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DoP directs NPPA to revise ceiling prices of “Paclitaxel injection, Carboplatin & Cisplatin” strictly as per para 4 of DPCO 2013
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Ramesh Shankar, Mumbai
September 28 , 2016
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The Department of Pharmaceuticals (DoP) has directed the NPPA to revise
the ceiling prices of “Paclitaxel injection, Carboplatin &
Cisplatin” in the light of para 11(3) of DPCO, 2013 and strictly in
accordance with para 4 of DPCO 2013.
Earlier, Fresenius Kabi
India Private Ltd had filed three review applications dated 19.5.2016
under para 31 of DPCO against NPPA Notifications SO No.1560(E) dated
27.4.2016 and NPPA’s working sheet related to price notified on
27.4.2016 for price fixation of “Paclitaxel injection, Carboplatin &
Cisplatin”.
Examining all the three review applications, the
DoP noted that the said review petitions were filed against S.O.
No.1560(E) dated 27.4.2016 for fixation of the ceiling prices under
DPCO, 2013, due to amendment in Schedule-I of DPCO, 2013 on 10th March,
2016 using Para 17 & 18 of DPCO, 2013. In this regard, it is
observed that the ceiling prices of all the three products were fixed on
5.11.2013, 28.6.2013 & 22.7.2013 after announcement of the DPCO,
2013. After that the ceiling price revised upward two times on 28.4.2014
& 26.2.2015 due to change of WPI as Para 16 of DPCO, 2013 and
ceiling price revised downward one time on 2.3.2016 due to reduction in
WPI. Hence, the issue raised by the petitioner company has no merit.
The
base PTR price for all the three cases for all Division prices is old
one, i.e. of May, 2012 and the ceiling price revised per pack and not
per ML, but due to amendment in Schedule-I, the revision in the ceiling
price is based on per ML basis and by considering the new PTR of all
products (Aug, 2015), combined with all different pack sizes such as
5ml, 30ml, 50ml & 100ml etc., which is not correct. Company in its
representations stated that the ceiling price for all the products
should be fixed per ml for each pack size as per Para 11(3) of DPCO,
2013.
As regards company’s request for separate ceiling price
for the formulations as per para 11(3) of DPCO, 2013, notified by SO
1152(E), dated 2.4.2016, the company representatives prayed that all
packs of equal pack size and strength to be considered for ceiling price
calculation and different price for different pack size as per para
11(3) of DPCO 2013 be granted. In this connection, para 11(3) of DPCO,
2013 may kindly be read as under:- “(3) Notwithstanding anything
contained in sub-paragraph (1) and (2), the case of injections or
inhalation or any other medicine for which dosage form or strength or
both are not specified in the Schedule-I of the Drugs (Prices Control)
Order, 2013, the Government may fix and notify separate ceiling price 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, conforming to Indian Pharmacopoeia or
other standards as specified in Page 7 of 7 the Drugs and Cosmetic Act,
1940 (23 of 1940) and the rules made thereunder for the same
formulation.”
The NPPA representative, during the hearing,
stated that company’s representation regarding ceiling price fixation
for above said formulations under para 11(3) of DPCO, 2013 is under
examination. After hearing the company as well as NPPA, hearing
authority is of the opinion that NPPA may be directed to re-examine all
the three cases and re-fix/revise the ceiling price under para 11(3) of
DPCO, 2013, if considered necessary.
“NPPA is directed to revise
the prices within one month of this order of all the three cases of the
petitioner company in the light of para 11(3) of DPCO, 2013 and
strictly in accordance with para 4 of DPCO 2013. The present review
petition stands disposed off”, the DoP in its order dated September 19,
2016 said.
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