Safety, Dosage Form Design, Pre-Clinical and Clinical Development of candidate drugs are the primary concerns of the Divisions of

Regulatory ToxicologyRegulatory Pharmacology
Clinical & Experimental Medicine 

Together, these divisions represent the β€œCRO” (committed research organization)-- available to drug discovery scientists at CDRI and collaborating research organization for other academic or industry partners in drug development. Task forces formed by designated personnel from these Divisions are entrusted with the development of new chemical entities / new drug entities. Investigational New Drug (IND) applications are prepared as per guidelines of Schedule Y of the Indian Drugs & Cosmetics Act, (Amended 2005). The group is involved in generation of a large amount of data in relation to methods of manufacture and resultant analytical specifications, storage stability, formulation and delivery systems, pharmacokinetics, pharmacological mechanisms of action, efficacy and safety in animal models including rodents and non-human primates and the elucidation of mechanisms responsible for different pharmacological and toxicological effects. Based on such data, necessary documents and protocols are prepared for seeking regulatory permission and conduction of clinical trials. The following activities are carried out in cohesion by the constituent Divisions:

Team Members
Coordinated by Translational Research Team
image01 Dr. Madhu Dikshit, Chairman
image01 Dr. Ashim Ghatak
image01 Dr. AK Dwivedi
image01 Dr. Sudhir Sinha
image01 Dr. J Lal
image01 Dr. SK Rath
image01 Dr. Amit Misra, Head, Medicinal & Process Chemistry
image01 Dr. Sripathi Rao Kulkarni
image01 Mr. Naseem Siddiqui

Pharmaceutics Safety PharmacologyToxicology
Dr.AK Dwivedi Dr M Dikshit Dr S. Sharma
Dr. Amit Misra Dr R Shukla Dr SK Rath
Dr.PR Mishra Dr M Bharatwal Dr RK Tripathi
Dr.MK Chourasia   Dr A Nazir
Pharmacokinetics Clinical & Experimental Medicine Dr RK Singh
Dr. J Lal Dr.A Ghatak Dr Smrati Bhadauria
Dr Wahajuddin Dr.Vivek Bhosale Dr Sarika Singh
Dr RS Bhatta   Dr Poonam Singh