For a law on blood banks

Print edition : July 15, 2005

India's blood-banking system has serious shortcomings, and the government is yet to act on a 1996 Supreme Court directive to consider enacting legislation to regulate the functioning of blood banks.

PURNIMA S. TRIPATHI in New Delhi

At the Rotary Blood Bank in New Delhi, Niharika Singh, Miss India 2005 Earth, donates blood. More than any legal or bureaucratic control what can help blood banks is the achieving of cent per cent voluntary donation.-MANISH SWARUP/AP

INDIA can do with more blood donors. Only around 45 per cent of the seven million units of blood that the country needs every year is met through voluntary donation. "Replacement" donation or blood donated by a person, usually a friend or relative of a patient, as "replacement" for the blood given to the patient, accounts for the rest of the demand. This situation has led to various malpractices in blood transfusion services, which go on unchecked in the absence of a single institutional structure to control blood banks.

"Replacement" donation has apparently become another form of professional donation, which was banned in January 1998 following a Supreme Court directive in a 1996 judgment on a public interest petition filed by Common Cause, a voluntary organisation in New Delhi. It took two years to bring the ban into effect as the infrastructure to implement it had to be put in place .

But problems remain. Drug Controllers, who are the regulating authorities for blood banks, are ill-equipped to handle the task despite bodies such as the National AIDS Control Organisation (NACO) pointing out the malpractices from time to time. As a result, there have been many instances when "life-saving" blood transfusions ended up transmitting diseases such as AIDS and Hepatitis B or C. Though there have been no studies on the number of such cases, experts say that the transfusion of infected blood is responsible for around 6 per cent of AIDS and hepatitis cases in the country.

Union Health Minister Anbumani Ramadoss admits the irrationality of Drug Controllers regulating blood banks, but says it is not easy to change things immediately. "Maybe two years down the line I will take blood banks out of the purview of Drug Controllers and place them under NACO. But right now we are not thinking about it. Instead, we are concentrating on improving things within the given framework," he told Frontline.

Mismanagement of blood transfusion services has meant that only around 30 per cent of all the blood that is collected is used, because most of the patients need only blood components such as red blood cells and plasma platelets. The rest of the blood goes waste. This happens because most of the blood banks do not have facilities for component separation and a patient is invariably given the whole blood. Component separation would have enabled the transfusion of the other components to other patients. NACO admits on its web site: "It has been estimated that approximately 30 per cent transfusions are either unnecessary or wasteful."

Successive governments at the Centre have paid only lip-service to the need to set up the infrastructure required for blood transfusion services. However, the United Progressive Alliance (UPA) government promises to be different. "Our focus in this sector is on setting up more component separation units. We have already set up 82 such units and plan to set up another 200-250 in the next three years," said Anbumani. He added that the government was committed to providing support to these units.

According to Dr. N.K. Bhatia, deputy director of the Rotary Blood Bank in New Delhi, Rs.2,500 crores is spent every year to import blood components such as albumin, globulins, factor-VIII and factor-IX. The only facility for fractionating blood plasma into these products is situated at the KEM Hospital in Mumbai. But even this unit has not been in use for several years, and only recently the UPA government started taking steps to make it operational.

Though NACO officials say the government proposes to set up more plasma fractionation units in Delhi, Kolkata and Chennai, the Health Minister ruled it out for the present. "The cost factor is prohibitive. I have tried involving the corporate sector to revive the facility in Mumbai, but their response was discouraging owing mainly to the high cost involved. Importing them [blood components] works out cheaper," he says.

A major problem plaguing blood banks is poor monitoring and control because of the multiplicity of agencies involved. Blood and blood products are under the regulatory control of the Drug Controller (General) of India, which is the Central licensing authority, assisted by State Drug Controllers. Even the Health Minister finds it hard to explain the logic behind this and has suggested placing it under NACO, which is supervising the blood safety programme, in a couple of years. But experts think this will only make matters worse. "NACO is not the competent agency. The latest CAG [Comptroller and Auditor-General] report has indicted NACO for letting its budget lapse. What we need is a truly autonomous agency manned by competent people from the blood transfusion sector, and they should be assisted by branches in the States," says Dr. Bhatia.

