NPPA revises retail price of Emcure Pharma Darunavir, Ritonavir FDC

The matter pertains to a review order issued by the department on 25 June 2021 directing the National Pharmaceutical Pricing Authority (NPPA) to fix the retail price of the formulation Darunavir 800 mg + Ritonavir IP 100 mg for Emcure Pharmaceuticals Limited strictly as per provisions of para 5(1) read with para 9(4) of DPCO, 2013 and consider the PTR of available drugs in the market, take simple average of all those who have more than 1% market share and consider the fixation of drug price as per the simple average formula contained in para 4(1) of DPCO, 2013.

In response, NPPA had informed that the matter was deliberated in the 91st meeting of the Authority held in July 2021 and it was noted that:

" Emcure Pharmaceuticals Limited had applied for retail price fixation of Darunavir 800 mg + Ritonavir 100 mg tablet in the month of June, 2019. As per the provisions of DPCO, 2013, the data of six months earlier than the month of receipt of the application was to be considered for calculation of retail price i.e. November 2018) under Para 9(4J of DPCO, 2013. From analysis of latest Pharmatrac data available at that time, it was noted that the data for the month of November, 2018 was not available. Further, the market based data of Darunavir 800 mg + Ritonavir 100 mg tablet was not even available for twelve months before November 2018 in AIOCD-AWACS Pharmatrac database. Hence, the matter was referred to Multi-Disciplinary Committee of experts. The Multidisciplinary Committee of(Experts in its 13th meeting recommended the retail prices of each film coated tablet contained Darunavir 800 mg + Ritonavir100 mg of Emcure Ltd, (marketer) and Hetero Labs Ltd., (manufacturer/lmporter) at Rs. 197.55 per tablet excluding GST based on the midst PTO ss submitted by Hetero Healthcare Ltd in Form-V. The Authority noted that the price had been recommended based on Form V data which is in line with the data as per Pare 9(2) o/ DPCO, 2013. Hence, the Authority in its 70th meeting dated 20.10.2019 fixed the retail price based on the recommendation of Multidisciplinary Committee of Experts."

The Authority had deliberated upon the matter in detail and observed that since the data is not available, the retail price could not be calculated as per Para 5(1) read with para 9(4) of D PCO 2013 towards implementation of the review order. Accordingly, the had Authority decided to refer the matter to DoP.

"In view of the above, since the data is not available, the retail price could not be calculated as per Para 5(1) read with para 9(4) of DPCO 2013 towards implementation of the review order. Accordingly, NPPA referred the matter to the Department of Pharmaceuticals (DoP) for further direction," NPPA had stated.

Also Read: Setback To Emcure: NPPA Refers Back Price Fixation Issue Of Darunavir, Ritonavir FDC To DoP

In light of the foregoing, the matter was re-considered in the Department and it was noted;

" in the 70th Authority meeting of NPPA, no consistency was made. While in the case of formulation 'Dolutegravir-50 mg, Lamivudine 300mg, Tenofovir Disoproxil Fumarate 300mg' the retail price notified on 02.11.2018 for Mylan and Emcure, based on the recommendation of MDC held on 27.09.2018, was passed on to the subsequent applicant, viz. Cipla almost after a gap of one year, without referring again to MDC. Whereas, the retail price of Darunavir 800 mg+ Ritonavir 100 mg, which was already fixed on 2nd November, 2018 for Hetero Healthcare Limited based on recommendations of the MDC held on 27th September, 2018, but the application of Emcure for the same product was again referred to the MDC for consideration in its meeting held on in September, 2019 and price fixed as per recommendations of MDC dated 24.09.2019."

Based on the observations made above, NPPA was asked in April, 2022 to re-consider the matter so as to maintain uniformity and consistency in considering cases of similar nature and specifically those which were considered in the same meeting of the authority. Limiting the scope of the instant Order, it was clarified that the said decision will, however, be standalone and not act as a precedent in other cases, where the NPPA might have taken action(s) on merit of such cases, as appropriate.

Subsequently, the price of the formulation was revised as mentioned by DoP in its review order dated October 4, 2022;

"NPPA has since revised the price of the formulation under consideration of Emcure Limited vide their price Notification dated 9th May 2022 fixing Price of Darunavir 800mg + Ritonavir IP 100mg as Rs. 212.91 per tablet."

It further concluded that;

"Review order dated 25 June, 2021 accordingly stands modified to the extent as indicated above."