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Sun Pharma gets favourable review from DoP on ceiling price of “Imatinib mesylate 100 mg tablet”
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Ramesh Shankar, Mumbai
November 18 , 2016
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The Indian pharmaceutical major Sun Pharma Laboratories Ltd has received
favourable review order from the Department of Pharmaceuticals (DoP) on
fixation of ceiling price of “Imatinib mesylate 100 mg tablet” as the
DoP has directed the national drug price regulator NPPA to examine all
the relevant documents/information furnished by the petitioner company
again and to re-fix the ceiling of imatinib mesylate 100 mg tablet, on
merit”.
The DoP made this order while disposing of the review
application filed by Sun Pharma against fixation of ceiling price of
“Imatinib mesylate 100 mg tablet” vide NPPA notification S.O. No.
2730(E) dated 17.08.2016 issued under Drugs (Prices Control) Order, 2013
(DPCO, 2013).
In the review application, the petitioner stated
that they are aggrieved by the said notification as the price
calculation shown in the working sheet dated 19.08.2016, incorrectly
captured our price details. They therefore sought a review of the same
under paragraph 31 of DPCO 2013 on the grounds that in the working sheet
showing calculation of ceiling price displayed on the website of NPPA
on 19.08.2016, the ceiling price was revised as Rs. 71.66 per tablet.
Draft
working sheet for ceiling price fixation of imatinib mesylate was
presented on NPPA website on 15.07.2016, and companies were to respond
to the office of NPPA in case of any data discrepancy by 10 working days
of the draft working sheet publication. In draft working sheet, PTR of
their product Imalek 100 mg tablet 10 was shown captured incorrectly as
Rs. 700.72 per pack of 10 tablets, while the prevalent PTR was Rs.
772.74 per pack of 10 tablets in August 2015. They had presented their
position through a representation dated 26.07.2016 of the office of NPPA
on correcting the PTR with supporting documents. However, their plea
was not considered in the ceiling price calculation, evidenced from the
working sheet of price notification SO No. 2730(E), showing PTR of
Imalek 100 mg tablet 10as Rs. 700.72 instead of Rs. 772.74 as requested.
In reply, the NPPA commented that it has fixed the ceiling
price for imatinib mesylate 100mg tablet of Rs. 87.59/tablet vide S.O.
1827(E) dated 21.6.2013 and the same was revised to Rs. 93.13, Rs. 96.71
& Rs. 94.09 per tablet vide S.O. 1156(E), 619(E) & 644(E) dated
28.4.2014, 26.02.2015 & 02.3.2016 respectively under NLEM 2011.
Under NLEM 2015, the ceiling price for this pack was notified as Rs.
71.66/tablet vide S.O. 2730(E) dated 17.8.2016 under para 4, 10, 11, 14,
16, 17 & 18 of DPCO, 2013 based on pharmatrac data for August 2015
as per existing practice. (ii) As per information available with M&E
division (through IPDMS report), the company is not following ceiling
price for subject formulation notified vide S.O. 2730(E) dated
17.8.2016.
On examining the review petition, the reviewing
authority DoP noted that the only grievance of the petitioner company is
that the actual PTR of their formulation Imalek 100 mg tablet for a
pack of 10 tablets was Rs. 772.74, applicable in the month of August,
2015, whereas NPPA has taken the PTR of the product as Rs. 700.72 for a
pack of 10 tablets, in the working sheet while calculating the ceiling
price of imatinib mesylate 100 mg tablet. The company representative
also submitted documentary proof in support of their claim. NPPA
representative stated that the same will be examined after receipt of
relevant document/information. On going through the calculation sheet,
it is observed that the contention of the petitioner company has got
merit and needs examination by NPPA. In view of the above, Hearing
Authority of the opinion that NPPA may be directed to examine the
relevant document/information submitted by the petitioner company and to
re-fix the ceiling price of imatinib mesylate 100 mg. tablet, on merit.
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