The Department of Pharmaceuticals (DoP) has rejected the review application filed by Sanofi-Synthelabo (India) Pvt. Ltd. against price fixation of “Amiodarone Injection – 50mg/ml” as it was found during examination that the ceiling price fixed by the NPPA is in accordance with the provisions of DPCO, 2013 and is in order.

Earlier, Sanofi-Synthelabo (India) had filed a review petition against price fixation of “Amiodarone Injection - 50mg/ml” by the NPPA through its order No. S.O. 443(E), dated 14.02.2017 issued under DPCO 2013.

In the review petition, the petitioner contended that there was an arithmetical error in computation of price per ml of one brand; incorrect application of price reduction due to monopoly condition; and non-inclusion of Sanofi brand Cordarone's price in working out the average.  

During examination, the DoP noted that the petitioner company has challenged the NPPA Order S.O. 443(E), dated 14.02.2017 for price fixation of their formulation Amiodarone Injection – 50mg/ml on the ground that their product containing Amiodarone (i.e. 50mg /ml) which has a MAT of Rs. 5.8 crores as of August 2015 and PTR of Rs. 56.90 per 3ml i.e. Rs. 18.97 per ml has not been considered while working out the average price. The company also submitted that correct methodology was not followed in arriving at the ceiling price for Amiodarone 50mg/ml Injection. As regards the grievance of the company that their product containing Amiodarone (i.e. 50mg /ml) which has a MAT of Rs. 5.8 crores as of August 2015 and PTR of Rs. 56.90 per 3ml i.e. Rs. 18.97 per ml has not been considered while working out the average price, it is observed that NPPA has considered the Pharmatrac data of August 2015 while fixing the ceiling price of the formulation.

Moreover, as stated by NPPA, the company could not submit the sample of Amiodarone 50mg/ml Injection manufactured in August 2015, in support of their claim. Since the company could not satisfy the requirement of their product being considered, the grievance raised by the company cannot be considered. In regard to the objection of the company regarding correct methodology not being followed in arriving at the ceiling price for Amiodarone 50mg/ml Injection, NPPA has restricted the ceiling price based on S.O. 619(E) dated 26.02.2015 by NPPA as subject formulation was also a scheduled formulation under NLEM 2011 of DPCO, 2013. While fixing the ceiling price, based on Pharma Trac data, NPPA has considered two formulations (Ritebeat 50 mg injection 2 ml and Ritebeat IV 50 mg injection 3 ml) of Torrent Pharmaceuticals Ltd. In view of the above, the ceiling price fixed by NPPA is in accordance with the provisions of DPCO, 2013 and is in order. Moreover, Torrent Pharmaceuticals Ltd., whose products have been considered for fixing the ceiling price, has not raised any objection to the price fixation. In view of the above, the grievances of the company cannot be considered and the review petition may be rejected.

“The grievances raised by M/s Sanofi-Synthelabo (India) Private Limited in their review petition cannot be considered and hence the petition stands rejected,” the DoP order said.