Setback to Emcure: NPPA refers back price fixation issue of Darunavir, Ritonavir FDC to DoP

This came in line with the review order directed by the Departmental of Pharmaceuticals wherein NPPA was directed to "fix the retail price of the formulation Darunavir 800 mg + Ritonavir IP JOO mg for Emcure Pharmaceuticals Limited strictly as per the provisions of para 5 (1) read with para 9 (4) of DPCO, 2013 and consider the PTR of available drugs in the market, taking a simple average of all those who have more than 1% market share and considering the fixation of drug price as per the simple average formula contained in para 4(1) of DPCO, 2013."

The FDC medicine 'Darunavir+Ritonavir' is an anti-retroviral medication used to treat human immunodeficiency virus (HIV-1) in adult patients who have already received therapy. Darunavir is a human immunodeficiency virus type 1 (HIV-1) protease nonpeptidic inhibitor, with activity against HIV. Upon oral administration, darunavir selectively targets and binds to the active site of HIV-1 protease, and inhibits the dimerization and catalytic activity of HIV-1 protease.

Ritonavir is an antiretroviral protease inhibitor that is widely used in combination with other protease inhibitors in the therapy and prevention of human immunodeficiency virus (HIV) infection and the acquired immunodeficiency syndrome (AIDS).Darunavir and ritonavir are taken in combination as ritonavir increases the concentration of darunavir and hence its effectiveness.

Earlier, the Medical Dialogues team had reported that in its application, Emcure had stated that on November 8, 2019, the company was granted a retail price of Rs. 197.55/tab for Darunavir 800 mg+ Ritonavir 100 mg, whereas Hetero Healthcare Ltd was granted a different retail price of Rs. 212.91/tab on November 2, 2018. As a result, the retail price was reduced by Rs 15.36 per tab.

However, in response to the above claim, the NPPA stated, "the retail price of Rs 212.91 per tablet was notified to M/s Hetero Healthcare Limited. However, the PTR of Hetero Healthcare Ltd was found to be Rs. 170.30 per tablet from Form-V. As per provisions of DPCO, 2013, a 16 % margin is added with PTR to arrive at the ceiling/retail price. Accordingly, by taking the PTR of M/ s Hetero Healthcare Ltd as per Form-V, the retail price comes to Rs 197.55 per tablet excluding GST (Rs 170.30 X 1.16 = Rs 197.55). "

NPPA further contended that Emcure provided Form-V dated December 5, 2019, in which the firm indicated that it obeyed the Retail Price set by NPPA in SO 4062 (E) dated November 8, 2019. The firm, on the other hand, did not include "effective batch No. & date" in the form V that was filed.

Thereafter, at the 223rd meeting of the Authority (overall), which is the 91st meeting under the DPCO, 2013, held on the 29th of July 2021 under the Chairmanship of Shubhra Singh, the authority again deliberated on the matter regarding the review application of Emcure Pharm against retail price fixation of Darunavir 800mg + Ritonavir 100 mg tablet vide S.O. 4062 (E) dated 08.11.2019, in accordance with the review order directed by the Department of Pharmaceuticals.

In the recent authority meeting, the authority noted that Emcure Pharma 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 the calculation of retail price (i.e. November 2018) under Para 9 (4) of DPCO 2013." the authority added.

Further, it was noted from analysis of the latest Pharmatrac data available at that time, 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 the AIOCD-AWACS Pharmatrac database.

Hence, the authority held that the matter was referred to the Multidisciplinary Committee of experts and the Multidisciplinary Committee of Experts in its 13th meeting recommended the retail price of each film coated tablet containing Darunavir 800 mg + Ritonavir 100 mg for Emcure Ltd. (marketer) and Hetero Labs Ltd. (manufacturer/Importer) at Rs. 197.55 per tablet excluding GST based on the latest Price to Retailer (PTR) as submitted by M/s Hetero Healthcare Ltd in Form ­V.

Furthermore, the Authority observed that the retail price suggested by the Multidisciplinary Committee of Experts was based on Forrn-V data, which is consistent with the data set out in Paragraph 9 (2) of the DPCO 2013. As a consequence, during its 70th meeting on October 20, 2019, the Authority decided on the retail price based on the proposal of the Multidisciplinary Committee of Experts.

Following extensive consideration, the NPPA authorities concluded,

"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, the Authority decided to refer the matter to DoP."