A legal response to the issue of Safe Blood

1.      This representation seeks to bring to the notice an issue of grave national importance and is an urgent demand for justice. This relates to the state of blood transfusion services in the country, and the need to conduct a review of the existing legislation and rules pertaining to the collection, storage, urgent supply and transfusion of blood and blood-products because of the difficulties encountered by both patients and medical service providers, particularly in rural areas.

 2.      Blood is an essential component of the body, which provides sustenance to life. ‘Blood to the needy patients’ is a subject of human life and death. Blood for transfusion can either be made available through services of Blood banks or can be taken from a donor and after doing all the tests, directly given to the patient without “banking” or storing. This is termed as Unbanked Directed Blood Transfusion                  (“UDBT”).

 3.      The services of blood banks was started and improved by the Government to improve the supply of blood available to the patients, and steps were taken to improve the state of blood banks in India. However, blood banks remain a service available only to those who can afford it. Surgeons in rural areas, where approximately three quarters of India’s population stays, have long used UDBT in life-saving major surgeries, treatment of complicated childbirths and other critical medical cases.  This method of blood transfusion was perfectly legal till 1999, but after that, an amendment was made in Part XB of The Drugs and Cosmetics Rules, 1945 (“Rules”) and collection of blood came under the purview of blood banks, apart from storage, processing and distribution of whole human blood. Hence, even collection of blood could only be done by a licensed blood bank. UDBT was rendered illegal and blood transfusion equipment was not to be provided to the doctors engaging in direct blood transfusion.

             URGENT NEED OF UDBT IN RURAL AREAS

 4.      The aim is to bring to light the actual implementation and utilisation of the blood banks in rural areas and the urgent need of UDBT in the same. There is a huge gap between framing the laws for establishing blood banks and utilisation of the same in rural areas. The operation of a standard blood bank requires an air-conditioned environment with round-the-clock power supply, specially designed refrigerator, other expensive sophisticated equipment and management by a medical officer and full-time technical staff. Even though this may be a possibility in urban areas, small towns and rural areas are facing problems because of various reasons namely:

 a)     Non availability of blood in emergency situations

b)     Non availability of blood banks in rural areas

c)      Time taken to obtain and deliver blood from blood banks

d)     Cost to the Donor in blood from blood banks at between Rs.500 and 1,000 rupees per unit from a blood bank.

e)     Problems regarding transportation: both 24hr availability, distance and costs incurred in carrying blood from distant blood banks

f)       Need for insulated containers to avoid wastage of  blood carried from blood banks

g)     Variable quality / purity of blood bank products

 6.         The scarcity of blood banks in rural areas and unavailability of safe stored blood in reasonable time at affordable cost in villages result in the loss of many lives due to the delay caused. The worst affected are the women, as seen from the statistics of UN Population Fund (UNFPA), World Health Organisation, UN Children's Fund and the World Bank which puts India on top of the list of high maternal mortality rates at 19%.[1] Transportation of blood from a blood bank is another major hurdle with problems related to quick contamination of the blood due to lack of proper equipment and the contamination that is caused due to the same. Surgeons, obstetricians & other qualified clinicians now available in nodal villages are greatly handicapped due to unavailability of blood. Surgeries and treatment of critically ill patients are delayed and patients incur huge expenses 'AND SOME TIMES, LOSE THEIR LIVES ON THE WAY’[2] if they are referred to nearby bigger towns or cities and not treated in the villages immediately.

 7.         Keeping the above in mind, the direct method of blood transfusion, i.e. UDBT is a viable solution to the problems caused by unavailability of safe, stored blood in small towns and rural areas for the following reasons.

a)     Immediate availability of blood in life saving situations, anywhere, anytime, even in remote places, specially keeping in mind the high rate of maternal mortality caused due to heavy bleeding in rural areas.

b)     No risk of spoiling of blood during transportation, storage or due to expiry

c)      Least travelling expenses and cost of getting blood from a nearby city

d)     Presence of pool of voluntary donors in the villages, usually relatives of         critically ill patients

e)     Freedom to surgeons in nodal villages to perform surgeries at an early stage              which is safer, cheaper & convenient for patients.

