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The Blood Bankers' Legal Handbook the Blood Bankers' Legal Handbook the Blood Bankers' Legal Handbook the Blood Bankers' The Blood Bankers’ Legal Handbook The Blood Bankers’ Legal Handbook The Blood Bankers’ Legal Handbook The Blood Bankers’ Legal Handbook ’ Legal Handbook By M.L Sarin Senior Advocate Honorary Legal Adviser to The Indian Society of Blood Transfusion and Immunohaematology And The Blood Bank Society, Chandigarh Assisted by Harpreet Singh Giani Advocate March 2003 Dedicated to Mrs. Kanta Saroop Krishen A pioneer in the field of Voluntary Blood Donation in India Who gave me her daughter, Niti, to love and to cherish And who has motivated millions including my whole family to share the joy of living by donating blood The Blood Bankers’ Legal Handbook The Blood Bankers’ Legal Handbook The Blood Bankers’ Legal Handbook The Blood Bankers’ Legal Handbook Sarin Memorial Legal Aid Foundation Address: # 48, Sector 4, Chandigarh, India Phone: +91 (172) 740339, 742417. Fax: +91 (172) 741135 Email: [email protected] Preface My first attempt to compile a booklet on the legal aspects of blood donation was made in 1996 soon after the Supreme Court judgment was delivered. Since then, my involvement has increased many fold especially as Honorary Legal Adviser to the Blood Bank Society, Chandigarh as well as the ISBTI. The number of my donations has also reached 79. Due to my professional preoccupations, I have not been able to devote as much time as I would have liked to the present work. But the motivation was very strong to release this book before the inauguration of the Rotary and Blood Bank Society Resource Centre at Chandigarh scheduled for mid 2003. My thanks are due to Mr. Harpreet Singh Giani, Advocate, who has assisted me in compiling the entire manuscript and revising the final proofs for the present handbook. M.L Sarin Senior Advocate Chandigarh February 1, 2003 The Blood Bankers’ Legal Handbook The Blood Bankers’ Legal Handbook The Blood Bankers’ Legal Handbook The Blood Bankers’ Legal Handbook Mr. Chief Justice (Retd) S.S. Sandhawalia President Mr. Anupam Kher Noted Film Actor Mr. Jagesh K. Khaitan Treasurer Jt. Managing Director Amrit Banaspati Company Limited Mr. Yashovardhan Saboo Managing Director Kamla Dials and Devices Limited Mr. Sushil Goenka President & Editor in Chief Matrix Media Pvt. Ltd. Mr. M.L. Sarin Secretary General Senior Advocate Punjab & Haryana High Court The Blood Bankers’ Legal Handbook The Blood Bankers’ Legal Handbook The Blood Bankers’ Legal Handbook The Blood Bankers’ Legal Handbook The Blood Bankers’ Legal Handbook The Blood Bankers’ Legal Handbook Page 1. A brief background 1 2. The Common Cause Case and its aftermath 4 3. Setting‐up a blood bank 10 4. Blood Bank Society Chandigarh 13 5. The Rotary & Blood Bank Society Resource Centre at Chandigarh 15 Appendices 1. Glossary 17 2. NACO guidelines for blood storage centres 18 3. National guidelines for appropriate use of Blood 23 4. National Blood Policy 44 5. Common Cause Vs Union of India 54 6. The ISBT Ethical Code For Blood Donation and Transfusion 71 7. Relevant extracts from the Drugs & Cosmetics Rules, 1945 75 8. Bio‐medical waste (Management and Handling) Rules 1998 126 9. Mr ‘X’ Vs Hospital ‘Z’ Legal rights and duties of HIV+ infected blood donors 145 10. Legal Standards for Blood Bags — A case study 159 11. List of addresses 163 12. International Standard ISO 3826 for Blood Bags 165 A Brief Background Chapter 1 A Brief Background Today when medical practitioners talk of conserving blood, of collecting each individual unit of blood and even of splitting up every single drop of blood into its most basic usable components, it is almost unbelievable that just a few centuries ago, bad blood was blamed for virtually each and every ailment that afflicted a patient and that bleeding patients was an acceptable form of treating disease. Though this practice, called Phlebotomy, is no longer prevalent, still it only highlights the importance that the ancient Egyptian, Grecian and European cultures attached to blood. It took the genius of the English physician William Harvey for the first modern scientific study of the human anatomy to be undertaken and for the discovery of the circulation of blood. And that one crucial discovery way back in 1628, was followed up by a series of equally brilliant medical scientists who contributed to the science of haematology. The early success of Richard Lower in 1665 in transfusing blood successfully from one dog to another fuelled a new interest in this promising new field, and at the same time other attempts to transfuse blood from lambs to humans ended in fatal disasters leading to the first blood transfusion related laws in 1677 banning animal to human blood transfusions. By 1818 however, the science of blood transfusion had started gaining ground and doctors like James Blundell had gone on not only to pioneer new instruments, but