Biopharmaceuticals are taking over chemical drugs in the medical race to save lives. They’re a burgeoning business in India, a multi-billion-dollar market growing at an annual rate of 19 percent.
The products include insulin, vaccines, blood products such as albumin, hormones, and monoclonal antibodies used as anti-cancer agents – medicines that treat life-threatening diseases. But unlike chemical-based drugs, they are often highly temperature sensitive and vulnerable to degradation, depending on how and where they are made, transported or stored.
Biopharmaceuticals require special attention to ensure their quality throughout their life cycle from production to expiry and disposal. A recent study of 17,451 batches of samples assessed over a decade (2011–21) found 2.34 percent were of poor quality. Even though this is less than for chemical drugs, what is worrying is the category they belong to, which includes medicines used to treat life-threatening conditions such as cancer, heart attack, haemophilia and serious injuries or burns, and even extended to in vitro diagnostic kits used to detect HIV and hepatitis antibodies.
