Department of Pharmaceuticals rejected Cipla's plea for Emtricitabine and Tenofovir combination

  • Posted on: 13 September 2019
  • By: PharmaTutor News

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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.

Department of Pharmaceuticals (DoP) has rejected Cipla's plea against decision of National Pharmaceutical Pricing Authority (NPPA) for fixing the retail prices of Emtricitabine+ Tenofovir Alafenamide tablet (brand Tafmune - EM) containing Emtricitabine IP 200mg, Tenofovir Alafenamide Hemifumarate eq. to Tenofovir Alafenamide 25mg.

Cipla made an application to DoP on 26th April 2019 after NPPA's notification on 29th March 2019 about fixing prices of Emtricitabine+ Tenofovir Alafenamide tablet.

 

In that plea Cipla suggested 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 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 to them.

The NPPA’s Authority fixed the retail price of Tenofovir Alfenamide Fumarate 25mg and Tenofovir Alfenamide Fumarate 25mg+ Emtricitabine 200mg tablet based on the recommendation of Multidisciplinary Committee of Experts in its 8th Meeting held on 18th March, 2019. While making the recommendation, the Multidisciplinary Committee of Experts has gone through all the technical matters submitted by the company.

The issues relating to incremental innovation in the formulations, therapeutic rationale and other related issues, were deliberated in-depth in the 6th, 7th and 8th meetings of Multidisciplinary Committee of Experts. The representations of Pharma companies manufacturing TAF were also considered by the Expert Committee. The Expert Committee is well 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 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 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, 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 (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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