India Issues Draft Rules for Clinical Research Organizations
India's drug regulator, the Central Drug Standard Control Organization (CDSCO), issued draft rules mandating the registration of clinical research organizations that conduct human studies on drugs, cosmetics and medical devices.
The guidelines, known as Schedule Y-1, require organizations to adhere to standard operating procedures to obtain a license of registration, which is valid for five years as long as the CRO adheres to stated requirements.
CDSCO is currently seeking comment on the proposed changes.
Earlier this summer, the organization implemented a new rule mandating that all clinical studies conducted in India be registered in a clinical trial registry maintained by the Indian Council of Medical Research.