NPPA panel fixes retail price of Torrent Pharma Atorvastatin, Clopidogrel Bisulphate, Aspirin FDC

New Delhi: The National Pharmaceutical Pricing Authority (NPPA) panel has fixed the retail price of hard gelatin capsule containing Atorvastatin Calcium plus Clopidogrel Bisulphate plus Aspirin manufactured by Windlas Biotech and marketed by Torrent Pharmaceuticals.

The retail price of each hard gelatin capsule containing Atorvastatin Calcium plus Clopidogrel Bisulphate plus Aspirin has been set at Rs. 12.92 per capsule excluding GST.

Atorvastatin Calcium plus Clopidogrel Bisulphate plus Aspirin is a combination drug of blood-thinning agents and cholesterol-lowering agents, primarily taken for the prevention of heart attack and stroke.

Atorvastatin is an HMG-CoA reductase inhibitor used to lower lipid levels and reduce the risk of cardiovascular disease including myocardial infarction and stroke.

Clopidogrel Bisulfate is a thienopyridine with antiplatelet activity. Clopidogrel bisulfate irreversibly alters the platelet receptor for adenosine diphosphate (ADP), thereby blocking the binding of ADP to its receptor, inhibiting ADP-mediated activation of the glycoprotein complex GPIIb/IIIa, and inhibiting fibrinogen binding to platelets and platelet adhesion and aggregation.

Aspirin is a salicylate used to treat pain, fever, inflammation, migraines, and reducing the risk of major adverse cardiovascular events.

At a recent Multidisciplinary Committee of Experts meeting, The Committee noted that as per the provisions of DPCO 2013, the retail price of each hard gelatin capsule contains Atorvastatin Calcium IP eq. to Atorvastatin 40 mg (as coloured pellets) + Clopidogrel Bisulphate IP eq. io Clopidogrel 75 mg (as two brown coloured film coated tablets each containing 37.5 mg Clopidogrel tablet IP) + Aspirin IP 75 mg (as enteric coated white-coloured peIlets) for. Windlas Biotech Ltd. (manufacturer) and Torrent Pharmaceuticals Ltd. (marketer) is required to be calculated based on the market data for the month of March 2021.

The Committee further noted that data of the formulation is not available in Pharmatrac database for the month of March 2021, however, the data of the formulation started appearing from April 2021.

The Committee also noted that the applicant company has claimed retail price of Rs. 18.00 per capsule excluding GST.

The Committee deliberated upon the matter in detail and decided to fix the retail price of the subject formulation by calculating as per the formula provided In DPCO 2013 for calculating retail price of new drugs based on April 2021 data as available in Pharmatrac database.

Accordingly, the Committee recommended the retail price of each hard gelatin capsule contains Atorvastatin Calcium IP eq. to Atorvastatin 40 mg (as coloured pellets) + Clopidogrel Bisulphate IP eg. to Clopidogrel 75 mg (as two brown colored film coated tablets each containing 37.5 mg Clopidogrel tablet IP) + Aspirin IP 75 mg (as enteric coated white-colored pellets) for Windlas Biotech Ltd. (manufacturer) and Torrent Pharmaceuticals (marketer) at Rs. 12.92 per capsule excluding GST.