By Stewart Eisenhart, Emergo Group
Indian regulators are adding staff and resources to the Central Drugs Standard Control Organization (CDSCO) in order to enforce more stringent clinical trial guidelines for medical devices and pharmaceuticals.
According to Outsourcing-Pharma.com, the Indian Ministry of Health and Family Welfare has sought stricter oversight of clinical trials following claims of poor safety controls and violations. More than 1,700 patients have died in clinical trials over the past three years, the website reports, noting that “few” of these deaths were directly related to clinical research.
Six investigations have been conducted into alleged violations of Indian clinical trial regulations since 2008. Actions taken by regulators in response to these incidents have included issuing warning letters, temporary trial suspensions and bans, and suspension of research licenses. Such incidents have involved both domestic and foreign clinical research organizations, physicians and one non-governmental organization.
Outsourcing-Pharma.com quotes Indian Minister of Health and Family Shri Ghulam Nabi Azad as saying the CDSCO’s staff and infrastructure are both being expanded in order to more effectively comply with provisions of the country’s new clinical trial rules.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
