Nearly 11 million people donate blood every year voluntary in India. Donating blood is considered to be the greatest service one can do in one's lifetime by saving someone's else life. The donated blood is often kept at blood banks for later use. But ever wondered what law is governing your blood donations or under what law you can be charged if you hide any of your blood history which is used for blood transfusion for someone else, who is the component authority that handle blood related matters? Or why was there need to establish National Blood Transfusion Council?

Surprisingly most of us are not aware of the answer, so to answer the above questions one needs to go back to the history of what and where term Blood was defined and how blood banks emerged.

Blood is considered as a Drug under the 'Drugs and Cosmetics Act, 1940' due to which the blood banks need to get a Licence to store the Blood from Drugs Controller General of India.[i] The term Blood is defined under 'Drugs and Cosmetics rules, 1945' 122EA(c) of Part XB as 'blood means and includes whole human blood, drawn from a donor and mixed with an anti-coagulant'.

The term Blood Bank is defined under 122EA(d) as 'a place or organization or unit or institution or other arrangements made by such organization, unit or institution for carrying out all or any of the operations for collection, apheresis, storage, processing and distribution of blood drawn from donors and/or for preparation, storage and distribution of blood components.[ii]

The first Blood bank was established in Kolkata, West Bengal during the World War II in the year 1942 to help and fulfil the needs of the people who were injured in the battle field. After the war the enthusiasm to help others and donate blood increased.

Voluntarily drives, Camps were held for blood donations. But there was always a chance of the blood samples not being tested properly, blood getting contaminated or the risk of transferring disease through blood transfusion to the patients. In order to safeguard the interest of the donors and to protect the patients a need to establish a National Blood Transfusion council was felt.

History of National Blood Transfusion Council
In the year 1986 the First HIV case was diagnosed in Chennai. The government initiated setting up HIV screening centres to screen the citizens and the blood banks. National AIDS control Programme was set up in 1987 by the Indian Government to control the virus from spreading and to co-ordinate national responses such as blood screening and health education. It was during this time that Blood Transfusion Services gained importance as HIV is transmitted through blood. The modernization of Blood Banks Scheme was launched by the Ministry of Health and Family Welfare and later on merged with NACP-1 in 1992.

The National and State AIDS Control Organisation were set up by the Govt. to develop policies and to oversee the prevention and control programmes related to HIV and AIDS and improve blood safety.

It was during this time that a Civil writ petition was filed in the Supreme Court of India namely Common Cause Vs. Union of India 1992 (discussed later) which submitted deficiencies such as poor management of the blood banks and questioning its operation without licence etc. A committee was constituted to facilitate the matters in question and to submit its report.

One of the recommendations for immediate effect was the setting up of a National Blood Transfusion Council (NTBC) which is a policy formulating apex body pertaining to all matters related to the operation, standard, procedures of blood centres. It was also recommended that with the assistance of National Council the State Council be established. The basic objectives of these Council were to promote voluntary blood donations, ensure there's safe blood transfusion, develop human resources and provide infrastructure to blood centres.

National Blood Transfusion Council
The council is a policy formulating central apex body which aims to provide information on Blood Transfusion Services and Resources and all other matters related to the operation of its blood centres. It also coordinates with the SBTC 'State Blood Transfusion Council' while ensuring that all other Ministries and health programmes are involved with the activities related to Blood transfusion services.

The council performs the administrative functions such as attending matters related to property and financial aspect. Preparation of guidelines for management of blood supply during disasters. NBTC also provides national and international linkages, Quality Management and Quality Assurance services, training and research programmes for Drug inspectors, technicians, medical officers etc.

Some of the important functions of NBTC are as follows:

1. Developing guidelines to define NGO run blood centres to avoid profiteering in blood banks
2. Developing a comprehensive quality management system for the BTS including EQAS/ accreditation, appropriate infrastructure and personnel.
3. Encourage inter and intra country exchange programmes for training and experience of personnel associated with blood banks to improve their quality.
4. Creation of administrative, technical and ministerial and other posts under the society and to make appointments thereto in accordance with the rules and regulations of the societies.
5. Appeals and applications for money and funds in furtherance of the objectives of the NBTC and to accept for the aforesaid purpose gifts, donations, contributions, grants, financial assistances and subscriptions of cash and securities of any property whether movable or immovable from individuals or organisations.
6. Taking appropriate steps to increase the availability of plasma fractions as per the need of the country through expanding the capacity of existing centre and facilitating in establishing new centres.

Common Cause v/s. Union of India 1992 SC
A writ petition by way of PIL was filed in the Hon'ble Supreme Court of India under Article 32 of the Constitution of India. The Judgement was delivered by Hon'ble Justice S.C Agarwal. The Petition highlighted the major deficiency and short-comings related to the matters of the collection, storage and supply of the blood through various blood centres operating throughout the country.

The Prayer of the petition was that an appropriate order or direction should be issued to the Union of India and the States and Union Territories to ensure that proper and concrete steps are taken in a time bound programme initiated for obviating the malpractices, inadequacies and malfunctions of the blood banks all over the country and an action plan be drawn aimed to overcome the deficiencies in the operation of blood banks. This case further discussed the report submitted by M/s. A.F. Ferguson & Co. (A management Consultancy firm which was entrusted by the Ministry of Health, GOI to study the blood banking system in 1990) Its report submitted highlighted the deficiency related to the facilities, licencing Policy for storage of blood.

During the pendency of the writ petition action were taken to revise the rules which were governing the licencing and operation of the blood banks. By way of notification published in the official gazette Part X-B (Rules 122F-112f) in the rules was inserted and Part XII-B was substituted in Drugs and Cosmetics Rules (First Amendment) Rules, 1982.

The report of the committee which was constituted by the Court along with the report of the experts set up by Indian Red Cross Society and the programme that is being implemented by National Aids Control Organisation as well as the submissions of the learned council were taken into consideration by the court while deciding the case. It concluded that with all the above suggestions a suitable action should be taken by the Union and State Government as well as the Union Territories Administration in accordance with the plan for long Term implementation which are suggested by the committee constituted by the Hon'ble Court.

The court held that 'The committee constituted by this court had made concrete suggestions in this regard. We are in the agreement with the recommendation of the said committee that the entire range of schemes related to operation and requirements of blood banks including the launching of effective motivation campaigns for stimulating voluntary blood donations, launching programmes of blood donations and training of its personnel should be entrusted to an autonomous representative body at the National level which may be called National Council on Blood Transfusion as suggested by the committee'.

The court further held that the National Council and State council established should be constituted as societies registered under the Societies Registration Act. The National and State Councils should undertake the measures which are suggested by the committee constituted by the court, the experts committee of Indian Red Cross Society, while coordinating their activities with those of other agencies in this field and the National Aids Control Organisation. While disposing of the petition 18 directions were given by the court for speedy action in this regard.

Some of the directions were related to the establishment of the National Council of Blood Transfusion, its registration, its role, composition, who shall provide the funds, the Role of the Union Government, the Establishment of the State Council in each State and Union Territory, Headquarter of State council, the funds for the council etc were discussed.

Further, the directions relating to programmes and activities of the National and State Council stated that it shall cover the entire range of services relating to the operation and requirements of blood banks. Court also provided for the direction that duly trained Drug Inspector in blood banking operations are posted in adequate numbers to ensure periodic checking of the blood banks throughout the country.

End-Notes:

1. Drugs and Cosmetics Act, 1940
2. Drugs and Cosmetics Rules, 1945

Award Winning Article Is Written By: Ms.Umang Sharma

Authentication No: AU224386235468-31-0822