DOP Order: NPPA refixes retail price of Trilosar 6.25, 12.5

New Delhi: Through a recent notification, the government regulatory agency, the National Pharmaceutical Pricing Authority (NPPA) has fixed the retail price of 2 drug formulations namely Losartan + Chlorthalidone + Amlodipine Tablet (TRILOSAR 6.25 ) and Losartan + Chlorthalidone + Amlodipine Tablet (TRILOSAR 12.50)

The move comes in with the directions given by the Department of Pharmaceuticals (DoP) in consideration of the review orders filed by Torrent Pharma and Unichem Labs to refix the price of Trilosar.

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.

Medical Dialogues had earlier reported that the Department of Pharmaceuticals (DoP) had accepted the review petition of Torrent Pharmaceutical and Unichem Laboratories 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.

Also Read: Refix Ceiling Price of Torrent pharma Trilosar 6.25, 12.5 : DoP directs NPPA

The companies had alleged that for arriving at the retail price of both the above formulations, NPPA had 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 had 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 applicants had contended 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 had taken a reduction of 20% on the price of Rs 2.33, being a lower price in comparison with the price of Losartan+Clorthalidone.

After detailed deliberation of the matter, DoP directed the NPPA to refix the retail prices of Trilosar 6.25 and Trilosar 12.5.

Following DoP's order, NPPA has now fixed the retail price for the said drugs. The details of the drug reads;

The notice further adds;

• The manufacturer of above mentioned formulations i.e. "new drug" under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table


• The manufacturer may add goods and services tax only if they have paid actually or it is payable to the Government on the retail price mentioned in column (5) of the above said


• The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and


• As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the


• The above mentioned retail prices are applicable only to the manufacturer / marketer as mentioned above for generic/ any brand of the same composition / strength of the subject formulations, subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies.


• In case the retail price of any of the aforesaid formulations is not complied with, as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act,