|
The Department of Pharmaceutical (DoP) has rejected the review application filed by Emcure Pharmaceuticals Ltd against the notification S.O. No.3032(E), dated 23.08.2019 issued by the NPPA fixing the retail prices of emtricitabine+ tenofovir tablet containing emtricitabine IP 200mg, tenofovir alafenamide hemifumarate eq. to tenofovir alafenamide 25mg and dolutegravir + emtricitabine +tenofovir alafenamide tablet containing dolutegravir sodium eq to dolutegravir 50mg, emtricitabine iP 200mg, tenofovir alafenamide fumarate eq. to tenofovir alafenamide 25mg.
The applicant Emcure had submitted form I application for the retail price approval of emtricitabine 200 mg plus tenofovir alafenamide 25 mg tablet (TAF-E) to NPPA on July 3, 2019 and dolutegravir 50 mg plus emtricitabine 200 mg plus tenofovir alefenamide 25 mg tablet (TAF-ED) on May 7, 2019.
But the review application was disposed of by the DoP in its review application dated on 23.08.2019.
In its review petition the company stated that earlier NPPA has fixed the retail price of emtricitabine 200 mg plus tenofovir alafenamide 25 mg for Cipla Ltd. and Mylan Pharmaceuticals Pvt. Ltd. vide S.O. 1489(E) dated. 29th March, 2019 at 55.33/tablet based on the recommendation of multidisciplinary committee of experts in its 8th meeting held on 18.3.2019.
The company further stated that the NPPA has considered the PTR of April 2019 instead of November 2018 for retail price fixation considering the amendment in para 9(7) vide DoP’s S.O. 39(E) issued by the department dated 3rd January 2019. However, NPPA has ignored the fact that the same methodology can only be considered for fixing the ceiling price and not the retail price. The retail price should have been fixed by extending the retail price of emtricitabine 200 mg plus tenofovir alafenamide 25 mg fixed for Cipla Ltd and Mylan Pharmaceuticals vide S.O. 1489(E) dated 29th March, 2019 as PharmaTrac does not show any other brand other than that of Hetero Healthcare Ltd.
The NPPA has not extended the benefit of 4.2662% increase based on the annual increase in wholesale price index (WPI). In this regard, the company cited the decision vide DoP’s review order (No.31015/10/2019-Pricing) on a review application filed by Cipla Ltd challenging the S.O. 1489(E) dated. 29th March, 2019, where in the department has directed NPPA to extend the benefit of 4.2662% increase based on the annual increase in WPI (as given in the ceiling price of scheduled medicine tenofovir 300mg vide S.O.1485(E), dated 29.03.2019 and revise the retail prices of subject formulation.
During the examination of the case, the DoP noted that the DoP vide OM No.31015/44/2016-PI.I, dated 11th July, 2016 had directed the NPPA to place a draft version of the price calculation sheets for the proposed price notifications, indicating the price to retailer (PTR) and moving annual turnover (MAT) values adopted for calculations. wherever application, on the website of the NPPA for 10 clear working days to invite comments from the affected pharmaceutical firms. Only after taking into account the comments of any additional data thus received within the given time period, the NPPA shall finalise the ceiling and the retail prices. The above decision was taken to maintain transparency and avoid review application by the pharmaceutical firms after issue of price notification.
Further noted that the NPPA has placed the draft version of price calculation sheets on its website on 31.07.2019. Thereafter, the company, viz. Emcure Pharmaceuticals Limited, vide its letter no EPL/NPPA/141 dated 01.08.2019 accepted the retail prices proposed in the draft working sheets against its above said formulations and requested the NPPA to include their form I application in the next meeting of the authority so that the prices can be fixed at the earliest. Thereafter, the price notification was issued by the NPPA on 23.08.2019.
“The review application of Emcure Pharmaceutical is devoid of merit and is therefore rejected”, the DoP in its order dated January 10, 2020 said.
|