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TMI Blog1996 (1) TMI 468X X X X Extracts X X X X X X X X Extracts X X X X ..... e ensured that the blood that is available with the blood banks for use is healthy and free from infection. 2. In this petition filed by way of Public Interest Litigation under Article 32 of the Constitution the petitioner has high-lighted the serious deficiencies and short-comings in the matter of collection, storage and supply of blood through the various blood centers operating in the country and has prayed that an appropriate writ order or direction be issued directing the Union of India and the States and the Union Territories, who have all been impleaded as respondents in this petition, to ensure that proper positive and concrete steps in a time bound programme are immediately initiated for obviating the malpractices, malfunctioning and inadequacies of the blood banks all over the country and to place before this Court a specific programme of action aimed at overcoming the deficiencies in the operation of blood banks. 3. For the purpose of regulating its collection, storage and supply, blood is treated as a 'drug' under the Drugs and Cosmetics Act, 1940 (hereinafter p referred to as the Act'). In the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as &# ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... centers are not functioning efficiently and upto 85 per cent of blood collected in the country is not screened for AIDS. Under an action plan to screen blood for AIDS 37 blood testing centers were to be set up in 29 cities, but only 11 testing centers were functioning by July, 1990, and training of technicians for these centers was lagging. (iv) The blood banks presently thrive on bleeding 4000 to 5000 regular professional donors in 18-20 cities. The professional blood donors, which include many women, are reported to be victims of ill health, low Hemoglobin levels and many infections, and are bled at frequent intervals by the commercial blood banks: (v) Storage facilities in the blood banks are far from satisfactory. The blood banks have necessarily to possess facilities like refrigerators exclusively for storage of blood with a specified range of temperature, for ensuring safety of blood. In the existing blood banks many items of equipment remain unattended for years, electricity failures are frequent, generators are a rarity. This applies not only to commercial blood banks but even to some of the government hospitals. Many items of the basic equipment needed for blood banks ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... Lalgudi Vaidyanathan Kannan, Deputy Drugs Controller, on behalf of the Union of India it is stated that after the receipt of the report of M/s. Ferguson & Co., the Drugs controller, India, by his letter dated August 23, 1990 asked all the State Drug Controllers (who are the licensing and enforcing authorities under the Act) to ensure that inspections are carried out of all commercial blood banks and unlicensed Government blood banks keeping in view the standards prescribed in the Act and rules and a phased programme of inspection covering first the commercial/private blood banks and thereafter the Government blood banks was suggested. It was also suggested that the private/commercial blood banks should not be allowed to operate unless they fulfill all the requirements prescribed in the Rules and each unit of blood is tested for blood transmissible diseases (Hepatitis, HIV, Syphilis etc.) and that unlicensed blood banks are to be licensed only after ascertaining that they conform to the standards laid down under the Rules. It was also suggested to the State Governments that the licences of blood banks who do not comply with the provisions of the Rules should be cancelled and the St ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... tral Government. - 1. To build up adequate blood banking services at State/District level including provision of trained/qualified man power. Necessary action should be initiated in right earnest for achieving the objective in view. 2. To educate and motivate people about blood donation on a voluntary basis. 3. To provide adequate encouragement to voluntary donors. 4. To enforce quality control of blood in all its facets of collection, distribution and storage. In the said affidavit it was also stated that although the World Health Organisation has prescribed that nearly 40 lakhs units of blood is required for the country, the collection is only 19.5 lakhs units at present and, therefore, it is not possible to ban professional donors at this stage unless the donations of blood by way of voluntary donation are increased. In the said affidavit it was further stated that most of the Government Blood Banks are lacking in man power, training and laboratory facilities to test blood for blood transmissible diseases and to augment this, the Central Government has provided funds to various State Government during 1990-91 and 1991-92 to modernise the Government Blood Banks. Accordi ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ions by the Committee constituted by the Court, the Indian Red Cross Society constituted a committee of experts to examine the matter and to prepare a draft blue print. The said committee of experts in this report dated April 15, 1995 has indicated the following fields in which measures are required to be taken: 1. Building a powerful voluntary blood donation movement to augment supplies of safe quality blood and blood components. 