All About Blood Donation in India By: Mrityunjoy Seal

September 14,2018:

The Author,  Mrityunjoy Seal is an Advocate at Calcutta High Court and Founder, Sealex Legis Firmus, Advocates & Consultants. Hon Patron to Communiqué Medico Legal Community.

Popular function of Blood Donation or Voluntary Blood Donation is prevalent in the context of growing socio-political bandwagon. Particularly the political parties, local clubs, social groups, sports bodies find a pretext to organise Voluntary Blood Donation Camps either to celebrate or as an annual ritual to mobilise support of local population.

In a rarest of rare situations, a Good Samaritan could be witnessed coming forward to donate blood on own volition to save the life of a patient needing blood infusion.

It is nonetheless a controversial matter that the word ‘voluntary’ is superfluously added before the word ‘donation’. In such situations, the donors, receivers and organisers tend to ignore some essential legal aspects of Blood Donation or Collection by adhering to the rules prescribed under Part XIIB of the Drug and Cosmetics Rules, 1945.

At the very outset, Blood donation as its literal meaning could convey must not be a donation for consideration. It is well known that not even 50% of the total blood transfusion in the country is sourced by private (voluntary) blood donation. It denotes that the balance need is fulfilled by commercial donors, with a miniscule percentage coming from known, near and dear ones of the recipient patients. In such an unregulated area, it is important to know the legal framework to regulate blood donation and related issues in India.

Schedule - F (Rule 78 Part X) – Part XIIB of the Drug and Cosmetics Rules, 1945 provides for various aspects of blood donation and related issues. A summary is made as below.

Following are the summary points for processing of blood components from blood by a blood bank:

Part XIIC provides for requirements for manufacture of blood products.

Starting from collection to maintenance and dispensation, equipment, testing, records keeping and trained personnel are the key areas for setting and up-keeping a blood bank.

Following are the extracts of the Rules in connection with blood donation/collection:

No person shall donate blood and no blood bank shall draw blood from a person, more than once in three months. The donor shall be in good health, mentally alert and physically fit and shall not be inmates of jail, persons having multiple sex partners and drug-addicts.

• The donors shall fulfill the following requirements, namely: -

(a) the donor shall be in the age group of 18 to 65 years; (b) the donor shall not be less than 45 kilograms; ( c) temperature and pulse of the donor shall be normal; (d ) the systolic and diastolic blood pressure are within normal limits without medication; (e) hemoglobin which shall not be less than 12.5 grams; (f) the donor shall be free from acute respiratory diseases; (g) the donor shall be free from any skin diseases at the site of phlebotomy; (h) the donor shall be free from any disease transmissible by blood transfusion, insofar as can be determined by history and examination indicated above; (i) the arms and forearms of the donor shall be free from skin punctures or scars indicative of professional blood donors or addiction of self injected narcotics.

(2) Additional qualifications of donor – No person shall donate blood, and no blood bank shall draw blood from a donor, in the conditions mentioned in column (1) of the Table given below before the expiry of the period of deferment mentioned in the column (2) of the said Table. 

Table: Deferment of blood donation CONDITIONS PERIOD OF DEFERMENT

(l)   Immunoglobulin 12 months

• No person shall donate blood and no blood bank shall draw blood from a person, suffering from any of the diseases mentioned below, namely:–

A Blood Donation Camp may be organised by –

• a licensed designated Regional Blood Transfusion Centre ; or (b) a licensed Government blood bank; or (c) the Indian Red Cross society;

NOTES: (i) ― Designated Regional Blood Transfusion Centre shall be a center approved and designated by a Blood Transfusion Council constituted by a State Government to collect, process and distribute blood and its components to cater to the needs of the region and that center has also been licensed and approved by the Licensing Authority and Central Licence Approving Authority for the purpose. (ii) The designated Regional Blood Transfusion Centre, Government blood bank and Indian Red Cross Society shall intimate within a period of seven days, the venue where the blood camp was held and details of group wise blood units collected in the said camp to the Licensing Authority and Central Licence Approving Authority.

For holding a Blood Donation Camp, the following requirements shall be fulfilled/ complied with, namely:

(A) Premises, personnel etc.

(B) Personnel for out-door Blood Donation Camp

(C) Equipments

Each of these heading comprises of a wide list of required paraphernalia as detailed in the Rules. It is vital to check each of these items is in place before proceeding on blood donation/ collection.

In Writ Petition (civil) 91 of 1992, the Supreme Court of India laid down short term and long term policies and procedures for Blood Donation so that commercial blood donation is completely eradicated from the country. The guidelines are considered to be the supreme parameters to set the law right for setting up Blood Donation Camps and Blood Banks, as well as conducting Voluntary Blood Donations. [Common Cause vs. Union of India And Others, judgment passed on 4 January, 1996]

The first paragraph of the judgment is reproduced for understanding its spirit.

“1. Blood is an essential component of the body which provides sustenance to life. There can be no greater service to the humanity than to offer one's blood to save the life of other fellow human-beings. At the same time blood, instead of saving life, cannot lead to death of the person to whom the blood is given if the blood is contaminated. As a result of developments in medical science it is possible to pre-serve and store blood after it has been collected so that it can be available in the case of need. There are blood banks which undertake the task of collecting, testing and storage the whole blood and its components and make the same available when needed, In view of the dangers inherent in supply 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.”

The apex court in its said judgment noted the following sordid picture in this regard:

(i) Out of the total number of 1018 blood banks as many as 616 are reported to be unlicensed. There are only 201 licensed commercial blood banks; the supply of blood by licensed commercial blood banks is only about 1/4th of the blood used in the hospitals of the country.

(ii) No medical checkup is done on the blood sellers; their health status is not examined. The blood trade flourishes with poor people like unemployed, rickshaw pullers, drug addicts selling their blood. Such blood sellers suffer from various infections and their haemoglobin is lower than the prescribed level. It has been reported that there are many persons who donate blood 5-6 times in a month; poverty makes them to do so first but later it is reported to become like an addiction, the blood seller enjoying the dizziness due to reduced supply.

(iii) It is a mandatory requirement to conduct tests on blood which is to be administered to a patient or to be issued to hospitals for transfusion. The blood so issued has to be free from AIDS, viral hepatitis, malaria, veneral diseases etc. It is reported that mandatory tests which are required to be done are rarely conducted. Most of the AIDS surveillance centres 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 centres were to be set up in 29 cities, but only 11 testing centres were functioning by July, 1990, and training of technicians for these centres 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 haemoglobin levels and many infections, and are bled at frequent intervals by the commercial blood banks:

Blood Donation Camps should not therefore be organised devoid of the given paraphernalia or guidelines laid down by the apex court in that behalf as a matter of ritual or celebration. Similarly the Blood Collection Agencies should be aware of the legal provisions in this regard. It is equally advisable to acquaint with the views and guidelines of the apex court by a study of this judgment by the stake holders.

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