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DoP directs NPPA to take Expert panel's opinion on separate ceiling prices based on pack sizes of methylprednisole injection
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Ramesh Shankar, Mumbai
November 13 , 2017
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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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