International Clinical Trials Day Special: Can Indian clinical research industry regain its lost glory?

New Delhi: Who would have imagined that a flourishing clinical research industry in India less than a decade ago, would just fizzle out despite India’s rising scientific and healthcare prowess?

From 2005 to 2010, the industry was booming with the business. There was enough work for both matured and fresh Clinical Research Organizations (CROs). The number of global clinical trials were rising and the industry expanding, making the global players and investors look at India as a potential big-ticket market. However, in between 2010 to 2013, there was the huge twist in the tale. The huge outcry and bad publicity over a few death cases due to a number of factors (both negligence of few industry members as well as overhyped false cases), made the entire industry suffer.

The larger negative public opinion generated through political rhetoric, allegedly biased media trials and unwanted judicial activism led to the demise of a young industry. The fluctuating regulations added to the uncertainty. As a consequence, India was no longer considered to be a favorable place for carrying out trials.

Coming back to the current scenario, while things have moved a bit in last two years due to few new initiatives to help streamline the regulations, there is a lot more to improve the outlook. Contrary to the claims that might be made about the extremely positive environment, the underlying fears and misconceptions over clinical trials continue to prevail. The mainstream media have now toned down a bit on its blind criticism, but activists still are on an oath to chase what they perceive as an evil industry.

Now we all know that the scientific claims on the discoveries and inventions can be of any benefit to the masses without the actual product development and testing on the said population. Therefore, is it fair to treat the clinical research as something as necessary yet always look at it with suspicion?

Statistics don’t lie 

Let’s take a look at the statistics. Between 1998-2009, the golden period of clinical trials happened in India, making the country a kind of hub for such activities. The trained resources and comparatively cheaper operations caught the attention of global pharma giants.

The clinical trials that were registering an increase till 2010 came down to merely 480 trials (with 253 approved) in 2012 and further to 207 (with 73 approved). In 2013, it scaled down to two figure statistics.

Yet there is a silver lining as the industry has slowly got up on its feet again.

There has been a gradual increase in the number of clinical trials in India, especially in 2018. The number of global clinical trials approved in India during 2013, 2014, 2015, 2016 and 2017 approved by DCGI are 17, 70, 54, 37 and 97 respectively.

Despite the above negative or positive figures, we can’t ignore the fact that while India has the highest disease burden in the world yet less than 1.3% of global clinical trials take place in the country.

Reversing bad reputation

The CRO business in India owes its negative perception mostly to the bad press. It has been far demonized in the public psyche as a mean business with no human values. Both far right and far left political activism has created a cloud of doubt on its real value for the medical and healthcare industries.

Now, if the reputation has to be regained, it is important to demystify it. There is a need to be better at educating the general public about the role and relevance of clinical research in the country as also the rights and responsibilities of clinical trial participants. The media can play an important role in supporting this.

Regulatory hassles not over yet

Some of the clauses of ‘The Draft Clinical Trial Rules 2018’ that was published earlier by the Ministry of Health and Family welfare earlier this year for consultation has made the industry members worried about future.

As per Mr Naz Haji, Managing Director, IQVIA,”We are hopeful that the regulators will relook at some of the clauses of the Draft Rules that could act as deterrents to doing clinical research in India. This could be done while ensuring that patient safety, confidentiality, and quality are not compromised.”

“Lessons from the downturn of a few years ago have shown us that restoring confidence is a long drawn out and arduous process. We are still recovering from this period and any further setback will hurt our image further and seriously impact India’s ability to attract clinical research into the country. The most affected by such decisions will be patients who will lose out on access to safer and more effective therapies, and our healthcare system which will be further burdened by increasing costs,” added Mr Haji.

“New Draft Rules on Clinical Trials have certain contentious clauses for e.g., based on the Ethics committee’s decision, providing an interim compensation of 60% that is non-refundable, or providing medical management and ancillary care for as long as required, whether the adverse event is related or not to the clinical trial,” says Mr Chirag Trivedi, President, Indian Society for Clinical Research (ISCR).

“We have given our recommendations for these critical observations to various authorities,” Mr Trivedi adds while warning that if these rules are notified as is in the current draft, then it has the potential to derail the conduct of global clinical trial in India and it will take India back to 2013 days, wherein the global sponsors (including leading academic institutes) will not want to conduct clinical trials in India. “This will have a direct correlation of these drugs not being introduced in India and our patients will get impacted by it,” he says.

Dr Renu Razdan, Senior Vice President, JSS Research is optimistic. “The constant improvement in the regulatory scenario for the conduct of clinical trials is a welcome move. We see a lot of time-bound decisions being taken by the offices of regulators,” she says.

Is the future bright or we are over-expecting?

The future of clinical research sector in India looks optimistic. The huge investments in research and development of new drugs coupled with growing demands of huge diseased populations will eventually lead to the need for bigger and better clinical trial settings.

“There are significant opportunities in terms of Data Management, Statistics and Medical Writing. Large captive centers have been opened here by large multinationals like Novartis. There is a very attractive significant pool of young men women who contribute significantly to drug development process for these large multinationals. With the advent of personalized medicine and digital healthcare India should be able to tap these opportunities as well,” mentioned Dr Renu Razdan.

Mr Naz Haji agrees. “There is a growing trend towards using analytics and technology to deliver more precise and insightful clinical outcomes and we see that happening in India as well,” says Mr Haji.

One thing is clear. The clinical trials can’t be wished away but it’s anomalies and lacking factors can be. The only way that could make the clinical research acceptable in a country like India is the awareness programmes and show of integrity by the professional CROs. The industry has to ensure that it will follow the guidelines and identify the back sheep who due to their actions bring disrepute to it, the government too has to ensure that it deals firmly with the scaremongering. Awareness about the importance of clinical trials as a part of drug discovery process has to be made known to public through workshops and appropriate forums.

Hope the tiny little industry survives for good. After all, when there is a talk of precision medicines and making India a global pharma hub, the clinical research can’t be sidelined for the sake of few misguided versions of truth about the industry.