 8.            The procedure of UDBT is for a particular patient and blood has to be transfused to that particular patient only, meaning 'it is directed to a particular patient. According to the Drug and Cosmetics Act, 1940 (“Act”) whole blood is a drug. Blood is collected and mixed with 'anticoagulant solution in bottle'. Thus this act of a doctor amounts to 'compounding and dispensing' of a drug to his own patient and may not come within the definition of 'manufacturing' (nor sale, distribution or storing) under Section 3 (f) of the Act.

9.            The current legal framework governing the collection and storage of blood under              the Drugs and Cosmetics Act, 1940 (“Act”) and Rules is unconstitutional and   violative of the principles enshrined in the Constitution of India:

a)     The present laws are not conducive for maintaining a proper and efficient healthcare system in India.

b)     The loss of lives caused by such unavailability of blood goes against the ‘Right to life’ under Article 21 enshrined in the Constitution of India, 1950 which is the basic and the most indivisible human right available to every person.

c)      Patients in rural areas suffer and the rate of deaths is high because of the critical unavailability of blood in emergency situations. The hands of surgeons, doctors and clinicians in such areas are tied because of the provisions of prosecution under the abovementioned Act. This goes against the ‘right to health’ which has been identified by the Supreme Court as part of Article 21 enshrined in the Constitution of India in Pt. Parmanand Katara v. Union of India [(1989) 4 SCC 286] and Paschim Banga Khet Majoor Samiti v. State of West Bengal [(1996) 4 SCC 37]. ‘Right to maternal healthcare’ specially recognized by the Delhi High Court in Laxmi Mandal vs Deen Dayal Harinagar Hospital [172 (2010) DLT 9] as part of ‘Right to life’ under Article 21. 

d)     The current legal framework regarding blood transfusion under the existing Act and Rules is violative of both Article 21 and Article 14, i.e. Right to Equality of the Indian Constitution. Schedule K (Sub section 30) of the Rules[3] provide exemption to the Armed Forces Medical Services from obtaining a Licence to operate a Blood Bank and has allowed to collect, process and transfuse blood in emergent situations, which require life saving emergency surgeries/or transfusions.

 9.            There is a need for reform in the existing legal framework in relation to blood transfusion. UDBT is a viable option for saving many lives who face death in rural areas for want of blood, and should be legalized under conditions as determined by the appropriate authority.

 10.        It would be pertinent to note certain relevant provisions of the American Food and Drugs Regulations. The Code for Federal Regulations lay down provisions for establishment, registration and product listing for manufacturers of human blood and blood products under Part 607. They provide an exemption for blood product establishments under Section 607.65 to "Practitioners who are licensed by law to prescribe or administer drugs and who manufacture blood products solely for use in the course of their professional practice." UDBT is a procedure where doctors and medical practitioners "manufacture blood products" by mixing blood with anti-coagulants in the blood collection bag, and use the blood for their own patient "solely for use in the course of their professional practice". This entire process which comes within Section 3 (f) of the Act as explained in paragraph 8 above is exempted under the American Food and Drugs Regulations.

 11.        The procedure of UDBT would not in any way interfere with the investigations related to AIDS. It can be ensured that the Donor's blood is checked for HIV according to methods accepted by WHO (World Health Organization) and now accepted by NACO. It will be in the same manner as suggested by 30(3) in Schedule K of the Rules which provide exemption to the Armed Forces Medical Services to transfuse blood in emergent situations. Clause 30 lays down conditions for transfusing blood in emergent situations and clause 3 states that “each blood unit shall be tested before use for freedom from HIV I and II antibodies, Hepatitis B surface antigen, malarial parasites and other tests specified under the monograph “Whole human Blood” in current edition of Indian Pharmacopoeia.”

