The Department of Pharmaceuticals (DoP) has directed the National Pharmaceutical Pricing Authority (NPPA) to reconsider the ceiling price fixed by it on rabies immunoglobulin injection 150 IU/ml under DPCO, 2013 and asked it to consider the price to retailer (PTR) of rabies immunoglobulin with 150 IU/ml only while fixing the prices.

Acting on a review application by Bharat Serum and Vaccines Ltd. against fixation/revision of ceiling prices of rabies immunoglobulin injection 150 IU/ml by the NPPA, the DoP said, 'based on the recommendation of the Standing Technical Committee it is recommended that NPPA may be directed to consider the PTR of rabies immunoglobulin 150 IU/ml only, since rabies immunoglobulin 300 IU/ml is not within the purview of DPCO, 2013. The formulation of Abhay RIG with 300 IU/ml may not therefore, be taken into consideration while fixing price of rabies immunoglobulin 150 IU/ml'.

Earlier, the NPPA vide price fixation Order S.O. No. 3350(E) dated 5/11/2013 had fixed/revised ceiling price of Rabies Immunoglobulin Injection 150 IU/ml under DPCO, 2013 included in Section 19.2 (sera and Immunoglobulin) in Schedule-I of the Order. Aggrieved by the notification, Bharat Serum and Vaccines Ltd. submitted a review application dated 15.11.2013 under para.31 of DPCO, 2013 for the review of NPPA price fixation order.

In the review application, the petitioner pleaded that the rabies immunoglobulin 150 IU/ml is the formulation covered under DPCO, 2013 Schedule I (section 19.2.5) while 300 IU/ml is not covered under DPCO 2013.  While fixing the price, NPPA had included price of Abhay RIG which is 300 IU/ml. which is not as envisaged in the DPCO.

It further claimed that Abhay RIG is an equine rabies immunoglobulin and made from equine plasma at recommended dosages of 40 IU per kg body weight whereas their brand Berirab P is human rabies immunoglobulin and is made from human rabies plasma at recommended dosage of 20 IU per kg body weight. These are two different drugs with different dosage and different source. It is incorrect to compare the two drugs, the petitioner pleaded with reviewing authority DoP.

After examining the comments both from the petitioner and the NPPA, the DoP decided: “NPPA may be directed to consider the PTR of rabies immunoglobulin with 150 IU/ml only.”