India Announces Regulatory Priorities
Posted 15 April 2013 | By
Clinical trial related issues account for four of the seven regulatory priorities announced by India's Central Drugs Standard Control Organization (CDSCO), the country's drug regulatory authority, on 10 April 2013.
According to the CDSCO notice, the priorities are regulatory issues that require "greater attention … for safeguarding and enhancing the public health."
Among the clinical trial-related priorities mentioned in the notice are the registration of Ethics Committees, clinical trial monitoring, review of serious adverse events, and the protection of human subjects.
The remaining three priorities relate to drug approval, drug experience monitoring, and the examination of safety issues related to drugs marketed in India.