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DoP directs NPPA to refix ceiling prices of cefriaxone 1 gm injection strictly in accordance with DPCO, 2013
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Ramesh Shankar, Mumbai
November 01 , 2017
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The Department of Pharmaceuticals (DoP) has directed the National
Pharmaceutical Pricing Authority (NPPA) to refix the ceiling prices of
the formulation Xone 1 gm (cefriaxone 1 gm injection) by considering
only those medicines/formulations having MAT value of more than 1%
market share, strictly in accordance with DPCO, 2013.
The DoP's
direction in this regard came during the examination of a review
petition filed by Alkem Laboratories against the price fixation of “Xone
1 gm (cefriaxone 1 gm injection)” by the NPPA through its order No.
S.O. 1271(E), dated 21.04.2017 issued under DPCO 2013.
In the
review application, Alkem Laboratories contended that the revision of
the ceiling price of Xone 1gm has not been exercised in accordance with
the letter and spirit of the DPCO particularly terms of the provisions
of paragraphs 4 and 18 of the DPCO 13. In the working sheet of ceiling
price calculation, NPPA has considered company levelwise MAT while in
DPCO 13 there is no such provision. The product became a controlled
formulation for the first time in May 2013, when DPCO 2013 was notified.
Subsequent to the same the ceiling price of the product was fixed for
the first time as Rs.55.44 vide S.O. on
2235 (E) dt 22.07.2013. Further the ceiling were notified under para 16
for revision in WPI vide S.O 1156 dt 28.04.2014 as Rs.58.94, S.O. 619(E) dt 26.02.2015 as Rs.61.21, S.O. 644(E) dt 02.03.2016 as Rs.59.55.
The
company further stated that subsequent to the S.O. 644, NPPA
recalculated and renotified the Ceiling Price based on para 18, vide
S.O. 1686 dt 09.05.2016 as Rs.47.95. Hence the ceiling price have been worked out by NPPA under para 18 in S.O. 2235 on 22.07.2013 and S.O.1686 on 09.05.2016.
During
the examination of the matter, the DoP noted that, it is found that
NPPA has erred in calculating ceiling price as per para 4 of DPCO, 2013.
It clearly mentions that the medicines having PTR and MAT value of more
than 1% market share are to be taken for calculation. In the instant
case, the principles applied by NPPA go beyond what is mentioned in
DPCO. Hence, NPPA may be directed to refix the ceiling price in
accordance with the provisions of DPCO.
After hearing both the
parties, the DoP ordered, “NPPA is directed to refix the ceiling prices
of the formulation Xone 1 gm (cefriaxone 1 gm injection) by considering
only those medicines / formulations having MAT value of more than 1%
market share, strictly in accordance with DPCO, 2013.”
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