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No provision in DPCO to consider gelatin coating differently for fixing of ceiling prices: DoP
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Ramesh Shankar, Mumbai
June 22 , 2017
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The Department of Pharmaceuticals (DoP) has ruled that there is no
provision in DPCO to consider gelatin coating differently for fixing of
ceiling prices of drugs. The DoP's ruling in this regard came while
examining a grievance by Sanofi India that the price of formulation
“Cetirizine 10 mg capsules” should not be considered being soft gelatin
capsule and not covered in Schedule I of DPCO, 2013.
Earlier,
Sanofi India filed a review application against the price fixation of
“Cetirizine 10 mg capsules” by the NPPA through its order No. S.O.
247(E), dated 24.01.2017 issued under DPCO 2013.
In the review
application, the petitioner contended that considering that there was an
apparent error in the draft version of proposed price calculation sheet
for the proposed ceiling price in respect of 'Cetirizine 10 mg capsules
displayed on NPPA website which was uploaded on 6th December 2016, it
made a detailed representation to NPPA vide letter dated 7.12.2016
justifying that CETGEL 10 mg capsules manufactured by Universal Medicare
Private Limited and marketed by Sanofi India Limited are soft-gelatin
capsules as per the manufacturing license issued to the company by the
concerned drug controller and these capsules are totally different than
those listed in Section 3.2 of Schedule I to the DPCO 2013. However,
NPPA has notified the ceiling price of 'Cetirizine 10 mg capsules as per
S.O. 247(E) dated 24.1 2017 without considering the justifications
furnished to NPPA.
During the examination of the case, the DoP
noted that the petitioner company has challenged the NPPA Order S.O.
247(E), dated 24.01.2017 for price fixation of their formulation
Cetirizine 10 mg capsules on the ground that NPPA has erred by
considering their formulation “Cetirizine 10 mg capsules (CETGEL 10mg)”,
manufactured by Universal Medicare and marketed by Sanofi, as the
formulation is a soft gelatin capsule and is totally different than
those listed in section 3.2 of NLEM 2015. The company claimed that
Schedule I refers only to tablets, ceiling prices would not apply for
Cetirizine soft-gelatin capsules.
The DoP further noted that in
this connection the stand of NPPA is in order as Cetirizine 10 mg
capsules is added/included under section 3 of NLEM 2015. NPPA has
considered the PTR and MAT value of their formulation Cetirizine 10 mg
capsules for working out the ceiling price of this formulation, which is
in conformity with the provisions of explanation to note(1) of DPCO
S.O. 701(E) dated 10.3.2016, which says that if a tablet is included,
other dosage forms like conventional tablets and capsules are considered
as included. Moreover, there is no provision in DPCO to consider
gelatin coating differently.
“The grievance of Sanofi India
Limited that the price of formulation “Cetirizine 10 mg capsules” should
not be considered being soft gelatin capsule and not covered in
Schedule I of DPCO, 2013, cannot be acceded to as Cetirizine 10 mg
capsules is included under section 3 of NLEM 2015 and there is no
provision in DPCO to consider gelatin coating differently,” the DoP
ordered.
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