Clinical trials in India grow 10-fold post pandemic
India was high on the radar of companies till 2009, when there were more than 300 studies happening in India, but that changed due to compliance challenges and non-ethical behaviours of some entities who didn’t understand the importance of clinical trials
PremiumIndia has emerged as a key destination for clinical trials in the wake of the pandemic with the numbers registering a 10-fold increase in the past three years, said a top executive at Parexel, India’s largest clinical trial firm.
“We are now almost in double digits, like in the last two years, you saw more than 80-plus clinical trial applications were approved. The database is out there. So, how we went from merely 10-12 studies to this sheer size in the last three years has also been pretty fantastic. So, I believe there is a silver lining. I am very optimistic in that perspective," said Sanjay Vyas, managing director, India at Parexel, one of the world’s largest clinical research organizations (CROs) based in the US.
Vyas added post-pandemic, immunomodulatory therapies, oncology, respiratory, cardiovascular, vaccines and future of rare diseases have become a strong focus for pharma companies. “They have started investing aggressively in research & development at both the global and India level," he added.
India was high on the radar of companies till 2009, when there were more than 300 studies happening in India, but that changed due to compliance challenges and non-ethical behaviours of some entities who didn’t understand the importance of clinical trials. Things started to turn favourable after regulations were brought by the Drugs Controller General of India (DCGI).
“Today, if you look at rare diseases, orphan drugs, if the DCGI does not report, it’s a deemed approval right for the clinical trial application (leading to no delay). The clinical trial application fees are at par with the USFDA or the European EMIA regulations. So, what is happening is, it’s screening out all the non-compliant players who are trying to come in with low cost and trying to jeopardize the market," Vyas said.
“The definition of having an ethics committee within the 50 km radius of an investigator site has become very strong. So, I believe there is a conducive ecosystem, the growth in the infrastructure in tier 1 and 2 cities with the hospital and the investigator site network, the new regulators have all helped," he further said.
India has an overall clinical trial participation of 3%, but contributes upwards of 15% to the global burden of most high-prevalence diseases such as respiratory infections, cardiovascular, diabetes and cervical cancer, PwC said in a report titled ‘Clinical Trial opportunities in India’ early this month.
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