Several days after using some flowery language to wave off a question from FierceBiotech regarding the fate of dozens of NIH-sponsored trials in India, the government agency has found its speaking voice.
In response to a follow-up query from us after picking up word that BioCentury finally managed to get a fairly direct response, we heard this from a spokesperson at the NIH:
"The recent clinical trial regulations in India have affected some NIH studies. Some trials have stopped enrollment and some others have been postponed. NIH has expressed its concerns about the new regulations, and looks forward to hearing clarifications from the Indian government on this important issue. The NIH hopes that future changes will enable studies to resume, and that we will be able to continue collaborations with colleagues in India for the mutual benefit of our citizens."
There were even several links to the controversial new regulations being vetted in India, including this one that requires that anyone injured in a clinical trial will be "given free medical management as long as required." All trial sponsors will be liable for damages for injury or death. And the liability extends to anyone who dies or is injured due to the "failure of investigational product to provide intended therapeutic effect" or the use of a placebo.
Trial sponsors don't really know what these provisions mean. Are they on the hook for lifelong medical care and big damages? Even if it's because the drug didn't work as hoped?
As a result, the NIH has joined the exodus of trial sponsors out of India, clearly indicating that they want the country to take a hard look at what they're doing with the law.
For India, the NIH decision to slam the brakes on its work in the subcontinent presents the government with a clear choice: Continue with its own notions of protective regulations or try to salvage what it can before the global drug industry completely shuns the subcontinent.