Drugs advisory board says no to direct blood transfusion

Many experts and activists have been demanding that the government allow direct donor-to-patient blood transfusion because of blood shortages across India, especially outside cities. But the Drugs Technical Advisory Board (DTAB) of the Centre has decided to continue with the existing system of blood distribution which bans unbanked direct blood transfusion (UDBT).

The Drugs Controller General of India (DCGI), G N Singh, confirmed that DTAB has decided to continue with the existing regulation for blood distribution because it felt that controlling infections which can spread through blood is more important at present. DTAB was asked to look into the matter following concerns expressed by various groups in the recent past.

Decision unjustified: activists

Activist Anant Phadke, who is co-convener of advocacy group Jan Arogya Abhiyan in Pune, says the decision is bad news. Direct blood transfusion may not be the ideal solution as technology has advanced and transfusing complete blood is not healthy, but when people are dying for lack of blood, no logic is justified, he says.

Officials believe blood banks are the best system for distributing blood, but in the absence of a regulatory system, these banks fudge data, claim activists.

So, the government should strengthen its regulatory system and should permit people to allow UDBT, they add.

Now, the only solution is that rural people organise themselves like HIV positive people, then only their voices will be heard, says Phadke.

Amit Sen Gupta from Jan Swasthya Abhiyan (JSA) termed the development “disappointing”.

On September 25, JSA, the Christian Coalition for Health in India and the Association of Rural Surgeons of India (ARSI) wrote a letter to the government of India, demanding regularisation of UDBT.

In the letter, JSA claimed that thousands of mothers and hundreds of accident victims die every year because of non-availability of timely blood transfusion. India has one of the highest maternal mortality rates in the world and thirty per cent of these maternal deaths, mainly in rural areas, are due to haemorrhage, requiring blood transfusion. India also has the highest number of road traffic accidents in the world, leading to more than 100,000 deaths yearly and many of these happen because of lack of timely blood transfusion in places away from cities, the letter claimed.

Too few blood banks

In India, there are only 2,545 licensed blood banks, most of which are in cities. The blood storage centres advocated by government are very few and majority of them are currently dysfunctional. Therefore, as per World Health Organisation (WHO) guidelines, there is 31 per cent 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 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 because of fear of spread of HIV infection say activists.

UDBT was perfectly legal before the 1999 amendment of the Drugs and cosmetics Act 1940 & Rules 1945 because UDBT was not under the preview of this law.
 





 
 

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