The Central Drug Research Institute had established the Clinical Pharmacology Unit (CPU) in 1971 to undertake Phase I clinical studies on new drugs under development at the Institute and to coordinate Phase II and III trials.

In 1985, considering the impressive outcome of the clinical trials and increasing quantum of work till then the CPU was elevated to the status of a full division and it was designated as Division of Clinical & Experimental Medicine.

The Division is mainly responsible for conduction and coordination of clinical trials (Phase I, II and III) and pharmacokinetics studies on drugs developed at CDRI or those products which are sponsored under contract research activity. The candidate drugs taken up for trials include both synthetic or isolated from natural sources.

The Division is staffed with medically qualified and experienced investigators supported by skilled technical staff. An extension unit of 10 beds at K.G.'s Medical College, Lucknow and a similar unit at Seth G.S. Medical College, Mumbai share part of the responsibilities in conducting clinical trials.

All the laboratory investigations (routine, haematological, biochemical, ECG and ultrasonography, etc.) are carried out in the division using modern and sophisticated instruments.

Reliability of investigations, precision in techniques and accuracy in methodology are under continuous check through an external quality control programme with the help of the WHO centre based at Middlesex, UK. Results from Clinical & Experimental Medicine Division are consistently comparable to the results obtained from developed and scientifically advanced countries.

There exist facility for indepth statistical analysis of data using experienced staff in biometrics and statistics and computer facilities. Compilation of data and its presentation in the form of dossier for submission to Drugs Controller General (India) is a part of the Division's responsibility.

During the period 1971 to 1999 over two dozen new compounds have successfully completed different phases of clinical trials. During the period nearly 1500 normal healthy volunteers have participated in Phase I tolerability studies and several thousand patients have undergone different phases of clinical trials during clinical studies of different drugs. CDRI also effectively coordinated the trials with clinical pharmacology extension units at Seth G.S. College, Mumbai and K.G.'s. Medical College, Lucknow.