Shahid Akhter, editor, ETHealthworld spoke to Sumit Bagaria, Managing Director & CEO, Hemogenomics, Bangalore to understand the gaps in blood safety standards in India.
Tell us about the current trends in blood banking in India.
Globally, blood banking is centralized. If you look at South Africa, it has 3 blood testing sites, 7 processing sites and maybe 80-90 collection sites and 80-90 distribution blood banks. In India, we have 2900 or more blood banks, so we have a highly fragmented blood banking system. Also, we have multiple formats of blood banks- government blood banks, hospital blood banks, stand-alone blood banks – many of which are doing social work like Rotary, Lions or Jan Kalyan and we also have some commercial blood banks.
India collects between 11 and 12 million blood units a year, which is a large number. Each blood bank is small and there are both city based and rural blood banks. A city like Delhi- if I put that in the perspective of calling it NCR, has more than 60 blood banks. If you compare that to 3 in South Africa and around 4 in Australia, you see the difference in terms of different types of blood banks.
You could have a corporate hospital blood bank like Apollo, which gives the highest standard available globally or you may have a small rural blood bank or a Government blood bank that still does rapid testing or they don’t break blood into components- red cells, plasma, platelets. All over the world, components are made, but In India, only 40 % of the blood banks are doing that.
I think India has moved to the best of technologies but only in Tier 1 cities, in some of the corporate hospitals and some large Government. hospitals. The rest of the industry is way behind.
Your views on the current blood safety standards in India and the challenges related to it?
Recently, in September 2016, there was a 9 year old child who had cancer and got HIV infection through blood in a Cancer Hospital in Trivandrum. Amitabh Bachchan, one of the biggest Bollywood celebrities, got Hepatitis B through blood. So whether you are a little child or you are a man who is the King of Bollywood, you can get infected through blood ! A recent report by TOI states that- Over the last 11 years, over 20,000 infections of HIV have passed through blood. And this is just HIV- if we add Hepatitis B and Hepatitis C, Hepatitis B being much more prevalent in India, the numbers would go to about 100,000 or more! Even though the blood safety scenario in India has improved dramatically over the years- ever since NACO started funding HIV prevention by giving kits, etc. to blood banks, it is still very poor as compared to the rest of the world. We have children getting infected, Thalassemics, Cancer patients and this is because we don’t have voluntary blood donors, we don’t keep proper records, our screening methods are poor, but more importantly, we use very outdated technologies- ELISA kits that are second or third generation and sometimes rapid kits. It doesn’t matter if you are rich or poor, old or young, we could all get infected though blood. If I was to put that in perspective, we need to fight for voluntary donors. But in the scenario where culturally and socially it is difficult to convince a lot of people to voluntarily donate blood, we have to go to technology. One of the technologies that have come around is called Nucleic Acid Testing. In Nucleic Acid Testing or NAT, we catch viral RNA or DNA, multiply it billions of times and then detect it. So if I give you an example of Hepatitis C, where the window period (which is the time between when you got infected and when it is detectable) was as high as 2-3 months, with NAT it has come down to 2.2 days. I think a technology like NAT can play a big role in making blood safe in India.
What is the current status of Nucleic Acid Testing in India? How is it different from the developed world?
Nucleic Acid Testing started because of HIV transmissions happening through fractioned units like Albumin, Factor VII, Factor VIII etc. From 1999, testing with NAT has been there in the USA and Germany and gradually it has gone all over the world. An example of South Africa becomes very pertinent- where when the black integration happened with the whites and they wanted blacks to donate blood, having almost 20 % infection of HIV amongst the black population, they had no choice but to bring a technology like NAT. From Day 1, all blood was tested individually by NAT in South Africa.
Today, Northern America, almost all of Europe and Asia (I would say only India and China are partial testing)- almost every other country in Asia is doing NAT including Sri Lanka. Let’s leave Bangladesh and Pakistan out of the scenario.
So, globally, blood safety is so important because prevention is something that no one wants to give an option to. Countries like the US, Australia, Singapore, Hong Kong have mandated NAT- made it compulsory. India has left it open ended- “If you want to do it- you do it.” Therefore the adoption of NAT is that India has only been about 7-8 % of the total amount of blood in India that is tested by NAT and only the people who can afford it- corporate hospitals and some Government hospitals are doing NAT today.
You mentioned about individual donor testing and pooling. How do they differ? What is advisable for India?
When NAT started, it was being done for fractionators and they were actually doing pools of 516. The American Red Cross, in 1999 started with pools of 96. That was also because they didn’t have automated instruments and they had to find solutions which were cost effective, taking into account space, manpower, etc. They found that infections were still passing through and moved to pools of 16. If I explain individual donor testing and pooling, an individual donor means every sample collected from a donated unit of blood is tested by one test. While pooling means you take blood samples from multiple donors, mix them together and then test. This creates dilution but makes it cheaper. Unfortunately, companies that are offering pooling, have not dropped the costs down in multiples of the donor size. So if a pool of 6 is being done, the cost per donor should be 1/6th or 1/5th but it is only about 20 % lower.
In India, say we are picking a 1 in 1000, you would miss out 20 % of those. So if we are testing 10 million units, we are going to miss around 200 of those every year to save a little bit of money.
