The Department of Pharmaceuticals (DoP) has ruled that there is no there is no provision in DPCO 2013 to differentiate consumer pack and dispensing pack while calculating the ceiling price. The DoP's ruling in this regard came while examining a review application filed by IPCA Laboratories against price fixation of “Metoclopramide syrup 5mg/5ml (Perinorm syrup 30 ml)”.

Earlier, the National Pharmaceutical Pricing Authority (NPPA) had fixed the ceiling price of metoclopramide syrup 5mg/5ml (Perinorm syrup 30 ml) through its notification S.O. No. 3431(E), dated 10.11.2016. Aggrieved by the NPP notification, IPCA Laboratories filed a review petition under paragraph 31 of DPCO 2013.

In the review petition, the petitioner contended it is seen from the calculations that out of five packs being taken into consideration, four packs are of 30ml and one pack is of 450ml. 30ml pack is for consumer whereas 450ml pack is not for consumer and is a dispensing pack. The quantity in this pack is 15 times the quantity in a consumer pack. The bigger pack is dispensing pack for use in hospitals or by dispensing chemists. PTR of this pack cannot be clubbed with PTR of consumer packs to work out average PTR for determining ceiling price. Therefore 450ml pack needs to be omitted from calculations and if necessary separate prices need to be fixed for two types of packs intended for different purposes.

They further submitted that average PTR of four consumer packs (30 ml) varies between Rs. 0.38 per ml to Rs. 0.44 per ml whereas average PTR of 450ml pack comes to Rs. 0.16/ml. Therefore average cannot be worked out of heterogeneous packs showing vide variation in PTR per unit as indicated above.

In reply, the NPPA commented that DPCO, 2013 does not differentiate between consumer and dispensing pack while calculating the ceiling price for Scheduled formulations. Ceiling price has been fixed based on the data provided by IMS for the month of May, 2012 under NLEM 2011 and the data provided by pharmatrac for the month of August, 2015 under NLEM 2015 as per existing practice. The request of company to revise the ceiling price based on S.O. 1993(E) dated 03.6.2016 is not tenable as the same is applicable for IV Fluid where therapeutic safety and efficacy is involved pertaining to the special type of packing material used.

During examination, the DoP noted that the main contention of the petitioner company is that to calculate average price to retailer, NPPA has clubbed PTR of consumer pack with dispensing pack while calculating the ceiling price for formulation metoclopramide 5mg/5ml. In this connection, it is observed that in DPCO 2013, there is no provision to differentiate consumer pack and dispensing pack while calculating the ceiling price. The formulation under consideration is only a syrup and not IV fluid/injectable and has got no added therapeutic advantage being in consumer pack. The request of the company to revise the ceiling price based on S.O. 1993(E) dated 03.6.2016 is also not tenable as the same is applicable for IV fluid where therapeutic safety and efficacy is involved pertaining to the special type of packing material used.

“The request of the company that PTR of consumer pack with dispensing pack should not be clubbed while calculating the ceiling price of metoclopramide syrup 5mg/5ml cannot be acceded to, as there is no provision in DPCO, 2013, and the review petition stands rejected,” the DoP ordered.