Government of India has stayed suspension of Natco Pharma's Albupax manufacturing (product) licence. Albupax is a nanotechnology based drug and is the first generic version of the international brand Abraxane of Abraxis Bioscience Inc, USA. Albupax consists of Paclitaxel in an albumin-bound nanoparticle form and is used to treat breast cancer.
Drugs Controller General of India (DCGI) had suspended Natco Pharma's manufacturing license allegedly for not passing the test measuring endotoxin levels.
Later, Natco Pharma appealed under the Drugs and Cosmetics Rules against the suspension order. Natco's plea said an appropriate test method needs to be employed to evaluate nanotechnology based protein-bound formulations as the testing method used for such formulations are highly complex and variable.
Content Guide
