Parexel completes CRO registration with CDSCO under new G.S.R 581(E) regulation
Parexel aligns with CDSCO regulatory framework, ensuring continued clinical trial operations in India
Parexel, a global clinical research organisation (CRO) offering Phase I to IV clinical development services, has announced the successful completion of its registration with the Central Drugs Standard Control Organisation (CDSCO). This move is in compliance with the Government of India’s G.S.R 581(E) regulation, which mandates CROs operating in India to register with CDSCO.
The regulation aims to formalise and monitor clinical research activities across the country, ensuring that CROs meet consistent regulatory standards. Parexel’s registration under the new framework allows it to continue supporting clinical trials in India across a range of therapeutic areas.
Sanjay Vyas, President and Managing Director of Parexel India and Global Strategic Business Unit Head for Clinical Logistics & Global Safety Services, stated,“This registration reflects our ongoing commitment to meeting regulatory requirements and upholding the highest standards in clinical research. This registration enables us to continue supporting our customers in bringing life-saving treatments to patients safely and efficiently.”
Parexel has operated in India for over two decades and employs more than 6,000 professionals in the country. The company continues to deliver clinical trial services in collaboration with its global network and clients. It also acknowledges the contribution of its India-based workforce in securing this regulatory milestone.
The CDSCO registration reaffirms Parexel’s operational readiness under evolving regulatory conditions and supports its role in the clinical development of medicines across therapeutic categories.