2. Exercising economy by processing whole blood for blood components. 3. Introducing screening procedure to minimize the danger of transmissible diseases like AIDS, Hepatitis etc. 4. Standardize technological procedures for rigid enforcement of quality control, and good manufacturing practices. 5. Providing technical services-for raising the standard of Blood center operations and assistance for administrative, motivational and technical problems encountered. It has proposed an action plan-in three parts: Immediate Plan, short Term Plan and Long Term Plan, which are as follows : Immediate Plan 1. To establish an administrative unit at the national headquarters under the charge of a project director. 2. To identify and strengthen a minimum ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... esentatives of regional centers to provide necessary guidance for uniform and standardised policies and practices. Long Term Plan : 1. To upgrade all other blood centers. 2. Establishment and up gradation of blood centers in areas where it does not exist. 3. Planning of more regional centers. 4. Establishing fractionation centers. 5. Establishment of therapeutic centers for blood related disorders. 6. Programmes for indigenisation of equipped software and reagents. 7. Establishment of tissue typing facilities for Bone Marrow and organ transplant. After considering the said report of the Committee of experts set up by the Indian Red Cross Society, the Committee constituted by the Court submitted its final report which was filed along with the affidavit of Shri Ashwani Kumar, Deputy Drugs Controller of India in the Directorate General of Health Services dated October 26, 1995. The Committee has made the following recommendations and has suggested steps for revamping the system of blood banks in the country in the form of plans for implementation on immediate basis and for long term implementation. FOR IMMEDIATE IMPLEMENTATION : (i) A National Council on Blood Tr ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ies formulated by the National Council, effectively implementing the policies and programmes formulated by them. (iii) Programmes and activities of the National Council and State Councils should 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 utilisation transport, quality control and archiving system, cross-matching of blood between donors and recipients, separation and storage of component of blood, and all the basis essentials of the operations of blood banking. LONG TERM OBJECTIVES : (i) The programme formulation at the national level and State levels should take into account the requirements of laying down targets for achievement, including the establishment of appropriately designed and equipped blood banks, ensuring that all blood ban ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... hould be rendered impossible through suitable action under appropriate legislation. It shall be a policy objective of the Ministry of Health as well as the National Council and the State Councils established on the basis of these recommendations that the prevalent system of professional donors is discouraged through utilisation of all appropriate media, through withdrawal of licenses where any such blood bank has been licensed, and by launching prosecutions under the appropriate provisions of law. The objective of total elimination of professional donors should be achieved in at period of not more than two years through utilisation of all requisite measures. For attainment of objectives & programmes of the local organisations, the State Govt. will be approached for providing the requisite Inspectorate for continuing inspection of blood banks. 11. The Committee has taken note of the programme for preventing infection and strengthening of Blood Banking system in the country that is being implemented by the National Aids Control Organisation, which is annexed as Annexure-I to the report of the Committee. 12. The Indian Association of Blood Banks has been impleaded as a party in thes ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... nds from various sources including of contributions from trade, industry and individuals the National Council and the State Councils should be constituted as societies registered under the Societies Registration Act. The National Council and the State Councils should undertake the measures suggested by the Committee constituted by the Court as well as the Committee of experts appointed by the Indian Red Cross Society and while doing so they should coordinate their activities with those of the National Aids Control Organisation and other agencies in this field. Keeping in view the potentialities of the harm in the prevailing state of affairs and the need for speedy action in this regard, we consider it appropriate to give the following directions ; 1. 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 th ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 utilisation, 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 essentials of the operations of blood banking. 8. The National Council shall undertake training programmes for training of technical personnel in various fields connected with the operation of blood banks. 9. 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. 10. The National Council shall take steps for starting special postgraduate courses in blood collection, processing, storage and transfusion and allied fields in various medical college ..... X X X X Extracts X X X X X X X X Extracts X X X X
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