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India has miles to go for accessing safe blood

Nandita Vijay, BengaluruMonday, November 06, 2017, 08:00 Hrs  [IST]

India has a long way to go for ensuring access to safe blood across its blood banks. The Indian blood transfusion industry is not only fragmented, but equally diverse in ownership patterns... Despite the national average of voluntary blood donation being around 80.5 per cent, there is still an unfulfilled need amongst patients that require regular blood transfusion like thalassemic children, accident victims and cancer patients,  said Dr Shravan Subramanyam, managing director, Roche Diagnostics India in an email interview with Nandita Vijay. Excerpts:


What is the status of blood transfusion in India?
According to a report by World Health Organisation (WHO), the annual blood requirement in India is estimated at 12.8 million units, out of which National AIDS Control Organisation NACO (which is the nodal agency in all matters related to blood safety, collection, storage, testing and distribution and availability) supported blood banks have collected 6.34 million units in 2015-16. About 79 per cent of the NACO-supported blood banks collected blood was through voluntary and non-remunerated blood donation.

According to the data published by the Ministry of Health and Family Welfare, of the 2760 blood banks registered with the NACO, 1564 are privately run and as quoted by a NACO official the government ‘supported’ about 1,300 of them.

Where does India stand globally in blood transfusion?
Globally, ‘safe’ blood transfusion is almost a norm. Canada has reported no transfusion-transmitted HIV cases since 1985. The last known case of HIV transmission in US was in 2008 and the risk of disease spreading through transfusion is one in two million donations. In the UK, 2005 was the year when the last known case of a viral infection, including HIV transmitted through blood transfusion was reported. However, in India there are still instances of patients getting infected during blood transfusion. Media reports suggest that at least 2,000 people were infected with HIV while getting blood transfusions in the last 17 months. India has a long way to go for ensuring safe blood across its blood banks.

However, in the past few years, transfusion regulators and experts across India have embarked upon a drive to ensure that blood transfusion is made safe for patients. Blood banks of state governments like Odisha and those linked to private hospitals and NGOs have come forward to install the globally renowned NAT testing for enabling access to safe blood for their patients. They are already seeing the benefit this technology has brought to patients.

India lacks a centralized national blood transfusion body to enforce polices, appropriate infrastructure, trained personnel. Pls comment. Currently, what are the regulations for the sector?
The blood transfusion industry in India follows a matrix structure of regulation, with multiple governing bodies managing different aspects of the industry. Blood banks are regulated under the Drugs and Cosmetics (D&C) Act. On the one hand, the D&C Act regulates blood as a ‘drug’, which puts it under the ambit of the DCGI. On the other, NACO regulates the collection, storage, testing and distribution of blood and its components, while the National Blood Transfusion Council (NBTC) is the apex body formulating policies relating to the operation of blood donation centres.

Blood bank licenses are issued for five years by the CDSCO and renewed after the state-level Food and Drug Administration recommends renewal. Both the agencies work closely in overseeing the criteria for blood banks and their licensing. In ensuring blood safety, the supply of reagents and other diagnostics necessary for testing are covered under separate guidelines issued by the CDSCO. The guidelines include direction for general equipment and instruments, and detailed records of diagnostic kits and reagents used. Access to safe blood is the primary responsibility of NACO, under the Department of Health and Family Welfare.

Following the National Blood Policy that was launched in the year 2003, an action plan on blood safety was formulated. The objective of the plan was to continually improve and upgrade the availability and safety of blood and blood products, thus building a self-sustaining national blood transfusion programme.

The National Blood Policy 2003 reiterated the government’s commitment to provide safe and adequate quantities of blood, blood components and blood products. The activities and functioning of a large network of blood banks and blood component separation facilities in the country are supervised at district, state and national levels.

What do you have to say about India’s present fragmented blood banking system with over 2600 blood banks? Could you give details of the shortfall?
NACO supports over 1,000 blood banks out of the total 2760 blood banks in the country. In 2015, the annual collection of these blood banks was 6,828,055 units which is approximately 60 per cent of blood requirement.
 
What needs to be done to regulate the blood transfusion sector and are blood banks coordinating for the same?
Voluntary blood donation is gradually showing signs of improvement in India, with transfusion experts and regulators enhancing awareness on the need for blood donation. In addition to enabling access to blood, the blood transfusion community is now actively working on ‘safe’ blood transfusion. Especially in very small blood banks, safety processes and donor screening and counselling guidelines are not followed stringently, putting patient lives at risk.

Transparency, maintaining standards and ensuring quality systems are vital for effective operations of blood banks. There is a need for stringent selection of blood donors with emphasis on voluntary donations and comprehensive screening of the donor’s blood for Transfusion Transmitted Infections (TTIs). There is also a constant demand for higher standards of testing, such as the nucleic acid amplification test (NAT) for screening blood donations, which is becoming the norm the world over. NAT has not yet been mandated in India, but rapid progress is being made towards that end.

It would be a boon to patients requiring regular blood transfusion to have access to international standard ‘safe’ blood, so that they may focus on their ailment without running the risk of any fresh infection from the transfusion.

In terms of assessing the blood quality, how equipped are Indian blood banks for testing?
The Indian blood transfusion industry is not only fragmented, but equally diverse in ownership patterns. From private and corporate to international NGO-run to Government-owned or individual-owned, blood banks are varied in the country. Despite the regulated nature of the industry, the operations and services of blood banks tend to depend on the management and its focus on technology and safety measures.
 
However, there are a few challenges that are common to the different types of blood banks in India . These are quality of screening tests and methods. There is a lack of quality reagents and test kits. In addition there is a paucity of adequate training for hospital staff. Poor laboratory procedures, inadequate basic facilities within a majority of blood centres and lack of awareness on safety amongst blood donors and receivers are the other issues.
 
What is the status of voluntary blood donation and are Indian blood banks stocked with required blood groups?
As stated earlier, India currently requires around 12.8 million units of blood. However, it is heartening to note that 18 states of the country have recorded more than 80 per cent voluntary blood donation. States such as Dadra Nagar Haveli, Tamil Nadu, Arunachal Pradesh, Maharashtra, Haryana, Madhya Pradesh, Uttarakhand, Daman and Diu and Kerala have reported more than 90 per cent voluntary blood donation. However, states like Meghalaya, Manipur, Delhi, Chhattisgarh, Jammu & Kashmir, Puducherry, Uttar Pradesh and Assam reported less than 60 per cent of voluntary blood donation during January to December 2015.

Despite the national average of voluntary blood donation being around 80.5 per cent there is still an unfulfilled need amongst patients that require regular blood transfusion, namely thalassemic children, accident victims, cancer patients etc.
 
In your opinion what are emerging threats of transfusion-transmitted infection?
TTIs threaten the safety of patients requiring blood transfusion, which in turn tends to impact the healthcare economics of the predominantly out-of-pocket market that India is. With TTIs, hospitalisation time and costs correspondingly increase, not to mention the financial loss resulting out of minimized productivity of not just the patient but the care-givers as well.
 
Could you tell us three trends and challenges bogging down the growth of the sector?
 Blood safety is increasingly becoming a widely discussed subject in India. Media and hospital reports of TTIs are fueling the industry to move towards safe blood processes, practices and technologies. Some of the factors behind patients in India being more prone to receive blood that is contaminated with Hepatitis viruses, as compared to some developed nations are: Donation by family/replacement and paid donors, inadequate blood screening and lack of advanced screening methods like NAT and inadequate counselling and procurement of information about the medical history of the donor.

 
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