The Indian clinical research market: Weighing the pros and cons
Globally the clinical research industry has become a thrust area primarily for the development of new drugs. The fervor to invent increasing number of drugs has given rise to various advantages as well as disadvantages in the clinical research market. We weigh the challenges and opportunities the industry faces today.
Currently, less than 2 per cent of clinical trials are conducted in India and Asia Pacific countries. India has seen a real slow down in 2011 due to slow down in regulatory environment. “Last year the registration of studies was close to 90,000 and approximately 800 studies are registered in clinical trial registry managed by Indian Council of Medical Registry. A country with over one billion people conduct only less than 2 per cent studies,” informs Dr Krathish Bopanna, President & Executive Director, Semler Research Centre,Bengaluru. Making addition to this he says, “It is high time media plays a vital role in educating public that we need quality research in Indian patients.”
Today, a number of factors favour the clinical research market of India. One of the biggest advantages is that today India has numerous government-funded medical and pharma institutions with state-of-the-art facilities. These facilities help serve as centres for various form of clinical trials. Also, India has a chain of well-trained and qualified manpower in terms of doctors, technicians, scientists who are well versed in English. “India has great potential to grow in research. It could be education, speaking abilities, quality of research hospitals, good pool of skilled researchers, huge disease burden, which can be used to regenerate ideas for the clinicians to treat patients,” says Dr Bopanna.
India is also blessed with a huge patient pool, which makes clinical research a lot easier and is definitely one of the major reasons behind the growth of India in the clinical trials space. Cost is another aspect that has been a helping hand in the growth of this industry. The cost of conducting a trial in India is estimated to be 50-70 per cent lower than that in the US or UK. The cost of research and development is also less in India as compared to the US and UK – this low cost further helps in attracting people from various countries not just for the purpose of clinical trials but also for developing new drugs.
Due to these factors the success rate of the clinical trials conducted in India is high. “Once a candidate molecule enters the clinical stage its rate is high. It is further high when the lead substance enters phase IV. It is difficult to give the precise numbers on the success rate. However, the success rate varies from one disease to another. But the overall success rate has been high in India,” explains
India v/s other nations
China is far ahead of India as far as clinical research in concerned as they have attracted huge investments from big pharma companies, and is today emerging as one of the top five destinations for clinical research; the market too is growing at a phenomenal pace. “China is the biggest threat to India in clinical research domain in the Asia Pacific region. According to data released by the US National Institutes of Health, India is hosting around 1,500 trials compared to the 7,400 trials in China,” emphasises Avadhut Joshi, AVP – Business Development, Clinical Research & New Project, Metropolis Healthcare.
Other countries such as Russia, Turkey, Brazil, Korea, Germany, Canada, Japan too have progressed very quickly as they have systems and processes, which facilitate and promote young and inspiring minds to work and flourish. “We need a rapid change in our attitude and once we change our mind, we can progress rapidly. There is a serious doubt in our minds that we are not doing things in the right way, and if so, reformation in policy is called for. We cannot show a transient path with old system of identifying and resolving issues,” informs Dr Bopanna. In addition to this, commenting on the difference between the clinical research market in India as compared to the other nations he says, “We move three steps forward and six steps backward. Last two years have been the worst period for clinical research in India. We have gone from bad to worst and we started asking whether we are in the right track. It is the lack of progression among the stakeholders that includes regulators, government bodies, NGOs, media who have failed to understand the rigour in which clinical research is conducted. They have accepted the myth that Indian patients are guinea pigs. Unfortunately, no one has gone to the depth of understanding the realities and how it is going to get benefits.”
Roadblocks to conquer
“The systems and processes are not in shape; as a culture we want to do many things at a time. We need to put systems and processes in place so that we do not become targets for wrong reasons. We need to learn from the West, and all we need to follow is one established system and practice. Just by working on this, we will be able to find the right results and it does not require great minds to put systems and process and it is always application of right mind at the right place,” says Dr Bopanna. A few other challenges that India faces today is the stringent and lengthy approval process. The time to get approval for a clinical trial takes 3-6 months and in a few cases even more. This needs to be looked into as it is depriving the industry of critical time.
Another important aspect is the lack of availability of clinical trial institutes. Regardless of the availability of infrastructure and manpower, clinical research is still considered to be in its infancy in India, this is due to lack of infrastructure. A need for development of special institutes for clinical research practices have been felt as it will also help in delivering right education and practical experience to the youth.
With the help of the government and regulatory reforms, in a few years India will be in a position to increase the number of clinical trails being conducted in India. “Today, several contract research organisations are looking forward to partnering with biopharmaceutical companies so as to offer solutions from development to marketing. This will definitely be a major growth factor for the industry in 2012,” believes Joshi.