Interview

15 percent of global business will come to India

From starting India's first clinical research training institute to introducing the concept of Site Management Organisations (SMOs) in India, Shiv Raman Dugal, Chairman, Institute of Clinical Research (India) (ICRI) has seen the evolution of this industry. Excerpts from a conversation with Arshiya Khan

"Let's worry more about quality of what we teach and less about advertising. It is not important to place a full-page ad, but important to do some good quality teaching. Because people are aware about the market now, you don't have to tell people what is clinical research. That's a job, which I have done for everybody. So whoever is coming next let him focus on quality teaching, quality work" - Shiv Raman Dugal Chairman ICRI

How has the clinical trial business picked up in India?

In 2003, when I first attended international events like CPhI and Drug Information Association (DIA), there was not a single stall or booth for clinical research. And when I spoke to Clinical Research Organisations (CROs) they were not interested in speaking to anybody from India on clinical trials. The objection, which they raised was lack of manpower. In 2004, a UK based company was interested in giving a 2,500 patient major trial to India. They nearly gave the business to me. But before giving me the business, they decided to send their Clinical Operations Director, to India, to study how the clinical trials market in India operates. And I took them to a leading institute of this country, in Delhi, which was the home of clinical trials and to some of the leading names in the clinical trial industry. By evening, the person was horrified at the state of India's clinical trials industry. There was lack of knowledge and lack of trained manpower. So training people was the top most priority.

In those days I also took her to one of the topmost central labs. They did not know what CAP was! Mind you I am not talking of the low down staff, he was the head of the division. And therefore they were not in a position to use those central labs. Both these labs are now leading central labs.

That's when we set up Institute of Clinical Research (India) (ICRI) in March-April 2004. To help us get the syllabus we got in touch with the top people from All India Institute of Medical Sciences (AIIMS) and the Indian industry. And we based our syllabus on UK's Cranfield University and certain universities in US.

When we started in 2004, the value of the industry was hardly Rs 20 crore and there were hardly any commercial clinical trials ie. Phase I, Phase II, that were going on. The only company doing commercial clinical trials was Quintiles. And there would have been not more that 25-30 clinical trials which were on at that time in this country. In comparison, in 2007 there were more than 286 clinical trials in this country. This year there are more than 483 clinical trials all over in this country. Excluding data management, the industry is worth around Rs 1000 crore this year. That means each trial is roughly worth about Rs 1.5 crore. Clinical trial data management in itself is today worth about Rs 1000-1500 crore. As of now, clinical data management is reported under IT instead of pharma and clinical research. So this is where the industry has reached.

Our first batch was of 100 students. I was told they would never get jobs. I was also told that not only will they not get a job but the Institute will close down. We placed 100 percent of that first batch. Three years later, there is not a single student, who earns less than Rs 60,000. And today we have more than 2000 students who pass out from institutes all over India. And I can say with reasonable amount of confidence that about 85-90 percent of them want to work in the clinical trials industry. It is very difficult to find people in the clinical trials industry and if we did not have an institute it would have become difficult to find people. And therefore if more people get into the business I don't see a problem. I think there is enough scope for many people to get into the business. My only suggestion to other people is that let's worry more about quality of what we teach and less about advertising. It is not important to place a full-page ad but important to do some good quality teaching. Because people are aware about the market now, you don't have to tell people what is clinical research. That's a job which I have done for everybody. So whoever is coming next let him focus on quality teaching, quality work.

As far as our Institute goes, we grew from about five full time faculty members, to now having the single largest faculty in the world in clinical research. We have more than 50 full time faculty members. We probably have the largest collection of MDs in pharmacology in the world working in one location. We are also ahead in terms of the number of students.

Going ahead, where will India figure in the global clinical trials market and why?

There are four trends that have taken place in this country in the clinical trials industry. First, the US Food and Drug Administration (FDA) has decided to increase the number of patients in Phase I and Phase II trials. The reason they are doing it because of bad experiences with certain drugs which are coming to light now and there is a need for safety as well.

Second, the total number of trials is more than 18,000 globally. Considering this, even if there is a requirement of 500-600 patients per trial then you talking of over eight to nine million people on trials. Actually the number of patients required is much more. Today most trials require more than 1000 patients. That means you are talking in terms of eight million patients in the western world. Eight million people in a population of 300 million, which is the population of the US. Out of that 300 million knock of 70 percent (kids and others) and you are left with approximately only 100 million. That means out of every hundred (100) people, one is on a clinical trial today. So it is difficult to get patients.

Third, the Indian market is become interesting, as there is more than $76 million business in India. Fourth, Indians speak English. And fifth, there is a lot of hype about India. Everybody thinks that India is a great destination, it has great people etc. All these things and advantages put together, pharma companies are forced to look at India. At present all the research is being done by MNCs, and this will not change for a few years. Very little research will be done by Indian companies. Only about ten percent of global research will come from India, at least for the next 20 years. 90 percent of the research will be done by global pharma. And what are we going to do? Global pharma is now being forced to look at India, because of these four five reasons, therefore the business has to come here. And it will continue to grow at more than 100 percent. Therefore 15 percent of the global business will come to India in the next three four years. It's not that they love to give us the business but because they don't have an option. We are the only location left who can give them patients, otherwise it is China. India and China are also the places from where they are going to get their future pharma business from. And in case of South Africa, you have a huge continent that you are trying to cover, but there is sparse population, there is not much money, and very few people speak English. So India is the best option because it is balanced. China is considered as a manufacturing center.

