DoP rejects Sun Pharma's review petition against ceiling price fixation of “Lithium 300 mg”
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Ramesh Shankar, Mumbai
June 24 , 2017
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The Department of Pharmaceuticals (DoP) has rejected the pharma major
Sun Pharm's review application against the ceiling price fixation of
“Lithium 300 mg” by the NPPA vide its order No. S.O. 3181(E), dated
07.10.2016 issued under Drugs (Prices Control) Order, 2013 (DPCO 2013).
In
the review petition, the petitioner contended that they are aggrieved
by the said notification as the ceiling price calculation has not taken
the correct price data and as per provision of DPCO 2013, hence the
revision in ceiling price is not justified. They contended that the NPPA
has notified the ceiling price of Lithium 300 mg Tablet via S.O. No.
3181(E) dated 07.10.2016 without considering their representation. This
in turn has led to the fixation of ceiling price based on incorrect PTR
data, which is not correct as per the provision of DPCO 2013.
Considering such scenario, it seems that overall purpose of bringing
transparency in ceiling price calculation/fixation is being defeated.
In reply, the NPPA commented that in this regard, it is mentioned that ceiling price of Rs.1.35/tablet
for Lithium 300mg tablet was notified vide S.O. 3181(E) dated
07.10.2016 as per para 4, 10, 11, 14, 16, 17 & 18 under DPCO 2013.
NPPA has considered the actual PTR of Lithosun 300mg tablet as provided
by Pharmatrac database by (AIOCD-AWAC) for the month of August, 2015.
NPPA examined the representation submitted by Sun Pharma Laboratories
Ltd. the same was sent to pharmatrac for confirmation. Pharmatrac
confirmed that earlier data as submitted by Pharma Trac was correct.
Ceiling price Rs.1.35/tablet notified for
Lithium 300mg tablet is based on correct PTR. Therefore representation
made by Sun Pharma was not considered by NPPA.
During
examination, the DoP noted that the petitioner company has challenged
the NPPA Order S.O. 3181(E), dated 07.10.2016 for price fixation of
their formulation Lithium 300 mg. on the ground that NPPA has not
included actual PTR of Lithosun 300 mg tablet which is applicable in
August, 2015. The representation submitted by the company in this regard
against the draft working sheet was not considered by NPPA.
The
DoP further noted that the NPPA clarified that the actual PTR of
Lithosun 300mg tablet was considered as provided in Pharmatrac database
for the month of August, 2015. The representation submitted by Sun
Pharma Laboratories Limited was examined by NPPA and sought confirmation
from Pharmatrac. Pharmatrac confirmed that earlier data as submitted
was correct and the ceiling price Rs.1.35/tablet
notified for Lithium 300mg tablet is based on correct PTR. Therefore,
the representation made by Sun Pharma Laboratories Limited was not
considered by NPPA.
In view the above, since the representation
of the petitioner company was duly examined by NPPA and Pharmatrac also
confirmed the data submitted earlier, there remains no point in
considering the representation of the petitioner company. Therefore, the
representation of the petitioner company may be rejected, it noted.
“The grievance raised by Sun Pharma Laboratories Ltd. in their review
petition has got no merit and hence the petition stands rejected,” the
DoP order said.
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