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The Department of Pharmaceuticals (DoP) has rejected Indian pharma major Cipla’s review application against fixing the retail prices of emtricitabine+ tenofovir alafenamide tablet (brand Tafmune – EM) containing emtricitabine IP 200mg, tenofovir alafenamide hemifumarate eq. to tenofovir alafenamide 25mg; tenofovir alafenamide tablet containing tenofovir alafenamide hemifumarate eq. to tenofovir alafenamide 25mg and emtricitabine+tenofovir alafenamide tablet containing emtricitabine IP 200mg, tenofovir alafenamide fumarate hemifumarate eq. to tenofovir alafenamide 10mg tablet.
Cipla had filed the review application on 26.04.2019 under paragraph 31 of the Drug Prices Control Order (DPCO). In the review petition, Cipla contented that the formulation tenofovir alafenamide fumarate (TAF) 25mg tablet cannot be claimed to be therapeutically equivalent to Tenofovir 300mg tablet and thus the ceiling price of tenofovir 300mg tablet cannot be made applicable to the subject formulation. The Experts Committee is required to make recommendations of the retail price as per the principles of ‘Pharmacoeconomics’ in terms of Para 15 of the DPCO. By virtue of SO 1485(E), dated 29th March, 2019, the ceiling price of tenofovir 300mg tablet has been increased by 4.2662% on the basis of the annual increase in Wholesale Price Index (WPI), and has been notified at Rs. 46.18. The benefit of this increase in the ceiling price of tenofovir 25mg by approximately 4% has not been given.
Cipla further contented that with respect to the formulation of emtricitabine IP 200mg tablet and tenofovir alafenamide tablet 10mg, the expert committee has relied on the formula prescribed by the Pronab Sen Committee report which was submitted on September 30, 2005 and as such may not be an accurate indicator of the present times. The company prayed to re-calculate and re-fix the retail prices of the subject formulations after calling for information from all stakeholders.
While examining the petition, DoP which is the reviewing authority noted that the recommendation by the Multidisciplinary Committee of Experts was made on a scientific basis by comparing therapeutic value of one pharmaceutical drug to that of another as per the provisions of the DPCO. Therefore, based on the recommendation of the Multidisciplinary Committee of Experts, the NPPA has rightly extended the price of tenofovir 300mg tablet to TAF 25mg tablet. The Multidisciplinary Committee of Experts recommended the retail price of emtricitabine IP 200mg tablet and tenofovir alafenamide tablet 10mg. based on the principles of “pharmacoeconomics” by applying Pronab Sen Committee formula.
After detailed examination, the DoP came to the conclusion that the NPPA has rightly extended the ceiling price of tenofovir 300mg tablet to tenofovir alafenamide fumarate 25mg tablet on the recommendation of Multidisciplinary Committee of Experts. “There is no valid ground to interfere with the decision of the NPPA on this particular issue. Hence, the plea of applicant on this issue is rejected”, the DoP in its order said.
However, the DoP directed the 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 formulations containing emtricitabine IP 200mg+tenofovir alafenamide hemifumarate eq. to tenofovir alafenamide 25mg; tenofovir alafenamide hemifumarate eq. to tenofovir alafenamide 25mg and emtricitabine IP 200mg+tenofovir alafenamide fumarate hemifumarate eq. to tenofovir alafenamide 10mg tablets of so 1489(e), dated 29.03.2019 accordingly.
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