New Delhi : Bringing a two and a half year old dispute by the Pune-based Emcure Pharmaceuticals related to the price fixation of its HIV drug combination to a closure, the National Pharmaceutical Pricing Authority (NPPA) has revised the retail price of the same on par with the price it has fixed earlier for another manufacturer. The drug price regulator has also fixed the retail price of 84 drug formulations including anti-diabetic combinations of sitagliptin, linagliptin and others.
According to the latest notification of NPPA, the price of each darunavir ethanolate equivalent to Darunavir 800 mg and Ritonavir IP 100 mg tablet manufactured by Hetero Labs Ltd and marketed by Emcure Pharmaceuticals, will be Rs. 212.91. The decision was taken after multiple correspondence between the Authority and the Department of Pharmaceuticals (DoP), starting with the latter issuing a review order on June 25, 2021.
Emcure Pharma, in a review application filed with the DoP in December 1, 2019, said that the NPPA has fixed the retail price of Darunavir 800 mg + Ritonavir IP 100 mg, as Rs. 197.55 per tablet, through an notification in November 8, 2019, while the same combination of Hetero Healthcare Ltd in November 2, 2018 was fixed at Rs. 212.91 per tablet based on the recommendation of the multidisciplinary committee (MDC) of experts.
The company alleged that its application was referred to the MDC and the retail price was fixed as per the recommendation of the committee, resulting in a delay of four months, while the retail price declared earlier for Hetero Healthcare should have been extended to them as per the existing practice of NPPA. This also allowed NPPA to deviate from its current approach on retail price fixation.
Besides, it pointed out that in other similar cases where the subsequent applicants have been passed on the same retail price as was recommended to the first applicant based on the recommendation of MDC, such as the retail price of a combination drug for both Cipla and Mylan & Emcure, almost in a gap of one year.
Mylan & Emcure got the price fixed in November 2018 based on the MDC recommendation, while the same was passed on to Cipla in November 2019, even though the Price to Retailer (PTR) was available in January 2019, in the AIOCD-AWACS PharmaTrac data. The price available in the data was lower than the price fixed for Cipla later, it said.
It alleged that NPPA has applied two different principles for similar cases. The NPPA relied on the PTR from Form V submitted by Hetero earlier to fix the retail price of its combination. In case PTR was not available from PharmaTrac, from where the Authority uses the data at present, the retail price granted earlier should have been passed on to them, which is the practice the Authority has been claiming all along since the promulgation of DPCO, 2013 in May 2013.
NPPA, in response to Emcure’s review application with the DoP, said that the price of the combination for Emcure Ltd, which is the marketer and Hetero Labs, which is the manufacturer or importer, at Rs. 197.55 per tablet excluding GST based on the latest PTR submitted by Hetero Healthcare Ltd in Form V, where the PTR was found to be Rs. 170.30 per tablet. The retail price arrived at Rs. 197.55 per tablet, by adding a 16 per cent margin.
DoP, in its order on June 25, 2021, observed that the NPPA could have used the retail price of Rs. 212.91 per tablet for Hetero Healthcare, while filing the retail price for Emcure Pharmaceuticals. It noted that as per provisions in DPCO for calculation of retail price of new drugs for existing manufacturers of scheduled formulations Para 5(1) and Para 9(4) has to be followed.
The 223rd meeting of the Authority held on July 29, 2021, 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 DPCO 2013 towards implementation of the review order. “Accordingly, the Authority decided to refer the matter to DoP,” said the Authority.
The latest of the correspondence between the DoP and the NPPA was on April 5, 2022, following which the pricing authority in its last meeting finalised the revision of the pricing. The new retail price was notified by the Authority on May 9, 2022.
Based on the decision taken in the 97th Authority meeting held on May 6, 2022, it has notified the retail prices for 84 drugs including linagliptin and metformin hydrochloride tablets, vildagliptin and metformin hydrochloride tablets, sitagliptin phosphate and metformin hydrochloride tablets, among others from various Indian manufacturers.