The Department of Pharmaceuticals (DoP) has directed the national drug regulator National Pharmaceutical Pricing Authority (NPPA) to revalidate data on Cefotaxime 250 mg and 500 mg injections for reviewing the ceiling prices of the same. The DoP's order in this regard came on a review petition filed by Alkem Laboratories Ltd against fixation/revision of ceiling prices of  Cefotaxime 250 mg and 500 mg injections by the NPPA.

The NPPA vide price fixation Order S.O. No.2350(E) dated 15/9/2014 had fixed/revised ceiling price of Cefotaxime 250 mg and 500 mg under DPCO, 2013, included in section 6.2.1.4 in schedule-I of the DPCO.

Aggrieved by the NPPA notification, the petitioner Alkem Laboratories submitted a review application with the reviewing authority DoP dated 13.10.2014 under para.31 of DPCO, 2013 for the review of NPPA price fixation Order S.O.No.2350 (E) dated 15.9.2014 fixing ceiling price of Cefotaxime 250 mg and 500 mg under DPCO, 2013.

In the review petition, the petitioner mentioned that the PTR taken by NPPA in their calculation sheet is not correct for their company. There may be similar discrepancies in other cases also. The discrepancies noted by the company is that after the PTR of Rs. 12.35 NPPA had not taken a WPI of 7.54 per cent due for the year 2012 to be availed by the company in 2013 under para 10 of DPCO 2013. IMS Health has not revised the data after the company had availed WPI under para 10. The petitioner mentioned that their PTR after including latex free rubber stopper is Rs. 13.55 for 250 mg and Rs. 17.60 for 500 mg.

In reply, the NPPA commented that it had taken the data as provided by IMS Health. IMS had mentioned PTR of Alkem as Rs. 12.92 (250 mg) and Rs. 16.42 (500 mg) but the same was restricted to derived PTR of Rs. 12.35(250 mg) and Rs.16.29(500 mg) worked out on the basis of DPCO 1995 ceiling vide SO 1612 (E) dt. 19.7.12. In working out derived PTR the WPI of 7.54 per cent has not been considered since availing of WPI depends on decision of the company and cannot be assumed to be availed by all the companies. PTR given by IMS is lower than the PTR claimed by the petitioner.

After hearing both the parties, the reviewing authority DoP ordered, “NPPA may be directed to revalidate the data as empowered under para 9(1) of DPCO 2013, after the companies have availed WPI 2012 allowable in 2013 strictly as per the provisions contained in para 10 of DPCO 2013.  Derived prices are not provided under DPCO 2013 and therefore cannot be applied.”