Role of the National Control Laboratories in Ensuring the Quality, Safety and Efficacy of Blood Products in India

Abstract

National control laboratories (NCLs) are responsible for testing of the batches of drugs prior to their release on the market. NCLs play an important role in strengthening a country’s regulatory systems. The National Institute of Biologicals is an NCL in India for the testing and coenzyme A (CoA) release of biologicals such as biotherapeutics, vaccines, and diagnostic medical devices. Every year, the National Institute of Biologicals tests and CoA releases thousands of batches of blood products following compendial specifications and schedule F, part XII-C (G) of Drugs and Cosmetics Rules 1945. This institute also participates in collaborative studies with the WHO for the establishment of international reference standards. In the last thirteen years (2010–2022), the blood products laboratory at this institute has evaluated 5159 batches of blood products, and 95 batches (1.84%) were declared as not of standard quality. As per CDSCO “the ‘not of standard’ quality products are categorized into three categories: A, B and C”. These 95 batches include all three categories (A, B and C) of “not of standard” quality blood products.