Blood and blood products: Ethical and legal aspects in India

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Vikas Lodha, B. P. Nagori and Vipin Mathur

Posters: Pharmaceut Reg Affairs

Abstract :

Human blood is covered under the definition of ?Drug? under Sec. 3(b) of Drugs & Cosmetics Act. Therefore, blood banks and blood transfusion service are regulated under the Drugs & Cosmetics Act and rules thereunder. In order to improve the standards of Blood and its components, the Government of India has formulated a comprehensive legislation to ensure better quality control system on collection, storage, testing and distribution of blood and its components. Part X B of Drugs & Cosmetics Rules prescribes the requirements for the collection, storage, processing and distribution of whole human blood, human blood components by blood banks and manufacture of blood products. PART XII B to the Schedule F of Drugs & Cosmetics Rules defines the requirements for the functioning and operation of a blood bank and/or for preparation of blood components, whereas PART XII C prescribes the requirements for manufacture of blood products. In 2002, Government of India published the National Blood Policy. The objective of the policy is to provide safe, adequate quantity of blood, blood components and products. The main aim of the policy is to procure non remunerated regular blood donors by the blood banks. The policy also addresses various issues with regard to technical personnel, research and development and to eliminate profiteering by the blood banks by selling blood. This presentation discusses various ethical and legal aspects involved in the supply of blood and blood products in India.

Biography :

Mr. Vikas Lodha is presently pursuing M. Pharmacy in Pharmaceutical Management & Regulatory Affairs branch at Lachoo Memorial College of Science & Technology, Pharmacy Wing, Jodhpur, India.