The Department of Pharmaceuticals (DoP) has directed the National Pharmaceutical Pricing Authority (NPPA) to refix the ceiling price for phenobarbitone 30 mg tablet and examine the documents submitted by the petitioner company on merit, and refix/revise the price of sodium valprorate 200 mg tablets, if necessary.

Earlier, Abbott Healthcare Pvt Limited had filed review applications against price fixation of their formulations “Phenobarbitone 30 mg and sodium valprorate 200 mg tablets” vide NPPA order No. S.O. 2193(E) [corrected SO No.2195)] dated 23.06.2016 issued under DPCO 2013.

For phenobarbitone 30 mg, the petitioner contended that the NPPA had notified upward revision of ceiling price for phenobarbitone 30 mg on 24.02.2016 vide notification no. SO 582(E) as INR 1.63 &SO 644(E) dt. 02.03.2016 as Rs. 1.59 towards negative WPI reduction. The subject correction in Feb’16 was a result of the review hearing which was filed by us challenging the ceiling price calculation of S.O 1877(E) dated 28.06.2013 & S.O 1785(E) dated 10.07.2014 and finally after a long waiting, NPPA had acknowledged the error and awarded the relief in Feb’16. Hence, based on the Feb’16 ceiling price notification, which overrides the Jun’13/July’14 NPPA notifications, the PTR works out to be Rs. 1.29 per tablet. Hence applying MAT Aug’15 PTR while refixing ceiling prices in Jun’16, is prone to error due to incorrect base being referred. Hence, for the calculation purpose, NPPA needs to consider PTR as Rs. 1.29 per tablet which was recently notified by NPPA after factoring negative WPI.

For sodium valprorate 200 mg tablets, the petitioner contended that there are few calculation errors in the working sheet published by NPPA on 28th June 2016. Here NPPA has considered the PTR for Epilex 200mg Tablets 15’s as Rs. 1.74 per tab whereas they had stopped manufacturing & marketing of Epilex 200mg Tablets 15’s pack since year 2011. Meanwhile, despite the error in calculation, they have implemented the ceiling price as per NPPA Notification No. SO 2193(E) {corrected S.O. No. 2195(E)} dated 23.06.2016 for their formulations.

During the examination, DoP noted that the company’s grievance is that NPPA took the MAT August,2015 PTR while fixing ceiling price in June, 2016, instead of taking the revised ceiling price granted to them in February/March, 2016. Hence, the contention of the petitioner company that taking MAT August, 2015 PTR and ignoring February/March, 2016 price fixation by NPPA, while fixing ceiling price in June, 2016 has got merit. Therefore, NPPA may be directed to reconsider the fixation of ceiling price for phenobarbitone 30 mg. tablet.

As regards, sodium valprorate, company stated that the manufacturing & marketing of Epilex 200mg Tablets 15’s pack have been stopped since year 2011 and also submitted CA certificate to this effect. Further, NPPA considered Epilex 200 mg Tablets 10’s PTR as Rs. 2.61 per tab, whereas actual PTR should be Rs. 2.71 per tab. In support, the company submitted scanned copy of carton during personal hearing. Keeping in view the documents submitted by the company, NPPA may be directed to examine the documents submitted by the petitioner company on merit, and refix/revise the price of sodium valprorate, if necessary.

After detailed examination, the DoP ordered, “NPPA is hereby directed to refix the ceiling price for phenobarbitone 30 mg. tablet using revised prices. NPPA is also directed to examine the documents submitted by the petitioner company on merit, and refix/revise the price of sodium valprorate, if necessary”.