Acting on a review application filed by Abbott India against the fixation/revision of ceiling prices of ibuprofen 200 mg and 400 mg tablets, the reviewing authority, department of pharmaceuticals (DoP) has directed the national drug price regulator National Pharmaceutical Pricing Authority (NPPA) to revise the prices of ibuprofen 200 mg and 400 mg tablets.
The NPPA vide price fixation Order S.O. No. 1202(E) dt. 6.5.2015 had fixed/revised ceiling price of “Ibuprofen 200 mg and 400 mg tablet” under DPCO, 2013 included in section 27.08.1 in Schedule-I of the order. Aggrieved by the order, Abbott submitted a review application dated 18.5.2015 under para.31 of DPCO, 2013 for the review of NPPA price fixation Order.
In its review application, the petitioner argued that ibuprofen 200 mg and 400 mg were fixed on 20.12.2013 on the basis of their review application. As per the provisions of DPCO 2013 the price of the formulations which are covered under para 10 the price of their formulations were freezed for one year and, thereafter they were allowed a WPI increase on 20.12.2014 which they have availed. However while fixing the ceiling price vide notification 1202(E) dt. 6.5.2015 NPPA did not take into account the WPI taken by the petitioner on 20.12.2013. They have, therefore, requested for revising the price notification notified vide notification 1202(E) dt. 6.5.2015.
In reply, the NPPA stated that para 9 of DPCO 2013 specifies the reference data and source of market based data. The reference data for new drug has been stated to be 6 months before the receipt of application for new drug. In case of first time introduced formulations under DPCO 2013 the reference data of May 2012 has been specified under DPCO 2013 which is 6 months before the date of announcement of National Pharmaceuticals Pricing Policy 2012. In case of revision in first schedule reference date 2 would be 6 months before the date of notification of revision of first schedule. Para 9(6) states that the reference date for the common formulations shall be as per provision of para 10 of DPCO 2013. However, reference date relevant to reference data has not been specified in para 10. In a nutshell, there must be a reference date/data to be considered for price fixation.
After hearing both the parties, the DoP stated that the NPPA has erred in considering the data pertaining to 6 months before i.e. September 30 of the previous year by which they have ignored the WPI availed by the petitioner under para 10(2) quoted above. NPPA is also not correct in presuming that two WPI cannot be given in one year. DPCO, 2013 under para 9(6) and 10(2) contains special provision of WPI for common formulations under both DPCO 1995 and DPCO 2013 i.e. first after one year of cooling and second in the beginning of the next financial year. Moreover in the instant case the WPI availed by the petitioner in December 2014 after one year of the notification date and second on April 1, 2015 i.e in the next financial year. Therefore the point of two WPI in one year by NPPA has no merit.
“NPPA may be directed to revise the prices of the subject formulations after the petitioner had availed WPI in December 2014 as per provisions of para 9(6) and 10(2) of DPCO 2013. The petitioner will be entitled for WPI again w.e.f. 1.4.2015,” the DoP ordered.