The Department of Pharmaceuticals (DoP) has directed the National Pharmaceutical Pricing Authority (NPPA) to revalidate the data under para 9(1) of DPCO 2013 by appropriate survey or evaluation and revise the prices of ilaprazole + domperidone capsules (Checkcid-D SR) as desired by the Aristo Pharmaceuticals Ltd which had filed a review application with the DoP on this issue.

Earlier, the NPPA vide price fixation Order S.O. No. 3151(E) dated 10.12.2014 had fixed/revised retail price of ilaprazole + domperidone capsules (Checkcid-D SR) under Drugs (Prices Control) Order, 2013 (DPCO, 2013).

Aggrieved by the NPPA notification, Aristo Pharmaceutcals submitted a review application dated 23.12.2014 under para.31 of DPCO, 2013 for the review of the NPPA price fixation order.

In its review petition, Aristo Pharmaceutcals mentioned that NPPA notified the price of this combination under para 6 based on the monopoly criteria treating Ajanta Pharma as the only manufacturer/marketer of the product. In the review application, details of 5 brands manufactured/marketed by different companies have been given by the petitioner. The price, therefore, should have fixed under para 5 based on the criteria in para 4 (1) of DPCO taking into consideration the average PTR of all the manufacturers/marketers. The rates given by the petitioner for different brands available in the market are between Rs. 99 to Rs. 109.

In reply, the NPPA stated that the price was fixed by applying monopoly condition as per para 6(1). As per Pharma Trac, only one company was manufacturing the formulation and thus monopoly condition has been applied.

After hearing both the parties, the DoP commented that the petitioner mentioned that there are 5 brands manufactured/marketed by different companies and, therefore application of para 6 based on monopoly criteria treating Ajnata Pharma as the only manufacturer of the product is not correct. NPPA representative mentioned that the price was fixed applying monopoly condition under para 6(1) as the data providing company i.e. Pharma Trac in this case, has mentioned that only one company was manufacturing the said formulation.

But there are sufficient provision under para 9 (1) of DPCO 2013 under which NPPA may revalidate the data by appropriate survey or evaluation, the DoP commented and ordered, “NPPA may revalidate the data under para 9(1) of DPCO 2013 by appropriate survey or evaluation and revise the price.”