has fixed the ceiling price of methylprednisole 40mg/ml injection by considering the PTR of 1ml, 2ml and 5ml pack sizes. NPPA also considered the per ml PTR of company’s product Depotex 40 injection and various other formulations, which are in powder form having different composition for fixing the ceiling price of subject formulation. The petitioner company, in support of their claim, has submitted that the therapeutic advantage of methylprednisolone sodium succinate powder for injection is that it is soluble in water and may be administered in a small volume of diluents and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. The company further stated that sterile powder form of injection is technologically advanced form of injection and manufacturing cost involved in such form of injection is very high as compared to suspension for injection.

Keeping in view the therapeutic advantages elaborated by the company, it is proposed that NPPA may be directed to refer the matter to Expert Committee for their opinion. There is a provision in DPCO as per Para 11(3&4) that a Committee of Expert may recommend fixing of separate ceiling price of scheduled formulations or retail price for such formulations with specific therapeutic rationale, considering the type of packaging or pack size, or dosage compliance or content in the pack namely liquid, gaseous or any other form, in the unit dosage as the case may be.

 

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