How does the concept of a Site Management Organisation (SMO) work?

There is a pharma company at the top. That's the sponsor, who gives the trial to a CRO. The CRO will give the trial (medical functions) directly to sites, with investigators, who are GCP compliant and capable of conducting trials and willing to follow instructions. It can therefore use an SMO to manage these sites. There will be a requirement of three to four sites to get 300 to 500 patients. To get out of this problem, one would need five to six SMOs. That's where the concept of an SMO comes into play. There are quite a number of pharma companies who would like to do monitoring themselves, instead of a CRO. Such pharma companies will also prefer an SMO. Besides, SMOs only do certain things. They can only add patients so you cut down on your travel costs and insure a certain amount of compliance.

So what's likely to happen in future is that there is going to be a collection of sites. Similar sites getting together, forming a pool to conduct trials.

How has the concept of a SMO kicked off in India, and who are the players?

SMOs are going to stay in India as they are in US, because of the geographical diversification of India. Secondly, there is training and communication problem. So SMOs are likely to be successful in this country.

We at IRL (ICRI Research Private Limited), an associate of ICRI, have a set of sites, which are owned by us and do not charge extra for management services, whereas, an SMO would charge for management services. And this is the trend I see in the future. Groups of sites, which are owned by one organisation. IRL has nine sites, which are owned by it. Therefore it offers dedicated clinical research services, faster and larger number of patient recruitment, better quality of data at the same price as other sites, which is advantageous. But what is going to be successful is the concept of group sites. At present only IRL follows this concept. But in the US, grouping of sites is very common. It gives you one agreement, saves time, gives better data, is GCP compliant, cost effective etc.

What are the concerns faced by an SMO?

The SMO must ensure that sites follow Standard Operating Procedures (SOPs), ethics and are GCP compliant. If there is an adverse event the SMO has to report it to the pharma company, who takes the decision to stop the trial or not. It also has to be sent to the ethics committee. And if there is carelessness the SMO will be responsible.

What are the infrastructural problems that India faces with regards to conducting clinical trials?

Firstly, investigators are not GCP complaint or certified. Secondly, there is a lack of understanding on how to recruit patients. Thirdly, each location has its own ethics committee, instead of a centralised ethics committee, which makes it very complex. This means that we need to go to each site to get approval. This is a system unique to India, whereas in the US and other countries, they have centralised ethics committee. The lack of uniformity in the ethics committee is also a concern.

There is a debate about illiterate patients being recruited without adequate knowledge of the process. How will it impact the industry?

That's bull shit. The one who is doing it should be prosecuted.

With tropical diseases taking a toll in the under developed parts of the country, how do SMOs recruit patients in these areas?

In developing countries and rural areas, the patient being recruited may not understand the language in which the consent form is printed. Then the investigator has to take his consent in the presence of a local person, who understands the form and explains it to the patient/ volunteer.

Tropical diseases are taking a toll and hardly any work is being done by pharma companies but it is being done by institutes and NGOs. Because pharma companies are now taking interest in these diseases.

At the end of the day, pharma companies also look at revenues. Because if the market is only in less developed countries then pharma companies may not be interested. Then it has to be an effort, which has to be done by NGOs or by government. The government has to take an initiative, because private players are not in the business for charity. Let's say if a drug has to be discovered, it is a $1 billion expenditure. And if the total value of the drug is only one million a year then it is not worth it. So it has to have a sufficient weight for the pharma company to atleast recover the cost. Public Private Partnerships (PPPs) may work, but I think it will be the NGO private partnerships that will work. And public sector also has to finance and government can definitely be a good partner. There is good work being done by tropical disease institutes both in India and in UK. Lots of work is being done and funded by Welcome Foundation on tropical diseases. Even the Bill and Milinda Gates Foundation is working in the same area. It's not that work is not being done, there is work being done but the funding has to be in a different manner. It has to be some sort of partnership, because funding cannot be by the private player totally.

Which are the therapeutic areas that CROs are now focusing on and why? Which therapeutic areas has IRL covered and which are the others in the pipeline?

CROs are focusing on cancer, psychiatry, pain management, depression, and sleep management. IRL is present in all these areas, except psychiatry. We have a site and we are planning a trial.

Can you update us about the recent developments, expansion plans at IRL?

We are starting up four sites in the US and more in India. These are all power sites. So we have a group of sites. And we continue to function as a group of sites. Part of these sites, in the US and Singapore, will be funded locally through private equity (PE). We are raising close to about $10 million with PE players from abroad, who will be our partners there in South East Asia. And in India we will do it on our own.

arshiya.khan@expressindia.com