Blood and blood components are categorised as a "drug" under Section 3(b) of Drugs and Cosmetics Act, 1940 because of their interna adminstarion. This Act and the Rules thereof provide the legal framework for regulating the functions of blood banks, which in turn directly irnpart and determine the quality of the blood transfusion service delivery in the- country. Since initial formalities, the ambit of the Drugs and Cosmetics Act1940, has been expanded and the Rules have frequently been amended to incorporate blood as drugs because of their internal administration and use in treating diseases. The transfusion of blood cells is also transplantation and cells must survive and function after transfusion in order to have therapeutic effect. As with drugs, adverse effects may occur due to blood transfusion. All these necessitates careful consideration and handling of service in accordance with the law of the land.
Consumer Protection Act
Consumer Protection Act of 1986 came into force in July, 1987 for all goods and services, covers all sectors - private, public, cooperative etc It enshrines the six rights of the consumers:
Right to safety
Right to be informed
Right to choose
Right to be heard
Right to seek redressal
Right to consumer education
Supreme Court Directive
The Supreme Court on November 13, 1995 upheld the National Consumer Commission's judgement of April 1992, whereby patients who received deficient services from medical professions and hospitals are entitled to claim damages under this Act. Naturally, blood banking service comes under this Act and both donor and recipient may take the cover of this Act.
Drugs and Cosmetics Act
In accordance with the directive of the Supreme Court, NACO appointed an expert committee to revise the Drugs and Cosmetics Rules Pertaining to blood banking. After a series of meetings spanning over two years the amended Drugs and Cosmetics Rules virtually a total revision came into force with effect from April 5. 1999. The rules thereafter were modified thrice till 2003.
Under this act and its rules, no blood bank in the country can function without first obtaining license from the Central License Approving Authority of the Ministry of Health and Family Welfare on the basis of recommendation of Director, Drug Control of the state by abiding the condition laid down in the Act and the Rules. The license has to be renewed on expiry.
The most important point of this legal provision that the donor motivators should take note of is that blood from voluntary blood donor in out door camps can only be collected by:
A licensed Government Blood Bank
Indian Red Cross Society
A licensed Regional Transfusion Centre designated by State Blood Transfusion Council constituted by the State Government.