Robust Regulations, Skilled Professionals, Diverse Patient Pool: Why India Is Becoming Hub For Drug Trials

Looking Ahead, India@2047: The Covid-19 pandemic has re-emphasised the importance of high quality drug trials and India is fast emerging as an attractive destination for global pharma companies.

The Indian pharmaceutical market is expected to grow from its current level of $44 billion to $130 billion by 2030

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At a time when several infectious diseases are emerging and different variants of coronavirus are popping up across the globe, high quality clinical trials have become critical for pharma companies to ensure the efficacy and safety of a drug before it is rolled out for the public. Even the paracetamol that we pop today when we have fever underwent clinical testing for more than 50 years before being available for commercial use in 1950 in the United States.

The Covid-19 pandemic has re-emphasised the importance of high quality drug trials and India is fast emerging as an attractive destination for conducting global clinical trials.

Why India Is Emerging As Prime Destination For Clinical Trials

A robust regulatory framework on par with the US since 2019, vast pool of patients, skilled medical and paramedical professionals and low cost has put India firmly on the global clinical trials map, according to experts.

"India is emerging as one of the most preferred destinations for drug trials on account of it being the largest pharmaceutical industry. And if you have a large pharma industry, more clinical trials are bound to take place," said Dr Dipak Shukla, Director, Pushpawati Singhania Research Institute (PSRI), while speaking to ABP Live.

The Indian pharmaceutical market is expected to grow from its current level of $44 billion to $130 billion by 2030. It is growing at a CAGR of 12.3 per cent, which is much higher than any other industry at this point of time, according to Economic Survey 2020-21.

Sanjay Vyas, Managing Director India, at Parexel, an US-based clinical trial organisation (CRO), said a diverse pool of patients on account of India being home to 1.2 billion population, subject matter expertise and trained English-speaking investigators are other contributing factors.

According to the Clinical Trials Registry India (CTRI), India approved over 100 global clinical trials in 2021, the highest since 2013. Even in 2020, the year the Covid pandemic struck, India registered 87 global clinical trials. The year 2019 saw 95 clinical trials being conducted, while there were 76 trials in 2018 and 71 in 2017.

New Drugs and Clinical Trials Rules Ease Approval Process

The surge in number of applications came after India enacted the New Drugs and Clinical Trials (NDCT) rules in 2019, which aimed to promoting clinical research in the country and faster accessibility of new drugs to the Indian population.

The guidelines reduced the time for approving applications to 30 days for drugs manufactured in India and 90 days for those developed outside the country. Besides, additional safeguards for patients in cases of adverse events has made the process more transparent.

Dr Ganesh Divekar, Vice President (Clinical Operations), at SIRO Clinpharm, one of India's oldest clinical research organisations, said the clinical trial approval and review process had become more transparent and predictable. "The ICMR has also come up with disease specific guidelines, which is very helpful from treatment and formulating clinical trials perspective," he said. 

Sanjay Vyas of Parexel said the regulations in place today were at par with guidelines of US Food and Drug Administration (FDA) or European Medicines Agency (EMA).

"There was a time in 2000 when India lost a lot of opportunities in clinical trials because of non-compliance issues due to some local providers not following the code of conduct. Patient recruitment became an issue and many companies went away because regulations became totally different for new therapies to come into the market," Vyas said.

"Finally, in 2019, the DCGI came up with fantastic regulations that are pro-clinical trials. They not only support the patients, the pharma companies but even the service providers, making it a win-win situation," he added.

How Covid Added A Feather In The Cap Of India

While clinical trials became negligible when the pandemic struck in 2020, it triggered a conversation around clinical trials. The pandemic created an urgent need for treatments and vaccines, owing to which a significant number of clinical trials were performed in the country after 2021.

"Suddenly everyone was talking about what a placebo is, what clinical trial conduct is, what epidemiology is all about. Covid-19 has brought more awareness about clinical trials in India," Vyas said.

Dr Shukla of PSRI said vaccine testing and processing had become fastest in India during Covid-19. "It has established the capability of the Indian pharma industry to conduct clinical trials in a very speedy and in the most ethical way. It has added a feather in the cap of India, which was already becoming a hub of clinical trials," he said.

According to Dr Divekar of SIRO Clinpharm, the silver lining of the Covid pandemic was that it brought in more belief in hybrid or de-centralised clinical trials.

"During the pandemic, hospitals were busy treating Covid-19 patients. It triggered the use of decentralised trials or what we call as direct to patient. Instead of having the patient coming to the investigative site at the hospital, we thought of innovative ways of having the trials at home," said Vyas, who is also the executive vice president at Parexel.

Challenges That Still Persist

However, there are several bottlenecks that India needs to iron out if it wants to compete against developed markets in the United States, Western Europe, Germany, and Japan, which generate the lion's share of clinical trial activity.

Shukla opined that there needs to be a culture of research in the country and the private health sector should be roped in.

"In India, 80 per cent of the health sector is private. The private sector health services are more commercially orientated, they are not much inclined towards academics and research. Presently, most of the clinical trials and research work is carried out by institutions like Central Research Institute, PGI Chandigarh, AIIMS. But their number is so minuscule, they do not constitute even 1 percent of the research work in the country," he said.

Sanjay Vyas pointed out that most of the infrastructural development in terms of hospitals and investigative sites have taken place in Tier 1 and, to an extent, Tier 2 cities. "If we have to make sure that therapies reach the innermost areas of India, a lot of infrastructural development has to happen," he said.

SIRO Clinpharm's Divekar, however, stressed that the regulatory environment could be made more transparent "if we compare the same against western world". "Acceptance of foreign data for product approval or for Phase 4 study conduct can be explicitly stated in regulations," he said.

Major Areas Of Innovation In Terms Of Clinical Trials

Clinical trials in India are at present going on in diverse fields, with the highest number of studies being done on oncology and public health issues.

SIRO Clinpharm is focusing on oncology and immunology as major areas of innovation as these diseases still don't have expected treatment options, and there is scope to improvise upon.

Dr Shukla of PSRI said clinical trials in public health issues were again coming up after Covid. "At one point of time, we thought malaria-free India would be a reality soon. But now, malaria is resurgent, and dengue is coming back. This indicates there will be a fresh surge of clinical trials in research in the public health domain also," he said.

With the clinical trials market pegged at $80 billion globally, Sanjay Vyas of Parexel feels it is a huge opportunity for India to become a powerhouse for clinical research-led healthcare advancements.

"There was a time when India was always known to be the 'back office' for everything. But now we are seeing a big shift, India has technically become a frontrunner in clinical trials conduct," he said.