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NPPA told to review price fixation again

In a major setback to National Pharmaceutical Pricing Authority (NPPA), the Department of Pharmaceuticals (DoP) has directed the apex drug pricing regulator to review its notification 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 Drugs Prices Control Order, 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 August 20 dated notification had fixed the ceiling price of the mentioned drugs under DPCO, 2013.

While defending the step taken by NPPA, the regulator said that as per available information Arco Lifesciences was the only manufacturer of this formulation as IMS Health didn’t provide any information about the availability of two other brands of the instant formulation. The NPPA, however, said that prices have been fixed as a ‘monopoly’ situation under the mentioned clause of DPCO 2013.

With new facts coming to notice, the NPPA asked all the four players -- JB Chemicals, Unijules Life Sciences, Bayer Zydus Pharma and Arco Lifesciences -- to provide the data to the regulator within a fixed time and after that the order would be reviewed by revalidating the data.

Notably, the NPPA had placed a request on its official website requesting all the manufacturers of this formulation and different pharma bodies to provide the data in respect of the said formulation. However, no response was received from other manufacturers except Arco Lifesciences.
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