Looking at India anew
By: Naz Haji | May 17, 2016
Clearer regulations, better infrastructure, strong talent and rich pools of patients make India an attractive destination for clinical trials once again.
For the past few years, India has been viewed as a complicated and uncertain place to conduct clinical trials due to an unpredictable regulatory environment. But recent changes, coupled with the many local benefits of doing clinical research in India, make it worthy of taking a second look.
India is home to approximately 17% of the world’s population and 20% of the global disease burden, which comes from a triple burden of communicable diseases, non-communicable diseases and socio-behavioral illnesses. In many cases, India struggles with diseases that have been nearly eradicated in other countries, including tuberculosis, cholera, and the measles, while also dealing with growing rates of cancer, cardiovascular disease and other commonly Western illnesses due to rising income, lifestyle changes and aging populations.
Even with all of this unmet medical need, less than 1.4% of global clinical trials currently take place in India, which means biopharma companies are missing out on an opportunity to recruit from a deep pool of treatment-naive patients who may be eager to participate in trials that would give them access to life saving drugs. They are also missing out on the increasingly sophisticated site infrastructure and young, highly-skilled, mostly English-speaking talent pool available to manage these trials, often at a lower cost than in other countries. It’s also a smart strategic move for sponsors who are interested in selling products to India’s 1.25 billion citizens, whose demand for new treatments is steadily increasing. Recent reports show pharmaceutical sales in India are expected to expand at annual rates of nearly 11 percent through 2019.
Regulatory changes drive innovation
The low rate of clinical trials being conducted in the country was due in large part to the evolving regulatory environment and shifting rules, that created inconsistency and often long delays in gaining approvals, but things have improved in the last two years thanks to new rules and a more collaborative approach by regulatory agents. Indian regulators are committed to creating a more rational and scientific framework for ensuring patient safety and efficacy in clinical trials while still enabling sponsors to drive innovation. The changes, which more closely align with global regulatory frameworks, have dramatically streamline the approval process, which now takes roughly six months (similar to other countries) down from 15 months a few years ago.
As a result, the future for Indian clinical trials looks promising, with more global biopharma companies launching trials in the country than we’ve seen in years. Several innovative solutions have already emerged. In February 2016 Indian firm, Bharat Biotech, filed for global patents on two Zika vaccine candidates to begin pre-clinical trials, making it the first biopharma company to respond to the Zika crisis; and a month later, the Health Ministry of India launched the country’s first, indigenous rotavirus vaccine to combat diarrheal deaths under its Universal Immunisation Programme. Diarrhea caused by Rotavirus is one of the leading causes of severe diarrhea and death among children less than five years of age. The Health Minister J.P. Nadda called it “a new milestone towards expanding the coverage of full immunisation in the country aimed at reducing child mortality”.
Both solutions address real world problems, and underscore the Indian government’s commitment to supporting innovation efforts in the biopharma space. Global biopharma companies looking for a place to run cost-effective trials with access to patients, expertise and site leadership, should be reconsidering India. It is a land of opportunity that can give sponsors a competitive advantage in bringing new treatments to market.