Hon. Shri. Ghulam Nabi Azad,
Subject: Saving thousands of lives by legalizing Unbanked Directed Blood Transfusion
As you may be aware, in India, thousands of mothers and hundreds of accident victims die every year due to unavailability of timely blood transfusion. India has one of the highest maternal mortality rates in the world and thirty percent of these maternal deaths, mainly in rural areas, are due to haemorrhage in which timely blood transfusion was not available. India has highest number of road traffic accidents in the world, leading to more than 100,000 deaths yearly and many of these are due to lack of timely blood transfusion as most of these accidents occur on roads away from cities.
Along with measures like prevention and timely treatment of anaemia in women, especially in pregnancy, making available timely blood transfusion is a crucial measure to save the lives of these women. However, there are only 2545 licensed Blood Banks in India, most of which are in cities. The Blood Storage Centers advocated by Govt. are very few and majority of them are currently dysfunctional. Therefore, as per W.H.O. guidelines there is 31% deficit of available blood at National level; in rural areas this proportion is much higher. Till this deficit is overcome, (and there are no signs that this will happen in the coming decade or so,) it is necessary to revive the old, established method of ‘Unbanked Directed Blood Transfusion’, UDBT in areas where no blood bank can be accessed within an hour. This method consists of transfusing the blood of a suitable donor selected through matching , and cross matching after testing for pathogens and transfusing his/her blood directly to the patient without storing it in a blood bank. UDBT is as safe as banked blood transfusion if all the ‘mandatory’ tests (including test for HIV), are done. UDBT is allowed by American Food and Drug Administration. In India, it is banned due to fear of spread of HIV infection.
But what needs to be noted is the fact that the problem is not with UDBT but with the unscrupulous elements who indulge in money-making through blood trade and of poor regulatory structure. Even in licensed blood banks currently unscrupulous elements can falsely record that HIV testing has been done, without actually doing it.
Given this background, the Jan Swasthya Abhiyaan would like to point out that to save thousands of avoidable deaths there is a dire need to legalise UDBT along with proper mandatory, well laid out procedure for regulating UDBT including the mandatory tests and record-keeping. We feel that the procedure suggested in the attached note by the Consultative Group (“Proposed GOI Notification to the rules in Schedule K of the Drugs and Cosmetics Act 1940 and Rules 1945”) which has been already submitted, is quite adequate and apt. If it is followed, the chances of spread of HIV or Hepatitis B infection would be no greater than if the blood is given only through blood bank.
It is true that instead of transfusing whole blood, the preferred modality is to transfuse packed red cells or serum or platelets as per need. But we would like to point out that in many licensed blood banks, only whole blood is available and secondly in a life threatening situation, in absence of availability of packed red cells, it is quite justified to use whole blood. In 2001, Govt. of India amended the rule in Schedule K (sub-section 30) of Drugs & Cosmetics Act and allowed Arms Forces Medical Services to do what is akin to UDBT in emergent situations.
We feel that the life of rural woman is no less precious than a jawan and request you to move an amendment to the concerned rule of Drugs and Cosmetics Act under Section K and LEGALISE UDBT.
(Dr.Anant Phadke) (Dr.Amit Sengupta)
for Jan Swasthya Abhiyan
Copy to: 1) Mr. Keshav Desiraju, Secretary, Ministry of Health and Family Welfare
2) Ms.Anuradha Gupta, Additional Secretary Ministry of Health and Family Welfare & MD (NRHM)
3) Dr.Arun K Panda, Joint Secretary, Ministry of Health and Family Welfare (AKP)(R)
4) Dr. T.Sunderaraman, Director, National Health Systems Resource Centre
5) Dr. Tongaonkar R. R.