Parexel Secures CDSCO Approval Under G.S.R 581(E) Guidelines

• Parexel is officially registered with India's CDSCO under G.S.R 581(E)

• Supports Parexel’s ability to conduct Phase I-IV clinical trials in India

• Strengthens Parexel’s role in advancing global drug development in India

Parexel, a top-ranked international clinical research organisation (CRO), has formally registered with India's Central Drugs Standard Control Organisation (CDSCO), in line with the newly imposed G.S.R 581(E) regulation. This regulation, gazetted by the Government of India, mandates all CROs that are involved in conducting clinical research in India to register with CDSCO to provide regulatory oversight and ensure uniform practices.

?This milestone confirms Parexel's capabilities in running clinical trials within India and demonstrates its commitment to operating in a more formalized and open regulatory landscape. The company has been a champion of clinical development from Phase I through IV and will remain so across diverse therapeutic areas.

Commenting on the achievement, Sanjay Vyas, President and Managing Director of Parexel India and Global Strategic Business Unit Head for Clinical Logistics & Global Safety Services, said, "Securing CDSCO registration underscores our dedication to compliance and excellence in clinical research. It enables us to confidently support our customers in advancing life-changing therapies for patients.”

Also Read: OneSource's Flagship Bangalore Plant Remains USFDA Compliance

Parexel’s two-decade presence in India is supported by a robust team of over 6,000 professionals. The organization credits its India-based workforce for its instrumental role in achieving this regulatory milestone and continuing to drive its mission of supporting global drug development with quality and speed.

This registration gives Parexel further consolidation of its operational preparedness under India's changing regulatory environment to continue its contribution toward the safe and efficient development of new drugs.