If you look at Individual donor testing, especially for Hepatitis B (which is a major problem in India and most of Asia), countries like Japan, Korea, Australia, Singapore, Hong Kong, Indonesia, Malaysia have all moved from pooling to individual donor testing. Even countries like UAE (Dubai), Saudi Arabia etc. where so many Indians, Pakistanis, Bangladeshis are there, have moved from pooling to individual donor testing. In India, the laws are not clear. If you look at the regulator, he has not provisioned for what you need to do. It is left up to the user. Among the users, a large segment which is stand-alone blood banks only look at the cost. So clearly, there is lack of education and there is lack of awareness. Even when you look at the government policies, the NBTC has a reimbursement policy which controls how much can you charge from a patient for a unit of donated blood. They have put individual donor and pooling at the same price- they should have made pooling 1/5th or 1/6th the cost. I believe that Individual donor testing for high prevalent countries like India and most of Asia, South Africa, etc. is an absolute requirement!
What according to you is the way forward in Blood Safety?
The way I look at moving forward is that there are two or three important things that we can do. One of them is the role that the government needs to play to give more importance to regulating blood safety and supply. We cannot have 2900 blood banks. We need to mandate NAT, we need to ensure better technology, more voluntary blood donors, better screening standards. We cannot let infections pass through. So one side is the regulator and the other side is to get more and more voluntary blood donors. I think today we have social media, mobile phones, technology to go to the young – To go to school and college kids. In South Africa, 50 % of the blood comes from people below 25 years of age and I think these people today can be targeted to become voluntary blood donors. We can also use technology-we can use smart phones, we can partner with Uber, Google, etc. to motivate people to voluntarily donate blood. Hopefully we can link it to AADHAR from both the record keeping point of view and when did you last donate blood; geographical- GPS positioning, if I need blood in AIIMS, let us find someone 2 kilometres away rather than calling me when I am in Cochin. So I think technology, getting the youngsters involved, the government having a direction – The NBTC doesn’t have teeth right now- so I think a mix of those three will go a long way in making blood safe in the country.
What made you think of Hemogenomics?
Hemogenomics was born out of a problem that happened in my family. My brother got Hepatitis C infection. He got infected in 1981 when he had an accident but we found out in 2000. The first round of medicine did not work. My uncle knew Dr. Rutter of Chiron who had discovered Hepatitis C and invented the Hepatitis B vaccine. We went to California, to Emeryville, and sat down with Dr. Rutter to see if he could help, because he held the IP, to know where drug trials were going on for Hepatitis C and whether my brother could get a better drug. That’s when I saw posters of NAT and I asked them what it was – they told me that it’s a screening technology to make blood safer by reducing the window period. I asked- “Why can’t we bring this to India”, and they said “No, it’s very expensive.” Then it struck me- If my brother can get Hepatitis C, if Amitabh Bachchan can get Hepatitis B , then why should they not do it in India. It took us a few years to convince them, to bring the cost down, to bring it to India- They forced me to take up the product. I had no experience in blood banking or diagnostics but in 2003-2004, we did a multi-centric study at Apollo Hospital, Delhi. We found out that almost 1 in 1500 infections were missed by the current serology (ELISA) method. Since we started business in 2006 at Apollo Delhi, today we have over 35 sites doing NAT testing and over 100 blood banks, whose blood we test. In India, in total about 1 million units are being NAT tested.
How do you see Hemogenomics as a differentiator?
One thing is that we are passionate about what we do. We have been at this for the past 12 years- most companies would have added 20 products, to make short term money but we stuck to this. Though it takes time, its capital intensive- we have to place the equipment, we have gone and changed the model. We have given help by putting technicians to run the tests for hospitals – we have done a centralized testing where for small hospitals, we are picking up samples and testing those at centralized sites.
I think we are innovators in saying that we want blood safety to be there and we will find the solutions for you if you don’t have the space, if you don’t have the capacity to test volumes, if you cannot do it yourself. At government blood banks, a lot of times the machines don’t work because the technicians are not there. In dengue season, our people have sometimes worked 24 hours to give results in a certain time. So I think we believe that the safety of blood comes first and we will do what it takes to get there.
What are your future plans?
In future expansion, there are two sides to it- one is the blood banking side and the other is other types of screening. In blood banking, we are now aggressively trying to partner with state governments, to make it more available in the areas that need it, there is less knowledge in smaller areas and therefore more infections happen there. We are talking to thalassemics and others for NAT. We are also talking about getting into Cancer screening. We are planning to start with Cervical Cancer, and hence basically focussing on women’s health. Cervical Cancer is one of the most treatable diseases if caught early enough. So with a combination of liquid based cytology and HPV or Human Papilloma Virus screening, we believe that we can have an algorithm where over time, multiple women are screened. So once they are screened, may be for the next 5 years they don’t need any screening and we can reduce the burden of Cancer treatment. I have actually walked the halls of Tata Memorial Hospital, Mumbai and sometimes you feel like crying when you see so many people with cancer, lack of money, families get wiped out and many of them cannot get treated- sickness and death. So blood screening for me came from my brother’s issue, now, I have seen family members, I have seen Cancer patients – I want to make a difference!