NIH cancels 40 clinical trials in India
Six months after an apex court slammed Indian pharma MNC’s and researchers for failing to regulate the country’s drug trials environment, the National Institute of Health (NIH) has canceled 40 ongoing clinical trials in India. Despite the Health Ministry’s attempts to improve laws and procedures surrounding the trials, NIH (a branch of the US Department of Health and Human Services) called the regulatory environment still too unstable to continue.
Last January, India’s Supreme Court ordered that all clinical drug trials be performed under the Centre Health Secretary, after the apex court blamed the Health Ministry for neglecting to regulate illegal trials that caused the deaths of thousands of trial subjects. In turn, a growing number of trial sponsors have been driven out of the country to other parts of the world, including Malaysia and Canada.
Following the Supreme Court’s ruling last winter, the Drugs Controller General of India agreed to register a system of ethics committees to monitor the trials,. But medical experts say the process took several months to implement, causing a delay in turnaround time, confusion about regulations, and impeded research efforts. According to a report from Tata Memorial Hospital, one of India’s leading medical center’s, the country’s $500 million clinical trials industry currently functions at only one-fifth of its capacity. Since India’s disease rate ranks among the highest in the world, many civilians depend on new and developing therapies for treatment options. The unstable regulatory environment, say experts, leaves thousands of patients facing serious health risks and adverse effects.
The NIH said it hopes to hear clarification from the Indian government on the issue, and would consider allowing the trials to resume once regulation improvements have been implemented. Some of the possible changes could include providing free and unlimited medical care to injured trial participants, and holding trial sponsors liable for damages for anyone who dies or is injured as a result of “the failure of investigational product to provide intended therapeutic effect” or the use of a placebo.
WGA will continue to monitor this status of India’s clinical trial environment in the coming months. Please contact WGA’s Life Sciences Practice with any questions.
About the Author
Doug Bixby is a Senior Vice President at William Gallagher Associates and heads up the firm’s New York office. He specializes in a variety of areas including technology, life sciences, financial institutions, energy, media, mergers & acquisitions, private equity and venture capital.