The Department of Pharmaceuticals (DoP) has directed the National Pharmaceutical Pricing Authority (NPPA) to revise the ceiling prices of rosuvastatin 20mg plus clopidogrel 75mg capsule of Zydus Healthcare and ranixime plus of Sun Pharmaceutical Industries on review petitions filed by the manufacturers. In its review petition, Zydus has contended that the price fixed by the regulator for the new drug formulation of higher strength is lower than rosuvastation 10mg or rosuvastation 5mg, similar formulations of lower strength, and furnished price charts to substantiate its argument.

In its comments, the NPPA has accepted the error in its ceiling price decision. According to the norms, whenever an application is received by the NPPA for any drug for which it has already notified the price, the same would be extended to the subsequent applicants also. However, the regulator, on re-examination, observed that the price for rosuvastatin 20 mg plus clopidogrel 75 mg capsule was fixed inadvertently on the basis of rates applicable to rosuvastatin 20 mg plus Aspirin 75 mg and the retail price of rosuvastatin 20 mg plus clopidogrel 75 mg was not fixed earlier.

The DoP has found merit in the drug maker’s complaint and asked the national price regulator to refix the rate of the new formulation as per the provisions of the Drug Price Control Order (DPCO) 2013 within a period of one month.

Rosuvastatin 20 mg plus clopidogrel 75 mg tablet is used for prevention of heart attack and stroke. Rosuvastatin is a lipid lowering medication that blocks the body’s ability to produce LDL cholesterol and improves the level of HDL cholesterol. Clopidogrel is an anti-platelet medication. It prevents the platelets from sticking together and decreases the formation of harmful blood clots.

In its review petition against the ceiling price of Ranixime Plus, a combination of cefixime plus ofloxacin, Sun Pharma contended that the regulator had extended previously notified prices without considering market-based data.

As per DPCO 2013, market-based data for fixing the retail price of new drugs available in the market shall be the data available for the month ending immediately before six months of receipt of application for fixing the price of the new drug. “Therefore, the price notified for the formulations is contrary to the DPCO provisions,” the manufacturer argued.

The company also pointed out that the working sheet of price notifications was not uploaded on the NPPA website. A working sheet helps in understanding the price methodology and calculation and brings procedural transparency. While accepting the drug maker’s demand, the DoP noted that the NPPA cannot decide to adopt a different methodology for fixing of retail price of a new drug when the DPCO clearly lays down the procedure for the purpose. It has directed the regulator to re fix the retail price of Ranixime Plus tablet and “take similar action in similar cases” within a period of one month.

Ranixime is a broad-spectrum antibiotic effective in the treatment of a variety of conditions including infections caused by bacteria in urinary tract, throat and lungs.