NIH's recent decision to suspend or delay clinical studies in India is a consequence of a clumsy rule change hastily implemented by the country's regulatory authority. Stakeholders in industry and the clinical community in India agree on a solution proposed by an advisory committee to the Drug Controller General of India, but opinions vary as to whether it will be months or years before the government sees fit to address the issue.

In January, India's Ministry of Health and Family Welfare published new rules governing the conduct of clinical trials in an effort to ensure patient safety after a rash of media reports and subsequent litigation related to clinical trial deaths led the country's Supreme Court to intervene by directing the ministry to make reforms.