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DoP rejects review application by Lupin against fixation of ceiling price of “ramipril + amlodipine tablets”
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Ramesh Shankar, Mumbai
October 27 , 2016
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The Department of Pharmaceuticals (DoP) has rejected the review
application filed by Lupin against the fixation of ceiling price of
“ramipril + amlodipine tablets” by the national drug price regulator the
National Pharmaceutical Pricing Authority (NPPA).
Lupin had
earlier filed the review application under paragraph 31 of the Drugs
(Prices Control) Order, 2013 against notification S.O. No.1213(E) dated
06.05.2015 issued by the NPPA fixing the retail price of their new drug,
“ramipril + amlodipine tablets”.
In the review application, the
petitioner mentioned that the monopoly condition under para 6 should not
have been applied in their case as para 5 does not deal with scheduled
formulations while para 6 deals with scheduled formulations. Further,
Form I, i.e. form for fixation of retail price of new drug, does not
specify para 6.
In reply, the NPPA stated that DPCO provides
only 2 formulae for price fixation, i.e. average basis under para 4(1)
and monopoly basis under para 6(1). Since, only one manufacturer exists,
price has been fixed by applying monopoly condition as per para 6(1) of
DPCO 2013. Para 6 refers to those cases where price fixation has been
carried out by using para 4 and the formula prescribed in para 4 is
applicable for both scheduled and new drug. This has been done uniformly
in all other similar cases. NPPA further mentioned that paras quoted in
Form I are not for fixation of prices, it is only for submission of
information to NPPA. For price fixation in DPCO, 2013, average formula
of para 4 for more than one manufacturer and monopoly formula of para
6(1) for single manufacturer is applicable.
During examination,
reviewing authority DoP noted that the company representative stated
that the price should have been fixed under para 5 and that para 6
applies to only scheduled drugs and does not apply to new drugs. The
NPPA representative stated that as per available data, there was only
one manufacturer and hence monopoly formula has been applied by NPPA.
In
case of new drug price fixation, para 5(1) of DPCO 2013 refers to para
4(1). Para 4(1) provides methodology for fixing ceiling prices of
scheduled formulations. Therefore, intention of framers of DPCO is to
fix new drug prices with same methodology as for scheduled formulations.
Para 6(1) stipulates that if there is no reduction in case of
application of para 4(1), the monopoly method contained in para 6 will
apply. The company has no merit in arguing that their formulation is not
scheduled and, therefore, monopoly condition does not apply.
After
examining the matter, the DoP in its order dated October 6, 2016, said,
“The points raised by the petitioner company have no merit. Therefore,
the review application of the petitioner may be rejected”.
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