The Department of Pharmaceuticals (DoP) has directed the National Pharmaceutical Pricing Authority (NPPA) to to re-fix/revise the ceiling price of the formulation “Pheniramine injection 22.75 mg/ml”.

Delivering its order on a review application filed by Sanofi India Ltd against price fixation of “Pheniramine injection 22.75 mg/ml” by NPPA, the DoP said, “The grievance raised by the petitioner company that negative WPI should not have been considered while fixing the ceiling price of formulation pheniramine 22.75 mg/ml injection has got no merit and stands rejected as the formulation was already in NLEM 2011 and is not a new medicine. NPPA is, however, directed to reconsider the fixation of ceiling price as per para 11(3) & (4) of DPCO, 2013. NPPA is also directed to re-fix/revise the ceiling price of the formulation pheniramine 22.75mg/ml injection within one month of the date of this order, considering the documentary proof submitted by the petitioner company on merit.”

Earlier Sanofi India had filed a review application in which it had challenged the NPPA Order S.O. 3431(E) dated 10.11.2016 for price fixation of their formulation pheniramine injection 22.75 mg/ml. The main contentions of the petitioner company were that the ceiling price for pheniramine 22.75 mg/ml injection has not been fixed in accordance with the spirit of DPCO 2013 and with the NPPP 2012 and also the re-fixation of ceiling price has caused an unintended reduction which is not in accordance with para 9(5) of DPCO, 2013. The price of multi-dose vial of 10ml has been averaged with the price of single dose ampoule of 2ml which is not in accordance with the provisions of para 11(3) of DPCO, 2013. Company has also requested for separate ceiling price for multi dose vial and single dose ampoule. The company also contended that PTR of Avil 2 ml pack has been wrongly considered as Rs. 1.78/2ml ampoule against the correct PTR of Rs. 2.50/2 ml ampoule.

During examination, the DoP noted that Para 18(i) of DPCO 2013 clearly states that the revision of ceiling prices on the basis of moving annual turnover value shall be carried out “as and when the National List of Essential Medicines is revised by the Ministry of Health and Family Welfare or five years from the date of fixing the ceiling price under this Order whichever is earlier.” In view of this, NPPA has revised the ceiling prices of the formulations strictly as per the provision of DPCO 2013. As regards the other point that negative WPI should not be taken while fixing the ceiling price vide notification dated 15.9.2016, since the drugs are not new drugs in NLEM 2015, the WPI impact has to be taken care of while fixing the ceiling prices. Therefore, the petitioner company?s contention in this regard has got no merit.

It further noted that the company representative during the personal hearing submitted that Avil (pheniramine) 2ml ampoule pack is a single dose, while 10 ml vial pack is a multi-dose. In hospital setting, inhouse pharmacies, nurses can easily identify store and separate multi dose vials in emergency, when many doses may need to be given to save many lives. Avil is a life saving medicine in case of anaphylactic shock, a life threatening condition, if not managed with utmost emergency. In view of the specified therapeutic rationale of the formulation, it is proposed that the NPPA may be directed to consider the fixation of ceiling price as per para 11(3) & (4) of DPCO, 2013. As regards PTR of Avil 2 ml pack being wrongly considered as Rs. 1.78/2ml ampoule against the correct PTR of Rs. 2.50/2 ml ampoule, the company submitted scanned copy of the Avil Injections carton of August, 2015 showing the correct MRP of Rs. 30.40 for pack of 10 ampoules of 2ml each. Thus, the correct MRP for 2ml pack is Rs. 3.04 and correct PTR is Rs. 2.50. In view of the above, NPPA may be directed to refix/revise the ceiling price of the formulation pheniramine 22.75mg/ml Injection, considering the documentary proof submitted by the petitioner company on merit.