Drug Discovery and Development at CSIR-Central Drug Research Institute, includes research and development at various phases, as mandated by national and international regulatory guidelines. The Division of Toxicology and Experimental Medicine plays a key role in the process via following various trajectories as outlined below:
- Regulatory studies on pre-clinical safety assessment of new chemical entities as per the guidelines of Drugs Controller General of India (DCGI) and Good Laboratory Practices (Certification granted by National GLP Compliance Monitoring Authority, Department of Science and Technology, Govt. of India)
- Clinical Trials for investigational new drug product development, from Phase I through Phase IV.
- Applied Basic Research within various areas of toxicology towards better understanding of drug toxicity and establishing newer models and methods for toxicity evaluation.

The division is one amongst the only two such facilities from CSIR institutes, to have GLP certification for conducting Acute toxicity studies, Repeat Dose Toxicity studies and Genotoxicity studies for pharmaceuticals. The faculty of the division includes experts from the fields of Histopathology, Haematology, Genotoxicity, Reproductive toxicity, Immunotoxicity, Carcinogenicity and Neurotoxicity. The division is equipped with state-of-the art infrastructure towards carrying out regulatory as well as fundamental basic research studies.

Division is involved in Planning, conduct, and reporting of Systemic Toxicity Studies and Genotoxicity studies (Ames assay) of New Drug Entities per International guidelines (OECD guidelines, 2002, New Clinical trial Rules 2019 India, DCGI) as per GLP norms. Single Dose Toxicity, Dose range Finding Study and Repeat Dose Toxicity Studies in small laboratory animals (rat and mice) and large animals (Rhesus monkeys) are being done with complete clinical examination, hematology, clinical biochemistry and Histopathological examinations of organs and tissues. These studies form an important part of Dossiers which are submitted to DCGI, for permission for Phase I Clinical trials.

India has full adherence member status of OECD’s working group on GLP. Hence the safety Pharmacology and Toxicity GLP studies conducted for variety of pharmaceutical molecules /NCE’s formulations, data is accepted by all l OECD member countries and associated non-member countries.

The division in also involved in conduct of Clinical Trials for investigational new drug product development, from Phase I through Phase IV. The Clinical Trials /studies are planned and conducted developed in accordance with ICH-GCP regulations and ethical requirements, and involve Regulatory Submissions, Medical Writing, Clinical Trial Management, Clinical Trial Monitoring, Data Management, Quality Assurance.

The division is responsible for designing, approval and completion of clinical trials of new drugs. The division deals with preparation of dossiers for investigational new drug (IND) applications including clinical trial protocol, investigator brochure, case record forms, and informed consent documents. It is also responsible for the filing applications, interaction with regulatory agencies, solving their queries and obtaining clinical trial permissions. The division has NABL-Quality council of India accredited facility for hematology and biochemistry testing and ethics committee at CDRI Jankipuram Extension, Lucknow campus.

The institute has set up of Phase 1 clinical trial at King George Medical University, Lucknow, Seth G.S. Medical College and KEM Hospital Mumbai & PGIMER Chandigarh. The phase 2, 3 & post marketing studies are conducted at various hospitals in country based on the site selection and site feasibility assessments.