also to successfully demonstrate the life saving effects of blood transfusions. After these landmark events, hematology has never looked back and today millions of lives are saved in hospitals and emergency rooms each year thanks to the untiring efforts of scientists, doctors, technicians and voluntary workers all over the world. The Indian Context India has never lagged behind in medical advances. Sushruta, acclaimed as the father of surgery in India lived many hundreds of years ago and had already undertaken a scientific study of the human anatomy. Historians have found credible evidence of the doctors of that age practicing advanced surgery, including plastic reconstructive surgery. Even today, Indian researchers and scientists are on the cutting edge of technology and research. However, given the sheer size of our population, it is understandable, though unfortunate, that the benefits of these modern techniques and practices have not 1 The Blood Bankers’ Legal Handbook A Brief Background The Blood Bankers’ Legal Handbook A Brief Background The National Aids Control Organization1 (NACO), in the preface to its National Guidelines for the Appropriate Uses of Blood has underlined the many deficiencies in the Blood Transfusion Service (BTS) across the country. The guidelines highlight the seriousness of the situation and enumerate the many ills that exist in the current blood bank infrastructure. The problem areas identified include an acute shortage of trained personnel and medical resources, the lack of adequate screening mechanisms, the high number of professional blood donors who sell their blood for money, the improper and inefficient use of blood etc. The guidelines2 issued by NACO are however a welcome step towards improving the BTS. But as always, active participation from each and every segment of society is needed to translate good intentions into positive action. Non Governmental Organizations in India have always played a major role in this arena. A number of organizations have in the past stepped in to fill the gaps in the BTS and to provide assistance and guidance. Indeed, the impetus for the framing of a National Blood Policy came from the initiative taken by an NGO, Common Cause, which knocked at the Supreme Court's door and brought the sorry state of affairs to the attention of the apex court. The Supreme Court had in the now famous Common Cause3 case directed the Indian government to come up with a comprehensive action plan to fortify the BTS in the country. The National Blood Policy4 is therefore the direct consequence of that case and also of the efforts of numerous individuals and organizations. The draft policy had been circulated soon after the Supreme Court judgement inviting suggestions from different quarters. Many suggestions were received but the policy was not being finalised. Through the efforts of Mr. Apurba Ghosh, Secretary General of ISBTI, a powerful delegation of five members of parliament from West Bengal alongwith Dr P.L. Dhand, President Mrs. Kanta Saroop Krishen, Mr M.L. Sarin Honorary Legal Adviser & Dr V.P. Gupta, all of ISBTI met Mr Atal Behari Vajpayee, the Prime Minister of India in August 2001 and requested him to take a decision on the National Blood Policy. It goes to the Prime Minister’s credit that soon thereafter the National Blood Policy was finalised and published. There are so many instances of NGOs taking up the cause and performing 1. The National Aids Control Organization of the Ministry of Health and Family Welfare, Government of India (http://naco.nic. in) 2. The NACO Guidelines for Appropriate Use of Blood (See http://naco.nic.in/vsnaco/nacp/blood.htm) : See appendix. 3. See AIR 1996 Supreme Court 929 (See appendix) 4. The National Blood Policy (See http://naco.nic.in/vsnaco/nacp/bidprog.htm) ; See Appendix. sterling work in this field. In some cases, NGOs like the Chandigarh Blood Bank Society have gone so far as to virtually adopt the entire city and the surrounding region and ensuring that the blood services available to the people are amongst the finest in the world. The will already existed, the direction was provided by the Supreme Court of India and as a consequence, the National Blood Policy has been framed. The rest is all up to us. 23 The Blood Bankers’ Legal Handbook The Blood Bankers’ Legal Handbook 2 The Common Cause Case and its Aftermath Filing of the Writ Petition The Voluntary Blood Donation Movement in India was growing very slowly. Most of the blood was collected from professional blood sellers who would indulge in unethical practices in order to make a few rupees. In fact there was a thriving trade in human blood. Blood purchased from undesirable sources, who may be diseased or drug addicts, would be sold for profit and in some cases even diluted to make one unit into two or more. Such sub‐standard blood, when transfused proved more harmful than helpful for the recipients.
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