 12.        It may also be pertinent to note that the Government amended the Rules and came with the provision of establishing ‘Blood Storage Centres’ under sub section 5B. However, the idea of amending the Rules to establish ‘Blood Storage Centres’ as an alternative to UDBT in rural areas has not been successful. Very few blood storage centres have been functional, because of problems in getting licenses to establish one. The functional centres do not have the basic infrastructure, like specially designed refrigerators, trained staff and air-conditioners, to store blood. Failure of electricity in rural areas is another major hurdle in the effective functioning of blood storage centres as the blood brought from the blood banks cannot be stored for a long time, thus defeating the entire objective behind setting up such centres. UDBT is the most viable option in solving the problem of blood supply in rural areas.

 13.        Keeping in mind the above, it is respectfully prayed that:

a)     Necessary amendment should be made in the Drug and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 should be brought for a convenient arrangement of blood transfusion for emergency and needy patients in rural areas who have no facility of blood banks.

b)     Small mid-zonal & peripheral hospitals in ‘Civilian’ areas may be brought under the said exemption of the Act applicable to Armed Forces Medical Services.

c)      Enforcement of any other suitable enactment as the Ministry deems fit to allow civilian doctors working in these hospitals to collect & transfuse the whole human blood in emergent situations, which require life saving emergency surgeries or transfusions.

d)     Blood Collection Bags/bottles needed to collect Blood should be made available legally to these doctors doing UDBT in Rural areas.

This will ensure that the legal framework would be in sync with the ideals of ‘right to equality’ and ‘right to life’ as enshrined in the Constitution.

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[1] Trends in Maternal Mortality: 1990 to 2010 available at http://www.unfpa.org/webdav/site/global/shared/documents/publications/2012/Trends_in_maternal_mortality_A4-1.pdf

[2] It would be pertinent to mention two deaths in Robertsganj, Sonabhadra district, Uttar Pradesh. Even with a new Blood Bank now operational in Robertsganj, the lack of timely supply from the Blood Bank contributed to the two patients’ death.

Patient D (Ref: 188953): arrived at Jinan Jyoti Christian Hospital (JJCH) in Robertsganj at 8.00pm on 12.01.12 with Post Partum Hemorrhage, B.P. not recordable on admission with severe anemia after a live delivery at the Govt. Hospital. She is bleeding and in shock – the surgeon needed to do an emergency explorative laparotomy for which blood was essential. It took the relatives 4 hours to obtain 1 Unit of blood with difficulty due to it being night time from the (new) Robertsganj Blood               Bank, which they brought at midnight. The patient died.

Patient E (Ref: 152109): She had C -section on 16.03.11 at JJCH. After surgery the patient developed Disseminated Intravascular Coagulation and went into shock needing an urgent blood transfusion, as due to her unstable condition, she could not be shifted to Benares. One Unit of Blood was obtained and transfused, but the next day a further 3 Units were needed, but not available in time from the Blood Bank. Sadly she expired at 01.35am on 18.03.11

[3] 30. Whole Human Blood collected and transfused by Centers run by Armed Forces Medical Services in border areas, small mid zonal hospitals including peripheral hospitals, Field Ambulances, Mobile Medical units and other field medical units including blood supply units in border, sensitive and field areas:

All the provisions of Chapter IV of the Act and rules made there under which require them to be covered by a licence to operate a Blood Bank for collection, storage and processing of whole human blood for sale or distribution subject to the following conditions:- 

1.   These Centers shall collect, process and transfuse blood in emergent situations, which require life saving emergency surgeries/or transfusion.

2.   These centers shall be under the active direction and personal supervision of a qualified Medical Officer, possessing the qualifications and experiences specified in condition (i) of Rule 122-G.

3.   Each blood unit shall be tested before use for freedom from HIV I and II antibodies, Hepatitis B surface antigen, malarial parasites and other tests specified under the monograph “Whole human Blood” in current edition of Indian Pharmacopoeia.

4.   These centers shall have adequate infrastructure facilities for storage and transportation of blood 

5.   The blood collected and tested by such centers shall be transfused by the Centre itself and may be made available for use of other peripheral Armed Forces hospitals or centers during operational circumstances.