New Delhi: The Department of Pharmaceuticals (DoP) has accepted the review petition of Torrent Pharmaceutical against price fixation of formulations “Trilosar 6.25” and “Trilosar 12.5” containing three salts, i.e. Losartan potassium 50mg+Chlorthalidone 6.25 mg+Amlodipine 5 mg, directing National Pharmaceutical Pricing Authority (NPPA) to revise the ceiling price of the same.
DoP has ordered NPPA to refix the ceiling prices of the drugs by giving the impact of wholesale price index (WPI) for the subsequent years to the retail prices being considered of earlier years and arrive at a reasonable current base price for the combinations Losartan Potassium 50mg+Chlorthalidone 6.25mg and Losartan Potassium 50mg+Chlorthalidone 12.5mg and by considering the prevalent ceiling price of scheduled formulation Amlodipine 5 mg.
Trilosar prevents the blood vessels in your body from narrowing, thus lowering your blood pressure and improving the blood circulation. This medication has the ability to lower the possible risk of a stroke in people suffering from any heart condition. Apart from that, it can also slow down kidney damage among people with type 2 diabetes.
Torrent Pharma in its review petition contended that NPPA notified retail price of formulation Trilosar 6.25, containing three salts, i.e. Losartan potassium 50mg+Chlorthalidone 6.25 mg+Amlodipine 5 mg vide 5638(E) dated 02.11.2018.
However, regarding Losartan Potassium 50mg and Chlorthalidone 6.25 mg, NPPA considered retail price Rs 4.50 which was notified vide SO 583(E) dated 24.02.2016 for Cadila Pharmaceuticals Limited. Since this is a non scheduled combination, NPPA should have taken a price increase of 10% per year as per para 20 of DPCO to arrive at the current price of subject formulations.
Similarly, for the formulation Trilosar 12.5, NPPA has considered retail price of Rs 4.55 for salts Losartan Potassium 50mg+Chlorthalidone 12.5 mg which was notified vide SO 3146(E) dated 10.12.2014 for Cadila Pharmaceuticals Limited, without considering price increase of 10% per year as per para 20 of DPCO to arrive at current price of subject formulations.
While calculating the retail price for 2015 for a formulation of another company, NPPA, in one of its meeting held on 25.5.2018 has taken a reference price of 2009 and taken increase @ 10% year on year for 6 years (2009 to 2015) to arrive at the price of 2015.
The company further alleged that for arriving at the retail price of both the above formulations, NPPA has taken a base of Rs 2.33 per tablet for salt “Amlodipine 5 mg” (which is a scheduled formulation), notified vide SO 1686(E) dated 09.05.2016. However, NPPA has not taken Wholesale Price Index announced in April 2017 for the year 2016 and announced in April 2018 for the year 2017 to arrive the price of the subject formulation.
The applicant conteded that NPPA should have considered Rs 2.45 base price for Amlodipine which was notified vide SO 1461(E) dated 02.04.2018. 2.4 Moreover, for both the drugs, NPPA has taken a reduction of 20% on the price of Rs 2.33, being a lower price in comparison with the price of Losartan+Clorthalidone.
Since actual notified prices are considered as a base for notifying retail price of their formulations, there was no need to reduce the price by 20%.
However, the NPPA contended that the retail prices of both the formulations have been correctly notified with the approval of Authority, as per para 5 and para 15 of DPCO considering the recommendations 4th Meeting of Multidisciplinary Committee of Expert held on 27.09.2018.
During the examination, the DoP stated that in order to arrive at the reasonable current base price for both the strengths/ combinations, the impact of wholesale price index should be given for subsequent years to the retail price of Rs 4.50 per tablet notified in 2016 for combination of nonscheduled medicines (Losartan Potassium 50mg and Chlorthalidone 6.25 mg) and Rs 4.55 for Losartan Potassium 50mg and Chlorthalidone 12.5 mg notified in 2014. For scheduled formulation Amlodipine 5 mg, the prevalent ceiling price should be considered.
Giving the decision, DoP directed the NPPA to refix the retail prices of Trilosar 6.25 and Trilosar 12.5.