The Department of Pharmaceuticals (DoP) has rejected the review petitions filed by several companies including Albert David, Baxter (India), Indi Pharma, Gland Pharma, etc. against the ceiling of prices fixed by the NPPA on their products.

Albert David had filed the review application under para 31 of DPCO, 2013 against the NPPA notification S.O. NO. 1819(E) dated 21st June, 2013 fixing ceiling price of scheduled medicine Glucose Injection 10 per cent.

The department held personal hearing on December 20, 2013 on the case, before disposing of the petition. “Para 4 of DPCO, 2013 clearly states the principle of market pricing and clarifies that the basis is that the price is to be retailer plus margin/markup. In the present case also the principle is the same. As clarified by NPPA the price of 10 per cent formulation is on the basis of average market price and has been fixed accordingly in the DPCO, 2013. The price of five per cent Dextrose was fixed under DPCO, 1995, therefore, there is a difference. Since the principle involved is that the basis of pricing is the market price, and not the strength, packaging, etc., therefore, there is no case to interfere with the order of NPPA fixing the ceiling price of 10 per cent formulation,” the DoP in its order said.

Likewise, Baxter (India) had challenged the prices fixed by the NPPA on ringer lactate injection. “The review application of the company is rejected on the ground that DPCO, 2013 does not provide for a separate pricing for separate packing material.

“However, the Department has set up a committee to advise whether the variants available in the market have different therapeutic efficacy. This case is being referred to the committee to advise whether there is additional therapeutic efficacy of two port packs to enable this Department to take a decision on whether a separate pricing should be provided to two port bags,” the DoP ordered.

Indi Pharma had challenged the prices fixed by the NPPA on its product clindamycin tablets (300 mg). After hearing the DoP ordered, “As Schedule I covers only clindamycin tablets and NPPA has also considered only the prices of tablets, the ceiling price will be applicable to tablets only. NPPA is, however, directed to revalidate the data by appropriate survey of evaluation through all known sources by giving wide publicity through their website and other public media. Till then prices notified by NPPA to be maintained by all.”

Likewise, Gland Pharma had filed a review application against the NPPA's pricing on heparin sodium injection (5000IU/ml); Adcock Ingram Healthcare against NPPA's pricing on metoclopramide injection 5mg/ml; Synchem Laboratories had filed a review application against the NPPA's pricing on oral rehydration salts powder for solution; and Neon Laboratories had also filed the review application against fixing ceiling price of scheduled medicine lignocaine hydrochloride + adrenaline injection (2% + adrenaline 1:200000) under para 31 of DPCO, 2013. But, all these review petitions were rejected by the national drug regulator NPPA.