The department of pharmaceuticals (DoP) has rejected the review application of Panacea Biotec against fixation/revision of retail price of scheduled medicine 'amphotericin B injection (50 mg)' by the national drug regulator 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, Panacea Biotec submitted a review application dated 23.8.2013 under para 31 of DPCO, 2013 for the review of NPPA Price Fixation Order.

In its review petition, the company argued that the NPPA has mixed two different products of amphotericin B i.e. the conventional and the liposomal formulation. The liposomal formulation of amphotericin B was technology licensed by the department of biotechnology (DBT). Range of price mixture taken by NPPA is from Rs. 211 to Rs. 8666 which may not evidently be for the same product and in fact it is not the same product. The company asked the government to seek advice of DBT and DSIR in the matter as IMS Health may not be technically competent to give advice on whether liposomal and the conventional forms to be treated as the same.

The NPPA mentioned that they fixed the ceiling prices on the basis of description given in the NLEM and also as per the data received from IMS Health.

Meanwhile, the reviewing authority, the department of pharmaceuticals, which had received same point for consideration in another review application of Lifecare, Gurgaon, sought comments of DCGI on whether the amphotericin B injection included liposomal amphotericin B and lipid formulation of amphotericin B.  The Department, however, did not receive any reply from the DCGI.

The matter was then put up to the Union minister, wherein it was decided to refer the matter to the Technical Committee.

The Technical Committee recommended that liposomal form may be categorized separately. However, despite findings of the Technical Committee, differential pricing cannot be done on the basis of existing provisions of DPCO. The DPCO 2013 works on a market based price concept where intermediate processes, cost and other technical considerations have not been taken into account and only the market price has been taken as the sole criteria for price fixation.

Scheduled I of the DPCO has included the NLEM 2011 which does not provide for different categorization of liposomal form of amphotericin B Injection.  

After considering all the matters, the DoP felt that even though the Technical Committee had felt that a case is made out for separate categorization 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. “In view of the above the review application of the petitioner stands rejected,” the DoP ordered.