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DoP rejects review petition on sodium valproate 200 and 500 mg tabs; amiodarone tablets 100 mg; & leflunomide 10 and 20 mg tabs
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Ramesh Shankar, Mumbai
December 23 , 2016
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The Department of Pharmaceuticals (DoP) has rejected the review
application filed by Sanofi-Synthelabo (India) Pvt. Ltd. against the
price fixation of “Sodium valproate 200 mg and 500 mg tablets;
amiodarone 100 mg tablets; and leflunomide 10 mg and 20 mg tablets”.
The
NPPA had earlier fixed the ceiling prices of “Sodium valproate 200 mg.
and 500 mg. tablets, amiodarone tablets 100 mg. and leflunomide 10 mg.
and 20 mg. tablets” vide its order No. S.O. 2193(E) [corrected SO
No.2195(E)] dated 23.06.2016 issued under Drugs (Prices Control) Order,
2013 (DPCO 2013).
In the review application, the petitioner had
contended that the ceiling prices for the above product have been fixed
by considering the PTR of August 2015 and applying the WPI decrease of
2.7105% as per the annual wholesale price index (WPI) for preceding
calendar year. The price fixation of the above formulations are not in
consonance with the NPPP 2012 and the relevant provisions of the DPCO
2013.
During examination, the DoP noted that the petitioner
company has challenged the NPPA Order S.O. 2193(E)[corrected SO
No.2195(E)] dated 23/06/2016 for price fixation of their formulations
listed therein. The main contentions of the petitioner company included
that the revision of ceiling price of those drugs whose prices had
already been fixed, should not be fixed again before the expiry of 5
years from the date of original fixation of the ceiling price. The
ceiling prices should not be fixed by taking basis PTR August, 2015 by
deducting negative WPI as applicable as on 1st April, 2016. Para 18(i)
of DPCO 2013 clearly states that the revision of ceiling prices on the
basis of moving annual turnover value shall be carried out “as and when
the National List of Essential Medicines is revised by the Ministry of
Health and Family Welfare or five years from the date of fixing the
ceiling price under this Order whichever is earlier.”
In view of
this, NPPA has revised the ceiling prices of the formulations strictly
as per the provision of DPCO 2013. As regards the other point that
negative WPI should not be taken while fixing the ceiling price vide
notification dated 2.6.2016, since the drugs are not new drugs in NLEM
2015, the WPI impact has to be taken care of while fixing the ceiling
prices. Therefore, the petitioner company has no merit in the petitions
and may be rejected.
After hearing both the parties, the DoP
ordered, “The issues raised by the petitioner company in the review
petition have no merit and hence the review petitions are hereby
rejected.”
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