The Department of Pharmaceuticals (DoP) has rejected the review application filed by Parenteral Drugs (India) Ltd against the fixation/revision of ceiling prices of glucose injection 10 per cent and mannitol 20 per cent 100 ml by the National Pharmaceutical Pricing Authority (NPPA).

The NPPA through its notification No. S.O. 3131 (E) dated 10.12.2014 had fixed ceiling price of glucose injection 10 per cent and SO No. 3134(E) dated 10.12.2014 fixed ceiling price of scheduled medicine mannitol 20 per cent 100 ml under para 31 of DPCO 2013.

Aggrieved by the notification, Parenteral Drugs submitted a review application dated 12.12.2014 under para.31 of DPCO, 2013 for the review of NPPA Price notifications.

In the review application, the petitioner mentioned that as per clause (d) under the notification SO 3134 (E) pertaining to mannitol injection the MRP for the new manufacturer is Rs.57.75 which is a big increase for the new manufacturer. However, the company whose MRP earlier was Rs.38.85 cannot increase it under para 13(2) of DPCO 2013 as mentioned in note (d) under the notification.

Similarly for dextrose 10 per cent though they cannot increase the price from their MRP Rs.26.25 and the new manufacturer can launch the product at Rs.27.91 MRP per bottle. The petitioner mentioned that this is a very competitive market for IV fluids and the higher MRP is always preferred by the retailers in the hospitals/nursing homes. They are, thus, finding it very difficult to sell their products at lower MRP. PTR for glucose injection 10 per cent was Rs.13.00 and Rs.22.00 for 500 and 1000 ml respectively during May 2012. For mannitol 20 per cent, during May 2012, PTR was Rs.24.00 for 100 ml. Invoices are also submitted for the same.

In reply, the NPPA stated that the PTR of May 2012 for the purpose of price fixation of dextrose 10 per cent of Parenteral Drugs were Rs.9.25 and Rs.16.75 for 500 ml and 1000 ml respectively. The same figure has been considered in working out the price relevant for 10th December 2014 notification. The only change that has been made is in respect of providing WPI for implementing DoP orders.

Thus in current notification only WPI has been changed and which can only be the subject matter of review under para 31 of DPCO 2013. The PTRs of mannitol 20 per cent that were considered in the working were Rs.20 and Rs.50 for 100 ml and 300ml respectively. As per para 13 of DPCO, 2013, all the existing manufacturers of scheduled formulations, selling formulations at price higher than ceiling price (plus local taxes as applicable) notified by government are required to revise their prices downward and existing manufactures selling below the ceiling price notified by the Government shall maintain their existing price. Thus, a manufacturer is not permitted to carry out upward revision in price. The petitioner shall follow the provisions of DPCO, 2013.

After hearing both the petitioner and the NPPA, the reviewing authority DoP ordered, “The points raised by the company have no merit and the review petition is, therefore, rejected”.