New Delhi: The Department of Pharmaceuticals (DoP) has accepted the Zydus Healthcare’s review petition against price fixation of “Rosuvastatin 20mg + Clopidogrel 75mg Capsules” and has directed the NPPA to revise the ceiling prices of rosuvastatin 20mg plus clopidogrel 75mg capsules.
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.
Zydus Healthcare Limited had filed a review petition under paragraph 31 of the Drugs (Prices Control) Order, 2013 against notification S.O. No.02(E), dated 01/01/2018 issued by the National Pharmaceutical Pricing Authority (NPPA) fixing the ceiling prices of Rosuvastatin 20mg + Clopidogrel 75mg Capsules.
In its review petition, Zydus has contended that the price fixed by the NPPA for the new drug formulation rosuvastatin 20mg + clopidogrel 75mg capsule is lower than rosuvastatin 10mg or rosuvastatin 5mg, similar formulations of lower strength, and furnished price charts to substantiate its argument.
During the examination, NPPA accepted that it had fixed the retail price of Rosuvastatin 20 mg +Clopidogrel 75 mg capsule manufactured by Synokem Pharmaceuticals Limited and marketed by M/s Zydus Healthcare Limited as Rs. 7.80 per capsule vide S.O. 02(E) dated 01.01.2018 as per the decision was taken in 51st Authority Meeting.
However, on re-examination, it is observed that this price for Rosuvastatin 20 mg + Clopidogrel 75 mg capsule was fixed, which was applicable for Rosuvastatin 20 mg + Aspirin 75 mg and retail price of Rosuvastatin 20 mg + Clopidogrel 75 mg capsule was not fixed by NPPA earlier.
At the time of examination, the DoP has found merit in the Zydus 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.
Giving the decision, DoP stated, “NPPA is hereby directed to refix the retail price of new drug Rosuvastatin 20 mg + Clopidogrel 75 mg as per provision of para 5(1) read with para 9(4) of DPCO, 2013, within a period of one month from the date of issue of the order.”
Below is the attached judgment for the same