NPPA told to revise prices of 3 Sun Pharma Formulations

New Delhi: Through a recent order, the Department of Pharmaceutical has directed the NPPA to revise the prices of 3 Sun Pharma formulations, after the company reached the DOP challenging the NPPA price fixation. The company contended that NPPA while arriving at the price of said formulations had additionally included GST which needed to by accounted for.

It is reported that an application was filed on 10.7.2018 under paragraph 31 of the Drugs (Prices Control) Order, 2013 (hereinafter called the DPCO) by M/s Sun Pharma Laboratories Limited (hereinafter called the applicant) against notification S.O. No.2398(E), dated 12.06.2018 issued by the National Pharmaceutical Pricing Authority (hereinafter called the NPPA) fixing the ceiling prices of Triolmezest CH 20 tablets (containing Olmesartan IP 20mg+Amlodipine Besylate IP eq. to Amlodipine 5mg+Chlorthalidone IP 12.5mg) and Triolmezest CH 40 tablets (containing Olmesartan IP 40mg+Amlodipine Besylate IP eq. to Amlodipine 5mg+Chlorthalidone IP 12.5mg).

M/s Sun Pharmaceutical Industries Limited also filed review application dated 10.07.2018 on the similar issue in respect of its formulation Rosuvas CV 10 (containing Rosuvastatin calcium eq. to Rosuvastatin 10mg+Clopidogrel Bisulphate eq. to Clopidogrel 75mg). Since the substantial issue and arguments raised by both the companies are same, the review applications of both the companies are disposed of by this order.

2. The companies have contended as under:-

a) M/s Sun Pharma Laboratories Limited: Retail price for Triolmezest CH 20 tablets, Triolmezest CH 40 tablets were notified as Rs. 8.78/- per tablet and 15.53/- per tablet respectively vide NPPA SO 2398(E) dated 12.06.2018.

Working sheet for this notification was made available on NPPA website only on 25.06.2018. Company could get to know about this calculation anomaly though this working sheet only. It is evident from working sheet that the market data of July 2017 were used in retail price computation. Additionally a factor of 0.95905 was incorporated in arriving final retail price as Rs. 8.78/- per tablet for Triolmezest CH 20, and as 15.53/- per tablet for Triolmezest CH 40. It is pertinent to note that GST rate was made effective from 01.07.2017 and in captioned retail price computation market data of July 2017 was considered wherein already post GST PTR were appearing. However, in instant case GST rate was factored additionally @ 0.95905% in the calculation which appears to be erroneous, details of which are mentioned below:

Product	Retail Price based on July 2017 data (Per Tablet)	Final retail price by factoring 0.95905 (Per Tablet)
Triolmezest CH 20	Rs. 9.15	Rs. 8.78
Triolmezest CH 40	Rs. 16.19	Rs. 15.53

In view of above submission, company requested this Department to issue necessary directive to NPPA to re-notify the retail price of captioned formulations by excluding the additionally incorporated factor of 0.95905

M/s Sun Pharmaceutical Industries Limited : Retail price for Rosuvas CV 10 was notified as Rs. 10.96/- per tablet via NPPA SO 2398 (E) dated 12.06.2018.

Working sheet for this notification was made available on NPPA website only on 25.06.2018. Company could get to know about this calculation anomaly though this working sheet only. It is evident from working sheet that the market data of July 2017 were used in retail price computation. Additionally a factor of 0.95905 was incorporated in arriving final retail price as Rs. 10.96/- per tablet for Rosuvas CV 10. It is pertinent to note that GST rate was made effective from 01.07.2017 and in captioned retail price computation market data of July 2017 was considered wherein already post GST PTR were appearing. However, in instant case GST rate was factored additionally @ 0.95905% in the calculation which appears to be erroneous,details of which are mentioned below:

Product	Retail Price based on July 2017 data (Per Tablet)	Final retail price by factoring 0.95905 (Per Tablet)
Rosuvas CV 10	Rs. 11.43	Rs. 10.96

In view of above submission, company requested this Department to issue necessary directive to NPPA to re-notify the retail price of captioned formulations by excluding the additionally incorporated factor of 0.95905.

NPPA noted the issue raised by the companies and agreed that same may be reviewed based on the direction given by DoP.

DOP noted that GST rate was made effective from 01.07.2017. NPPA considered the market data of July 2017 for retail price computation, wherein GST rate was already factored in the data. However, NPPA erroneously again factored GST rate in the calculation.

As a result, DOP passed the following order

“NPPA is hereby directed to revise the retail prices of the formulations Triolmezest CH 20 tablets (containing Olmesartan IP 20mg+Amlodipine Besylate IP eq. to Amlodipine 5mg+Chlorthalidone IP 12.5mg) and Triolmezest CH 40 tablets (containing Olmesartan IP 40mg+Amlodipine Besylate IP eq. to Amlodipine 5mg+Chlorthalidone IP 12.5mg) [of Sun Pharma Laboratories Limited] and Rosuvas CV 10 (containing Rosuvastatin calcium eq. to Rosuvastatin 10mg+Clopidogrel Bisulphate eq. to Clopidogrel 75mg) [of Sun Pharmaceutical Industries Limited], without factoring additional GST @ 0.95905%., within fifteen days of issue of this order.”

Issued on this date, the 4th day of September, 2018