The Supreme Court, in its 1996 judgment, had asked the government to consider the advisability of enacting legislation to regulate the collection, processing, storage distribution and operation of blood banks. This is still to happen, though the government has set up, as directed by the court, a National Blood Transfusion Council as the apex policy-making body for blood transfusion services. Subsequently, State Blood Transfusion Councils were also set up. But these bodies have an advisory role only and exercise no control over the blood banks. These are in addition to the Drug Controller, and this multiplicity of authority has resulted in poor monitoring of blood banks.

A NACO study on the condition of blood banks had listed many shortcomings in the blood banking system. Among them were the highly decentralised nature of the blood banking services, the lack of adequate number of trained people, and the shortage of equipment and financial resources needed to provide quality services. Another shortcoming listed was the wide demand-supply gap given the fact that blood is essentially collected through voluntary donation.

Taking advantage of the situation, commercial blood banks mushroomed across the country and added to the problems in blood transfusion services. The standards of the blood-banking system also varied among the States and even within them and some of the banks operated in total isolation, without anyone exercising any control over them.

This was the state of affairs even after the Supreme Court made it mandatory for blood banks to obtain licences and banned professional blood donation.

The government is aware of these problems, says Anbumani Ramadoss but he admits that monitoring of blood banks is difficult. Not all blood banks conduct all the five mandatory tests - for AIDS, malaria, hepatitis B, hepatitis C and syphilis - for the blood that is collected. And even if all the five tests are done, only a few blood banks do the "core antigen" test for hepatitis B; only the "surface antigen" test is done. Around 6 per cent of hepatitis cases in India are attributed to the transfusion of blood and blood products untested for the "core antigen", though there are no studies yet to establish this. Anbumani Ramadoss admits that these are grey areas that have to be taken care of. "Hepatitis B and C remain an area of worry for us," he says. At times hepatitis B and C strains do not show up in the routine tests and this increases the possibility of infected blood being given to a patient.

According to experts such as those at the Rotary Blood Bank, the remedy lies in closing down all private, commercial blood banks and attaining 100 per cent voluntary donation by motivating people to donate blood. "Shut them all down," says Dr. Bhatia. However, that is easier said than done; the huge demand-supply gap prohibits such a course of action.

Quality control is ensured while granting licence, says Anbumani Ramadoss. "No blood bank can operate without a licence now. No licences are given to stand-alone blood banks. Now we give licences only to those affiliated to hospitals and that too only when strongly recommended by the Drug Controllers in the States," he says.

Although the government has taken steps to modernise the existing 815 blood banks, (727 under the government and 88 in the private sector) and set up model blood banks in under-served areas, the only way to ensure total blood safety is to strengthen the regulatory framework (by having a truly autonomous agency of trained professionals) and make quality control more stringent. Besides, blood transfusion medicine should be made a part of the continuing medical education programme in order to have a well-trained manpower in this sector, says Dr. Bhatia.

But more than any legal or bureaucratic control, what can help blood banks is the achieving of cent per cent voluntary donation: a goal highlighted by the government's plan of action in pursuance of the national policy on blood transfusion. "If only the government takes a few innovative measures, such as publicly honouring blood donors frequently or giving them a monetary incentive such as an exemption in income tax, and recognising college/university students who have donated 25 times or more, they could go a long way in motivating people," says Dr. Bhatia. Enrolling more and more persons in the 18-25 age group and encouraging them to become "non-remunerative voluntary repeat donors" could also help, he added.

However, except for the lip-service on Blood Donation Day, October 1, every year or the occasional appeals on Doordarshan's national network, there is no evidence that anything is being done to achieve the goal of cent per cent voluntary blood donation.

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