The Nizam's Institute of Medical Sciences (NIMS) is making a significant contribution to the field of clinical research and new drug development. On an average, NIMS conducts about 70 clinical studies (Phase I, II, III, IV) every year of which about 80 per cent of the studies are phase III. Majority of the clinical trials conducted in the country are phase III studies, Dr M U R Naidu, professor and head, Department of Clinical Pharmacology and Therapeutics and dean, NIMS told Pharmabiz.

NIMS is one of the few institutions in the country that conducts phase I trials. In addition, NIMS' Institutional Ethics Committee reviews about 250 research proposals every year, complying to national and international guidelines. The Institute has set up clinical research facilities on par with international standards. It conducts studies for both Indian pharma and biotech companies and MNCs.

Of the clinical studies carried at NIMS, most common therapeutic categories for which drugs are tested are Oncology, Neurology, Infectious diseases and Rheumatology. Biotech companies are also collaborating with NIMS for conducting studies on vaccines, constituting 10 per cent of all the studies conducted. It has in the recent past conducted studies on a meningococcal vaccine as part of a WHO initiative, which is likely to be launched soon in South Africa, he informed.

The Centre for Cellular and Molecular Biology (CCMB) and the NIMS are jointly planning to establish a Clinical Research facility to develop stem cell technologies and regenerative medicine, at Hyderabad. An investment of Rs 11 crore will be made in establishing this facility. The facility is expected to be operational by the end of 2007. The facility will include laboratory for basic research and development, laboratory for clinical research and other infrastructure facilities.

Meanwhile, the Department of Chemicals and Fertilizers, is keen to develop a NIPER like institution in Hyderabad and has identified IDPL as a suitable location for such centre. Government of Andhra Pradesh too has recognised the scope for utilising IDPL facilities and premises for pharmaceutical research and training.

IDPL has in-principle agreed to allow NIMS to run its courses at IDPL premises. NIMS existing facilities in its own premises can also be used for some of the activities as part of the initiative and the Department of Clinical Pharmacology and Therapeutics can help in developing necessary infrastructure at IDPL and improve existing capabilities at IDPL, Dr Naidu added.

The Hyderabad centre would strive to go beyond pre-clinical research and carry out clinical research besides training. NIMS are planning to establish a training centre for clinical research integrated to the proposed NIPER like institution. Diagnostic and testing facilities may be established in IDPL. Hospital that will involve in clinical research and other clinical research facilities will remain in NIMS.

NIMS has been involved in clinical development, teaching and training programmes and has been offering unique super specialty courses such as DM Clinical Pharmacology. The Institute has been making efforts to increase and improve trained manpower availability in the fields of clinical pharmacology and therapeutics. It has acquired about 125 acres at Bibinagar in Hyderabad to establish a full-fledged University campus, it is learnt.

India has become a key centre to contribute for clinical trials and Hyderabad in particular is attracting a significant portion of clinical research activity happening in the country as basic infrastructure and capabilities required for clinical research and drug development is well established.

The presence of good quality hospitals, logistics, laboratories, IT, pharma and biotech companies, skilled scientists, medical professionals all make Hyderabad a destination for clinical research development, Dr Naidu added.