The Department of Pharmaceuticals (DoP) has rejected Sanofi India's review application against price fixation of enoxaparin 40mg/0.4ml and enoxaparin 60mg/0.6ml.

Earlier, the National Pharmaceutical Pricing Authority (NPPA) vide its order No. S.O. 2963(E) dated 15.09.2016 had fixed the ceiling price of enoxaparin 40mg/0.4ml and enoxaparin 60mg/0.6ml under DPCO, 2013. Aggrieved by the NPPA notification, Sanofi India filed a review petition under paragraph 31 of the DPCO, 2013.

In the review application, the petitioner 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.

In reply, the NPPA commented that for enoxaparin 40mg, NPPA has fixed the ceiling price of Rs.439.39 per pack vide S.O 2246(E) dated 22.7.2013 and the same was revised to Rs.467.16, Rs.485.14 & Rs.471.99 per pack vide S.O. 1156(E), 619(E) & 644(E) dated 28.4.2014, 26.02.2015 & 02.3.2016 respectively. Ceiling price for enoxaparin 60mg was fixed Rs.534.98 per pack vide S.O. 1917(E) dated 28.6.2013 and the same was revised to Rs.564.54, Rs.586.27 & Rs.570.38 per pack vide S.O. 1156(E), 619(E) & 644(E) dated 28.4.2014, 26.02.2015 & 02.3.2016 respectively under NLEM 2011. The ceiling price of Rs.90.454 per 0.1ml for enoxaparin 40mg/0.4ml as well as enoxaparin 60mg/0.6ml, was notified vide S.O. 2963(E) dated 15.9.2016 under para 4, 10, 11 14, 16, 17 & 18 of DPCO 2013 under para 18 of DPCO, 2013, as the NLEM 2011 was substituted by NLEM 2015.

During examination, the DoP noted that the main contentions of the petitioner company are 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, and 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 15.9.2016, 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 petition and may be rejected.

“The issues raised by the petitioner company in the review petition have no merit and hence the review petition is hereby rejected,” the DoP in its order said.