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.”