Blood Transfusion Service is a vital part of the National Health Service and there is no substitute for Human Blood and its components. Increasing advancement in the field of Transfusion Technology has necessitated to enforce stricter control over the quality of Blood and its products. In most of the developed countries, the blood banking system has advanced in all facets of donor management, storage of blood, grouping and cross matching, testing of transmissible diseases, rationale use of blood and distribution. The Govt. has the full responsibility for the blood programme even though, in some countries, the management of blood transfusion services are delegated fully or partly to an appropriate non-governmental organization (NGOs) working on a non-profit basis, e.g. Red Cross Society. When a NGO is assigned this responsibility, the Govt. should formally recognize it and give a clear mandate formulating the national blood policy, it is important to consider policy decisions enforcing appropriate regulations or necessary functions of health service to ensure high quality service and safe blood.
In order to improve the standards of Blood
and its components, the Central Govt. through Drugs Controller General of India,
has formulated a comprehensive legislation to ensure better quality control system
on collection, storage, testing and distribution of blood and its components. Central Govt. amended from time to time the existing
requirements of Blood Banks in the Drugs & Cosmetics Act, 1940 and Rules thereunder
to meet the latest standards. Consequent to a public
litigation case recently, Supreme Court of India directed Central Govt. to enact
a comprehensive legislation on Blood Banks in collection, storage, testing and distribution
of blood and its components. In this context, the office
of Drugs Controller General of India made draft rules
to further amend the existing law in the Drugs & Cosmetics Act, 1940 and Rules
thereunder to meet the direction of Hon’ble Supreme Court in order to improve the
blood banking system in the country.
Government of India published in the year 2002 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 , development and to eliminate profiteering by the blood banks by selling blood. The policy also envisages that fresh licences to stand alone blood banks in private sector shall not be granted and renewal of such blood banks shall be subjected to thorough scrutiny.