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.”