Many of these challenges have now been resolved, but the reality is that sponsors have been much slower to re-enter the Indian market than expected.
If we look at data from clinicaltrials.gov, there were 101 “Industry Funded” trials started in 2012, but only 27 recorded in 2016. Novotech’s key customer group is small to midsized biopharmaceutical companies, and they have fallen from 44% of trial activity in 2012 to 15% in 2016. This shift is understandable as the larger pharmaceutical companies often have experience while smaller biopharmaceutical companies, with a smaller portfolio of compounds will be more risk averse until they are very certain that the environment has improved.
As clinical trial activity, has declined, many CROs have redeployed management, biometrics, pharmacovigilance, risk based monitoring and administrative support, and so the contraction clinical trial activity.
Indeed, Novotech’s Indian workforce has increased by around six-fold since 2012. While setting up any business in Asia has it’s complexities with a range of regulations, and bureaucratic institutions needing to be navigated, we have found India to be a relatively business friendly environment,, with notable improvements over the last three years.
We remain very optimistic about the future of clinical trials in India, and the key macro huge treatment naïve population, with India expected to surpass China as the most populous county in the world in coming decades ii) highly pharmaceutical manufacturing sector ensuring sponsors continue to invest in infrastructure and talent iv) An attractive cost base.
We are currently starting a couple of clinical trials in India for smaller biopharma clients and we are very excited by the progress. Regulatory timelines have been faster than expected, and everyone is very engaged including sites, investigators, ethics committees, and is investing additional resources in overseeing our Indian clinical trials because we are very keen to anticipate and minimise any issues, so that we can promote India as the clinical trial destination it deserves to be.
- Dr John Moller
CEO, Novotech, a Sydney-based full-service contract research organisation (CRO), having operations in India, with a focus on clinical monitoring