India has a moral obligation to participate in clinical trials

Milind Rege

The global pharmaceutical business, like any other industry, sustains itself on innovation. Stakeholders in this process, patients, doctors (principal investigators), pharma / biotech companies (sponsors), clinical research organisations (outsourcing partners) and millions of healthcare professionals form the path of innovation. A major part of the process is testing the drug for its safety and efficacy and over the years the drug development industry has evolved to meet the global healthcare needs.

According to various industry estimates, it takes approximately 10-12 years for a new drug to enter the market with more than $1 billion investment. Each drug moving through the drug development pipeline is rigorously scrutinised for its safety and efficacy. Industry estimates suggest that amongst the various costs associated with drug development, the share of the conducting clinical trials is the highest. Be it a commonly used drug like paracetamol or an advanced cancer drug like Trastuzumab, they have all gone through rigorously monitored phases of drug testing.

So, why is this industry, which seems to be a very important part of our lives, not known to us? How many people really understand the process? Where is India on the global clinical research map? Do we have a moral obligation to be a part of it?

Dr Shubhangi Desai

Throughout history India has made notable contribution to the fields of science and technology. Every year hundreds of thousands of new science graduates enter into the workforce and their contribution in the fields of engineering and computer sciences is well documented. However, the same cannot be said about their contribution to the lifesciences. Due to better opportunities in other established fields such as IT, these graduates could not contribute to life sciences. However, clinical research is an area where these graduates can make a positive contribution. Just as IT industry boosted economic growth in the nineties, the clinical trial industry has the potential to create thousands of jobs and contribute to economic growth. Globally, about 20,000 trials are registered in a year. About 90 per cent of these trials happen in the developed countries of North America and Western Europe.

Additionally, there is a well developed regulatory framework for conducting clinical trials which highlights responsibilities of sponsors, investigators and patients. This framework provides strong regulatory oversight and risk mitigation measures to ensure patient protection and scientific and ethical validity of the study. Less than two per cent of the global clinical trials happen in India. Low R&D spend, uncertain IP protection and regulatory uncertainty has contributed to the slow pace of growth of clinical trials in India.

In contrast, the disease burden in India is growing at an alarming rate. As per the latest prevalence data, cumulatively 150 million patients in India are suffering from diabetes, cardiovascular or respiratory diseases. Additionally, another two million patients are reported to have been diagnosed with cancer. The incidence rate of these diseases is also increasing much faster than developed countries due to changes in lifestyle and risk factors such as tobacco use, obesity and stress.

The healthcare facilities in India are woefully inadequate to effectively tackle the growing disease burden. Also, the quality of care offered in most hospitals is sub-par and not necessarily in accordance to international standards. Such a scenario is more likely in Tier II & III cities of India. Also, there is a need to develop medicines specific to the needs of the population of India.

However, since pharma R&D is highly risky, indigenous companies tend to shy away from the massive investments required. This is evident from the fact that filings in the pharma sector annually in US is more than 20 times than that of India despite having a comparable disease burden. We therefore, need to rely on western medications to tackle our healthcare needs. In many instances this is detrimental as the innovator company may launch the drug in India anywhere between two to 14 years after other markets, thereby denying best-in-class treatments to patients.

Therefore, it can be argued that India has a moral obligation to participate in clinical research. By actively participating in clinical research India can make a positive contribution in the furtherance of the pharma sciences. Additionally, during the course of a clinical trial the subjects not only get access to cutting edge medications but also to advanced healthcare modalities which they would not have otherwise got access to.

Conducting trials in India meant better patient reach for global trials and access to cutting-edge life saving drugs for patients in India. Increased patient population for a trial results in quicker enrolment and eventually leads to the drug coming to the drug much earlier. The trials were extended to Asia in order to increase the gene pool and bring data from different parts of the world, thus presenting better results of drug efficacy.

The growth in this industry, like any other commercial sectors, has also created its share of criticism. Clinical trials being an essential step in drug development, regulatory bodies in the US, Europe and Japan have established documented procedures for overseeing and regulating clinical trials. India too is taking steps to ensure that a strong regulatory framework is established to support the growing trends in outsourcing of trials by multinational sponsors to optimise the costs for drug development. With the right regulation India can leverage its deep genetic pool and its ability to provide high quality clinical data by being an active participant in pivotal trials. Many rare diseases or cancers require treatments that are well beyond the reach of the general public even in western countries. The only point of access for such medications is clinical trials since many of them are awaiting marketing approval pending submission of data.

Finally, we must also ask ourselves the question whether we are willing to consume drugs that have never been tested or inadequately tested on Indian population.