New Delhi: Through a recent decision, the Department of Pharmaceuticals (DOP) has rejected the review application filed by Cipla Limited against National Pharmaceutical Pricing Authority (NPPA) for fixing the retail price of Emtricitabine+Tenofovir Alafenamide tablet sold under the brand Tafmune – EM.
Tafmune – EM contains 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.
The product is indicated in the treatment of HIV infection and chronic hepatitis B virus (HBV) infection.
Challenging NPPA’s decision, Cipla contended 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 firm added that 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.
The ceiling price of Tenofovir 300mg tablet has been increased by 4.2662% on the basis of the annual increase in
WPI, and has been notified at Rs. 46.18. However, the benefit of this increase in the ceiling price of Tenofovir 25mg by approximately 4% has not been given.
The firm further mentioned that ith 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 and as such may not be an accurate indicator of the present times.
Cipla in its plea asked to calculate once again and re-fix the retail prices of the subject formulation after calling for information from all stakeholders.
The issue was deliberated in meetings of Multidisciplinary Committee of Experts, represented by very senior Professors and Doctors and other experts in the field, who are capable enough to understand the therapeutic rationale of any drug/formulation.
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. The recommendation was made on a scientific basis by comparing the 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.
It was observed that Cipla failed to give any basis of its contention that the formula, given in 2005, may not be an accurate indicator of the present times. In the instant case, as the formulation is in tablet form, the value of 0.8 is applied, and its application in fixing the retail price of this new drug is in order.
The court further held that the NPPA should have extended the benefit of 4.2662% increase, as given in the ceiling price of scheduled medicine Tenofovir 300mg tablet, based on an annual increase in Wholesale Price Index (WPI), while fixing the retail price of formulation Tenofovir Alfenamide Fumarate 25mg.
Concluding the matter, DOP stated 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 Cipla on this issue is rejected.
“However, the NPPA is directed to extend the benefit of 4.2662% increase based on the annual increase in Wholesale Price Index 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.” the committee noted