The Department of Pharmaceuticals (DoP) has rejected the Lifecare Innovations' review petition against fixation/revision of retail price of scheduled medicine 'amphotericin B injection (50 mg)' by the National Pharmaceutical Pricing Authority (NPPA).
Earlier, the NPPA vide price fixation Order S.O. No. 1912(E) dated 28/6/2013 had fixed/revised retail price of scheduled formulation amphotericin B injection (50 mg) under DPCO, 2013.
Aggrieved by the notification, Lifecare Innovations Pvt. Ltd. submitted review application dated 10.7.2013 under para 31 of DPCO, 2013 for the review of NPPA Price fixation Order S.O.No. 1912(E) dated 28/6/2013 fixing ceiling price of scheduled formulation amphotericin B injection (50 mg) under DPCO, 2013.
In its review petition, the petitioner Lifecare Innovations contended that the data used by NPPA includes liposomal amphotericin B and lipid formulation of amphotericin B, liposomal and lipid formulations are wrongly included in the price fixation exercise. If the right formulation is used, the ceiling price of Rs. 4245.32 will come down to approximately Rs. 400 only. While the liposomal and lipid formulations will be out of the price control net, liposomal and lipid formulations are different products and cost wise they vary substantially i.e. Rs. 400 and Rs. 8000. Clubbing dissimilar products is not in the interest of industry and research and ultimately the patient. The company further mentioned that no government document says that amphotericin B injection is lyposomal amphotericin B injection.
In reply, the NPPA mentioned that amphotericin B injection 50 mg per vial is a scheduled drug and the price has been notified by NPPA after considering the information provided by IMS Health as per provision of DPCO. This formulation is delivered in dry powder injection. Lyophilized product is allowed also with the lipid used as a drug carrier in the medicine.
The matter was then put up to the then minister (I/c), C&F wherein it was decided to refer the matter to the technical committee. The technical committee after considering presentation given by the company in its meeting held on 7.1.2015 recommended that liposomal form of amphotericin B injection is different from the conventional amphotericin B injection in respect of R&D, technology, manufacturing process, etc. and, therefore, deserved to be separately categorised.
After hearing all the parties, the reviewing authority DoP opined that even though the technical committee had felt that a case is made out for separate categorisation for liposomal form, it is not permissible within present framework of the DPCO. Thus the review application cannot be accepted and ought to be rejected.
However, since on the basis of recommendations of the technical committee it appears to be a genuine case which deserves differential prices, clarification/amendment/footnote in Schedule I on the basis of a consolidated proposal from NPPA with all supporting documentation could be considered separately. This process would, however, be separate from the review application which is proposed to be rejected for the reasons mentioned above.
“In view of the above, the review application of the petitioner stands rejected,” the DoP ordered.