DoP directs NPPA to re-fix ceiling price of Propanolol 40mg tablets

Mumbai, November, 2016

The Department of Pharmaceuticals (DoP) has directed the National Pharmaceutical Pricing Authority (NPPA) to re-fix the ceiling price of Propanolol 40mg tablets. The DoP's order in this regard came after examining the review application filed by Abbott Healthcare Pvt. Ltd against price fixation of “Propanolol 40 mg tablets” by the NPPA.

 

The NPPA vide its order No. S.O. 1351(E)[corrected SO No.1951(E)] dated 02.06.2016 had earlier fixed the ceiling prices of “Propanolol 40 mg tablets” under Drugs (Prices Control) Order, 2013 (DPCO 2013). Aggrieved by the NPPA order, Abbott Healthcare filed the review application against price fixation of “Propanolol 40 mg tablets” by the NPPA.

 

In its review application, the petitioner contended that there are few calculation errors in the working sheet published by NPPA. They have revised the calculation and as per their calculation the revised ceiling price should be Rs.2.86 per tablet. Further, it contended that Ciplar LA 40mg tablets 15’ is not considered in working sheet. The details extracted from AIOCDAWACS data was also appended. The petitioner asked the DoP to advise NPPA to clean up Pharma Trac data to reflect the correct position. Considering these facts, the petitioner requested the department to revise the ceiling price of propanolol 40mg tablets.

 

In reply, the NPPA commented that it has fixed the ceiling price of Rs.2.56/tablet for propanolol 40mg Tablet vide S.O. 2528(E) dated 21.8.2013 and the same was revised to Rs.2.72, Rs.2.82 & Rs.2.47 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 for this pack was fixed at Rs.2.59/tablet vide S.O. 1351(E) dated 02.6.2016 under NLEM 2015 as per Data provided by Pharma Trac for August, 2015. Concerned companies, viz. Cipla and Surien Pharmaceuticals Pvt. Ltd have not raised any issue or submitted any representation to NPPA. Company has submitted Form-V through IPDMS. On scrutinizing latest data reporting by company it could not ascertain the company has complied ceiling price based on S.O. 1951(E) dated 02.06.2016.

 

During the personal hearing, the representative of the company aggrieved by the notification, requested to advise NPPA to revise the ceiling price of propanolol 40 mg after including the data/details of Ciplar LA 40 MG tablet 15’s of Cipla Ltd. as the published working for propanalol 40 mg does not have Ciplar LA 40 mg tablet 15’s of Cipla Ltd. NPPA representative stated that NPPA has fixed the ceiling price based on the data submitted by Pharma Trac for the period of August, 2015 and no representation of Cipla is pending with NPPA in regard to Ciplar LA 40 mg tablet.

 

During examination, the DoP noted that the petitioner company has contended that there are few calculation errors in the working sheet published by NPPA. The petitioner company has revised the calculation and as per their calculation the revised ceiling price should be Rs.2.86 per tab. The company also contended that Ciplar LA 40mg Tablets 15’ is not considered in working sheet and submitted the details extracted from AIOCD- AWACS data. The company requested this department to advise NPPA to clean up Pharma Trac data to reflect the correct position and also requested this department to revise the ceiling price of propanolol 40mg tablets. NPPA appears to have erred in considering the data and may be directed to examine the data furnished by the petitioner company on merit along with other relevant data/information and to re-fix the price of the product of the petitioner company within one month of the decision in this regard.

 

After examining the issue, the DoP ordered, “NPPA is hereby directed to examine all the relevant data/information furnished by the petitioner company again on merits and to re-fix the ceiling price of propanolol 40mg tablets”. Pharmabiz