India Steps Up Clinical Trial Oversight After Infant Death

Wyeth Pharmaceutical’s recent troubles in India have drawn new attention to the country’s problems enforcing clinical trial standards. In November 2008, an infant died during clinical trials for a Wyeth-manufactured pneumococcal vaccine. This prompted the Drugs Controller General of India (DCGI), India’s chief drug regulator, to suspend the clinical trial and conduct an audit.

Recently, the audit revealed that the clinical trial did not comply with government-mandated regulations, such as standard operating procedure (SOP) and Good Clinical Practice (GCP). Necessary documentation, such as medical files, accountability forms, and consent forms, were often incomplete. The DCGI has requested explanations for these findings. Wyeth responded with confidence that all issues raised would be adequately addressed.

These proceedings have reinforced India’s plans to step up oversight of clinical trials and introduce harsher penalties for companies that violate GCP. The government hopes to improve India’s reputation in safety and quality of clinical trials.

While the trial was monitored by GVK Biosciences, a Contract Research Organization (CRO), and run by the St. John’s Hospital in Bangalore, Wyeth, the drug manufacturer and trial sponsor, will likely be ultimately responsible for compliance with regulations. International companies should ensure that their clinical trials in India comply with Indian SOP and GCP guidelines to avoid penalization.