TaxTMI 
TaxTMI 
1996 (1) TMI 468
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....ply of contaminated blood it must be 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 Rul....
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....ts which are required to be done are rarely conducted. Most of the AIDS surveillance 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 ....
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....s are-collecting blood mostly from the relatives of the patients or from the voluntary donors. 7. In the counter affidavit filed by Dr. 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 t....
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....ffectiveness of our services the joint Conference recommends that urgent steps should be taken by the State/Union Territories Governments and the Central 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 trans....
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....be recognised as a nodal agency in the field of blood banking and blood transfusion technology in the country. The Committee suggested that detailed discussions to finalise assessment in this regard may be held with the Indian Red Cross Society. Having regard to the said suggestions 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....
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....ertaken at these centers. 3. Coordination of all other voluntary organisations working for the promotion of the blood programme by the Red Cross society would further help in achieving the target of donor recruitment with greater vigour and better evaluation. 4. A national workshop at the Red Cross headquarters may be organised for officers of all centers being strengthened and the representatives 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 fina....
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....d to the maximum of about 11 members. The Director of Health Services should provide the Committee the basic essentials of secretariat and funds for its functioning. The State Councils, as in the case of National Council, should be registered as Society under the Societies Registration Act for maintaining their identity and for purposes of collection of funds in the shape of contributions from individual and corporate bodies. The State Councils should endeavour to operate on the basis of policies 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 utilisa....
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....rehensive programme for training of personnel operating in relation to various aspects of functioning of blood banks, storage of blood, Fractionalization of blood, and transfusion of blood. (iv) The System of licensing of blood banks will be strengthened to ensure that all quality banks operating in the country are equipped with licenses within a period of not more than one year. Whether any blood banks remain ill-equipped for being licensed, and remain unlicensed after the expiry of the period of one year, their operations should 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 mea....
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....ood donations, launching programmes of blood donations training of personnel in relation to all operations of blood banking should be entrusted to an autonomous representative body at the national level which may be called the National Council on Blood Transfusion, as suggested by the Committee. The National Council would exercise the functions entrusted to it in coordination with similar bodies established at State level which may be called State Councils. In order that they may have their own individuality and funds and are able to raise funds 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....
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.... should function under the charge of a Director. 6. 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. 7. The programmes and activities of the National Council and the State Councils 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 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. ....