Emcure plea to direct NPPA to review HIV drugs price junked by DoP

New Delhi: In a setback to drugmaker Emcure Pharmaceuticals, the Department of Pharmaceuticals (DoP) has rejected the company's petition seeking to direct NPPA to revise the retail prices based on the provisions of DPCO, 2013 to ensure just and equitable retail prices to the company's two HIV drug formulations.

The formulations include a combination of Emtricitabine and Tenofovir tablet containing Emtricitabine IP 200mg, Tenofovir Alafenamide Hemifumarate eq. to Tenofovir Alafenamide 25mg; and combination of Dolutegravir, Emtricitabine, Tenofovir Alafenamide tablet containing Dolutegravir Sodium eq to Dolutegravir 50mg., Emtricitabine IP 200mg., Tenofovir Alafenamide Fumarate eq. to Tenofovir Alafenamide 25mg.

The drugmaker submitted Form I applications for the retail price approval of Emtricitabine 200 mg plus Tenofovir Alafenamide 25 mg Tablet (TAF-E) to NPPA on 3rd July 2019 and Dolutegravir 50 mg plus Emtricitabine 200 mg plus Tenofovir Alefenamide 25 mg Tablet (TAF-ED) on 7th May 2019. NPPA has notified the retail price as Rs 51.34/Tab and Rs 130.60/tab, respectively.

Also Read: NPPA Fixes MRP Of 2 Combo Drugs Manufactured By Emcure, Hetero Labs To Prevent HIV; Details

Earlier, the NPPA fixed the retail price of Emtricitabine 200 mg plus Tenofovir Alafenamide 25 mg for Cipla and Mylan Pharmaceuticals at Rs 55.33/tablet based on the recommendation of Multidisciplinary Committee of Experts.

Emcure, in its plea, contended that for the computation of retail price for TAF-E, NPPA used the PTR for the month of April 2019 of Hetero Healthcare Ltd as per PharmaTrac data and the draft working sheet was uploaded on NPPA website on 31.07.2019. However, the company came to know from the minutes of the meeting of 69th Authority meeting of the NPPA that Hetero had not obtained prior price approval, before the launch of the subject formulation and directed for the issue of notice to Hetero for non-compliance to the orders of DPCO. Therefore, their case cannot be compared to the above one as company has followed the 'Rule of Law' as per the existing provisions of DPCO.

The drugmaker further stated that the NPPA has exercised the practice to not to consider the PTR of WPA case in working out the retail price of a formulation in the past also, e.g. Retail Price of Paracetamol 325 mg plus Hyoscine Butylbromide 10 mg tablets (Buscogast Plus Tablets) and the data of German Remedies India Pvt. Ltd. and ACME Pvt. Ltd. were not considered as they were marketing their packs without price approval. The company cited the case of DoP's review order, in case of review filed by Boehringer Ingelheim India Pvt. Ltd. in this regard.

The company added 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 order 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 and Mylan via an order dated 29th March 2019 as PharmaTrac does not show any other brand other than that of Hetero Healthcare.

"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 challenging the S.O. 1489(E) dated. 29th March 2019, wherein the Department has directed NPPA to extend the benefit of 4.2662% increase based on the annual increase in Wholesale Price Index (as given in the ceiling price of scheduled medicine Tenofovir 300mg vide SO 1485(E), dated 29.03.2019 and revise the Retail Prices of the subject formulation," read Emcure's submission.

Responding to the contentions, NPPA stated that the Authority placed the draft version of the price calculation sheet on its website on 31.07.2019 and the minutes of the 12th Meeting of Multi-Disciplinary Committee of Experts in order to take into account the observations from affected pharmaceutical companies before finalizing the retail price of subject formulations.

NPPA further mentioned that Emcure via its letter dated 01.08.2019 stated that they have accepted the retail price proposed in the draft working sheet against their above-said formulations and requested the NPPA to include their form I application in the next Meeting of the Authority so that the price can be fixed at the earliest.

"Since the company has already accepted the retail price; the issue raised by the company in its review application has no merit," NPPA added.

DoP examined the matter and noted that in July 2016, DoP 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 finalize the ceiling and the retail prices. The above decision was taken to maintain transparency and avoid review application by the pharmaceutical firms after the issue of price notification.

Accordingly, the NPPA placed the draft version of price calculation sheets on its website on 31.07.2019. Thereafter, Emcure via its letter 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.

Subsequently, DoP junked the plea stating that since the applicant had conveyed its acceptance to the proposed retail prices in the draft calculation sheets, the retail prices fixed by the NPPA cannot be disputed now. Therefore, the review application is not tenable and deserves to be rejected. DoP held;

The draft version of calculation sheets for the proposed retail price fixation of "Emtricitabine IP 200mg plus Tenofovir Alafenamide 25mg tablet" and "Dolutegravir 50mg plus Emtricitabine 200mg plus Tenofovir Alafenamide 25mg tablet" were placed by the NPPA on its website on 31.07.2019, which was accepted by the applicant on 01.08.2019. The retail prices fixed accordingly, cannot be disputed now. Therefore, the review application is not tenable and stands rejected.

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