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.
Article 21 under part III titled fundamental rights of the Constitution of India clearly spells out that no person shall be deprived of his life. Blood transfusion can be life saving and also can be fatal, therefore, comes under this section of fundamental rights. Besides under chapter XIV of the Indian Penal Code Section 269 provisions for fine and imprisonment for negligent act likely to spread infectious disease dangerous to life and section 270 of the Malignant Act likely to spread infection of disease dangerous to life covers blood transfusion and blood banking in all aspects.
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:
The portions of the Act are compensatory in nature.
- 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.
Public Interest LitigationOn a public interest litigation filed by a Delhi based organisation 'Common Cause' by a writ petition (civil) no 91 of 1992 under Article 32 of the Constitution of India, Hon'ble Justice S C Agarwal and Hon'ble Justice G B Pattanaik on January 4, 1996 issued the following directives:
- The Union Government shall take steps to establish forthwith a National Council of Blood Transfusion as a society registered under the Societies Registration Act. It would be a representative body having in it representation from the Directorate General of Health Services of the Government of India, the Drug Controller of India, Ministry of Finance in the Government of India, Indian Red Cross Society, private blood banks including the Indian Association of the Blood Banks, major medical and health institutions of the country and non-Government organisation active in the field of securing voluntary blood donations. In order to ensure coordination with the activities of the National Aids Control Organisation, the Additional Secretary in the Ministry of Health, who is in charge of the operations of the programme of National Aids Control Organisation for strengthening the blood banking system could be the President of the National Council.
- The National Council shall have a secretariat at Delhi under the charge of a Director.
- The basic requirements of the funds for the functioning of the National Council shall be provided by the Government of India but the National Council shall be empowered to raise funds from various other sources including contributions from trade, industry and individuals.
- In consultation with the National Council, the State Governments/ Union Territory Administration shall establish a State Council in each State/ Union Territory which shall be registered as society under the Societies Registration Act, The State Council should be a representative body having in it representation from Directorate of Health Services in the State, State Drug Controller, Department of Finance of the State Government/Union Territory Administration, important medical institutions in the State/Union Territory, Indian Red Cross Society, private blood banks, Non-Government Organisation active in the field of securing voluntary blood donations. The Secretary to the Government in charge of Department of Health could be the President of the State Council.
- The State Council should have its headquarters at the premises of the premier medical institution or hospital in the State/Union Territory and should function under the charge of a Director.
- The funds for the State Council shall be provided by the Union of India as well as the State Government/Union Territory Administration. The State Council shall also be empowered to collect funds in shape of contributions from trade, industry and individuals.
- The programmes and activities of the National Council and the State Council shall cover the entire range of services related to operation and requirements of blood banks including the launching of effective motivation campaigns through utilisation of all media for stimulating voluntary blood donations, launching programmes of blood donation in educational institutions, among the labour, industry and trade, establishments and organisations of various services including civic bodies training of personnel in relation to all operations of blood collection, storage and utilising, separation of blood groups, proper labelling, proper storage and transport, quality control and archiving system, cross-matching of blood between donors and recipients, separation and storage of components of blood, and all the basic essential of the operations of blood banking.
- The National Council shall undertake training programmes for training of technical personnel in various fields connected with the operation of blood banks.
- The National Council shall establish an institution for conducting research in collection, processing, storage, distribution and transfusion of whole human blood and human blood components, manufacture of blood products and other allied fields.
- The National Council shall take steps for starting special postgraduate courses in blood collection, processing, storage and transfusion and allied fields in various colleges and institutions in the country.
- In order to facilitate the collection of funds for the National Council and the State Councils, the Government of India (Ministry of Health and Ministry of Finance] should find out ways and means to secure grant of 100% exemption from income tax to the donor in respect of donation made to the National Council and State Councils.
- The Union Government and the Government of the States and Union Territories should ensure that within a period not more than one year all blood banks operating in the country are duly licensed and if a blood bank is found ill equipped for being licensed, and remains unlicensed after the expiry of the period of one year, its operations should be rendered impossible through suitable legal action.
- The Union Government and the Governments of the States and Union Territories shall take steps to discourage the prevalent system of professional donors so that the system of professional donors is completely eliminated within a period of not more than two years.
- The existing machinery for the enforcement of the provisions of the Act and the Rules should be strengthened and suitable action be taken in that regard on the basis of the scheme submitted by the Drugs Controller (I) to the Union Government for upgradation of the Drugs Control Organisation in the Centre and the States (Annexure II to the affidavit of Shri R Narayanaswami. Assistant Drug Controller, dated September 16,.1994. )
- Necessary steps be taken to ensure that Drug inspectors duly trained in blood banking operations are posted in adequate numbers so as to ensure periodical checking of the operations of the blood banks throughout the country.
- The Union Government should consider the advisability of enacting a separate legislation for regulating the collection, processing, storage, distribution and transportation of blood and the operation of blood banks in the country.
- The Director General of Health Services in the Government of
- India, Ministry of Health shall submit a report by July 15, 1996 about the action taken in pursuance of these directions.
- It will be open to the Director General of Health Services, Government of India as well as the National Council to seek clarification/modification of these directions or further directions in this matter.
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.