India has 16% of the world’s population and accounts for 20% of the world’s disease burden, yet less than 1.4% of global clinical trials are conducted there. A series of blemishes in clinical research has shaken worldwide confidence—but experts say positive steps have been taken to bring hope for the future.
The latest setback came in April from the World Health Organization (WHO), which sent a notice of concern to the Indian CRO Semler Research, alleging data manipulation in a number of bioanalytical studies uncovered during site visits in December and January. WHO said its findings question the validity of studies performed for 12 products and that companies including Mylan, Lupin, Micro Labs and others may need to repeat trials conducted by the CRO.
“Clinical research in our country is an important health imperative and necessary for the advancement of the health of our people and the economy,” said Suneela Thatte, president of the Indian Society for Clinical Research (ISCR), which aims to build awareness of clinical research as a specialty in India and to facilitate its growth while ensuring quality and ethics.
“While we do not condone any irregularities, we would also like to acknowledge there are several hundreds of clinical trials taking place in the country in compliance with international and local guidelines,” Thatte continued. “Given India’s increasing burden of disease, there is an urgent need to build confidence and trust among global stakeholders conducting clinical research in India and to foster an environment and ecosystem that encourages it.”
“I think India in general is a very attractive market,” said Mohit Mehrotra, chief operating officer of Excel Life Sciences (ELS), a U.S.-based, India-focused provider of clinical trial management services. “The challenge to managing drug development is making sure that the infrastructure is put into place to do the research in a way that is credible and is not compromised on ethics or integrity.”
Unfortunately, uncovering violations in any one area of the business seems to shake confidence in the whole arena, including clinical research, Mehrotra said. “Up until now, most of India’s focus and problems have been on the manufacturing end. One has to separate the pharma industry from the clinical research. Very often, everything gets lumped into one, and India’s reputation has suffered.”
A 2015 survey by Ernst & Young concluded that the Indian pharmaceutical industry was struggling with data integrity issues, highlighting problems related to lax documentation, lack of data reviews and severe pressure to demonstrate key performance indicators of products.
Contributing to India’s difficulties has been slow government commitment to the industry. In a recent report by Information Technology & Innovation Foundation that ranked 56 nations on the extent to which their scientific research, drug pricing and intellectual property policies contribute to global biopharma innovation, India came in last.
India did not enter the global clinical trial market until the 1990s, and the pendulum in India has swung wildly over the past decade. In 2005, regulations were amended to liberalize how drug trials were conducted, and companies flocked there because of the large and genetically diverse population.
In light of serious issues surrounding subject death and lack of informed consent, India’s Supreme Court ruled in 2013 that no clinical trials would be allowed for new drugs until a reliable system was put in place to monitor them. As a result, the number of new clinical trials dropped dramatically, falling from 480 applications (253 approved) in 2012 to 207 (73 approved) in 2013.
Despite the setbacks, slow progress is being made to put India back on track, experts say. “The last three years were a challenging period for clinical research in India,” Thatte said. “Late 2014 and through 2015 saw steps taken by regulators to mitigate these challenges and address stakeholder concerns through amendments in regulations, new orders and further guidance on existing ones. We now have a regulatory system that is balanced, aligned with global trends and one that addresses our uniqueness as a country and society.”
Another step forward came last autumn. As part of an effort to increase transparency, accountability and efficiency in processing clinical trials applications, India’s Central Drugs Standards Control Organization (CDSCO) launched a new online submission system for trials. The goal of the online system was to help protect the rights and safety of trial subjects, as well as the authenticity of the data generated.
Global partners are reaching out in support as well. In September 2015, the WHO collaborated with the Clinical Trials Registry—India (CTRI) and the Indian Council of Medical Research (ICMR) to launch e-learning modules for the registration of clinical trials, aimed at educating institutions undertaking clinical research and sharing best practices.
At Quintiles, a major provider of biopharmaceutical development and commercial outsourcing services, 6,500 of its 36,000 employees globally are based in India. Tom Pike, Quintiles’ chief executive officer, discussed in an April interview with The Times of India how regulatory changes related to clinical trials will help bring more drug research to India.
“In our industry, it takes a while to rebuild,” Pike said. “One exciting development is that approvals for clinical trials are now taking about six to seven months, which is the global standard. It used to be 15 months in India a couple of years back.”
Revised clinical trials guidelines in 2015 have improved the research environment and is returning India to the global map, Pike said. “There is great interest in treating this population with upcoming medicines and vaccines, especially given the large burden of disease here.”
“What has been encouraging is the inclusive approach adopted by the Indian regulators whereby stakeholder feedback has been actively sought and acted upon in many cases,” said Thatte. “The compensation guidelines are now more balanced and rational, we are beginning to see more predictable approval timelines with the expansion of the Subject Expert Committees and the expected roll-out of the accreditation process is projected to have a significant impact on the quality of research.”
Mehrotra believes clinical research in India is reviving in the right ways. “What’s most important is that companies in foreign markets are realizing that India does present a tremendous market for research because you have the population,” he said. “Stakeholders are continuing efforts to improve processes and ensure that the clinical development work in India continues to meet global standards.”
This article was reprinted from Volume 20, Issue 17, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »