The Department of Pharmaceuticals (DoP) has directed the National Pharmaceutical Pricing Authority (NPPA) to review its notification dated 20.8.2014 on fixation of ceiling prices of sodium meglumine diatrizoate injection 60 per cent and 76 per cent by revalidating the data as mandated under para 9(1) of DPCO, 2013.

The DoP's order in this regard came in response to a review application filed by Bayer Zydus Pharma Limited against fixation of ceiling prices of sodium meglumine diatrizoate injection 60 per cent and 76 per cent. Earlier, the NPPA vide price fixation Order S.O.2092(E) dated 20.8.2014 had fixed the ceiling price of sodium meglumine diatrizoate injection 60 per cent and 76 per cent under Drugs Prices Control Order, 2013 (DPCO, 2013).

Aggrieved by the NPPA notification, Bayer Zydus Pharma submitted review application dated 10.9.2014 under para.31 of DPCO, 2013 for the review of NPPA Price fixation Order No. S.O.2092(E) dated 20.8.2014 fixing ceiling price of sodium meglumine diatrizoate injection 60 per cent and 76 per cent under para.4 of DPCO, 2013 included in Schedule-I of DPCO, 2013.

A personal hearing in the review matter was accorded to the petitioner by the reviewing authority, DoP, on 23.9.2014.

The petitioner argued that there are three major players having more than 1 per cent market share i.e. J B Chemicals, Unijules Life Sciences and Bayer Zydus Pharma.  Therefore, the method of fixation of price of the formulation i.e. “monopoly” should not have been applied by NPPA.

The NPPA representative mentioned that as per available information Arco Lifesciences was the only manufacturer of this formulation and thus the prices have been fixed as a “monopoly” situation under para 6 of DPCO 2013. NPPA had placed a request on the website requesting all the manufacturers of this formulation and different pharma associations to provide the data in respect of the said formulation. However, no response was received from other manufacturers except Arco Lifesciences. In the absence of information prices have been fixed on the information provided by Arco Lifesciences.

After hearing both the petitioner and the NPPA, the DoP commented that in the instant formulation, NPPA did not get any information from IMS Health.  A request was accordingly placed on the website requesting concerned manufacturers/marketing companies to provide PTR and MAT value. A copy of the O.M. was also sent to Pharma Associations. As per NPPA no company had provided the requisite information except Arco Lifesciences, based on which the said formulation was considered to be a ‘monopoly’ formulation and the prices were fixed under para 6 of DPCO 2013.

The DoP then ordered, “The four players J.B. Chemicals, Unijules Life Sciences, Bayer Zydus Pharma and Arco Lifesciences may be requested to provide the data to NPPA within a fixed time and NPPA should review the notification dt. 20.8.2014 by revalidating the data as mandated under para 9(1) of DPCO, 2013.”