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Sun Pharma gets favourable ruling from DoP on its review petition against price fixation of “Volitra Enzo tablet”
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Ramesh Shankar, Mumbai
August 30 , 2017
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Pharma major Sun Pharmaceutical Industries has received favourable
ruling form the Department of Pharmaceuticals (DoP) on its review
petition against price fixation on “Volitra Enzo tablet” containing
formulation trypsin 48 mg + bromelain 90 mg + rutoside trihydrate BP 100
mg + diclofenac sodium IP 50mg. The DoP has now directed the NPPA to to
revise/refix the retail price of “Volitra Enzo tablet” by considering
only those medicines/formulations having MAT value of more than 1%
market share, as DPCO does not recognize a company for average PTR but
only medicines/formulations.
Earlier, Sun Pharmaceuticals had
filed a review application with the DoP against price fixation of
“Volitra Enzo tablet” by the NPPA vide its order No. S.O. 4131(E), dated
22.12.2016 under DPCO 2013.
In the review application dated
17.01.2017, the petitioner contended that the working sheet uploaded on
NPPA website dated 23.12.2016 suggested to have considered 15 packs in
the retail price calculation. It is observed that 1 pack viz. TRYBR-D
48/100/90/50mg tablet 10 of Indoco Remedies has been captured in the
calculation despite having market share less than 1%.
Further,
the company referred to Notification S.O. 4131 (E), wherein two details
are appearing ambiguous. Table title column No. 2 mentioned as Scheduled
Formulation, and footnote (f) where its suggested to furnish quarterly
return to NPPA in respect of production/import and sale of product in
Form-III of Schedule-II of DPCO 2013. They submitted that the captioned
formulation is a Non-Scheduled Formulation, and hence applicability of
Form-III, Form IV does not stand appropriate in this case. Therefore,
term Scheduled Formulation, and footnote (f) should be removed for
transparent instruction and compliance.
On examination of the
matter, DoP noted that it is seen from the calculation sheet that NPPA
has clubbed the market share of two brands of Indoco Remedies. DPCO
does not recognize a company for average PTR but only medicines /
formulations. Hence, NPPA has wrongly considered the PTR of TRYBR-D
48/100/90/50mg tablet 10’s pack, having only 0.74% share. Therefore,
NPPA may be directed to consider only those medicines / formulations
having MAT value of more than 1% market share.
Further, the DoP
noted that as the product of the petitioner company is a ‘new drug’, and
is not a scheduled formulation, the word ‘scheduled formulation’ should
be removed from the column (2) of Table in SO No.4131(E), dated 22nd
December, 2016. As per Schedule II of DPCO, 2013, Form III & Form IV
are to be filled up for scheduled formulations only. Hence, Note (f) of
the notification also needs to be removed.
“NPPA is hereby
directed to revise/refix the retail price of “Volitra Enzo tablet”
containing formulation trypsin 48 mg + bromelain 90 mg + rutoside
trihydrate BP 100 mg + diclofenac sodium IP 50mg. by considering only
those medicines/formulations having MAT value of more than 1% market
share, as DPCO does not recognize a company for average PTR but only
medicines / formulations.
“NPPA is further directed to remove
the word ‘scheduled formulation’ in Column (2) of table and Note (f) of
the notification for this product, since the subject product is a ‘new
drug’”,the DoP in its order said.
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