In order to support clinical research in medium and small pharma units in India, Department of Biotechnology (DBT) has formed a collegium of teaching universities from across the country which will help, advise and train pharma companies in conducting clinical trials and research for the sake of patient safety.
The collegium comprising experts from teaching institutions like King Edward Memorial (KEM) Hospital, Mumbai, JSS University, Mysore, Christian Medical College (CMC), Vellore and All India Institute of Medical Sciences (AIIMS), New Delhi is likely to meet on November 1, 2013 to discuss and plan out a strategy to develop new procedures and protocols for conducting clinical trials.
Dr B Suresh, vice chancellor, JSS University, Mysore, who is a member of the collegium, said, "This initiative of DBT will help meet the challenge of small companies who cannot approach big Clinical Research Organisations (CRO) or competent institutions due to financial constraints."
The collegium has finally seen the light of the day as more than 50 teaching institutions applied to be a part of the project. After a series of interviews, discussions and inspections, these teaching based institutions which are a part of the collegium were shortlisted based on their eligibility and ability to deliver research, training and conduct clinical trials.
This would be instrumental in helping the small companies get extensive and exhaustive support for developing new procedures and protocols for clinical trials at a low cost.
The current trend of industry driven drug discovery and development rather than science based drug discovery suffers on account of data reproducibility and fails to offer complete data to the scientific community, industry and regulatory authorities.
Indian Pharmacopoeia Commission is in consultation with US Pharmacopoeial Convention, World Health Organisation (WHO) and European Directorate for the Quality of Medicines & HealthCare (EDQM) to come out with strategies to address the challenge of coming out with complete data for setting uniform regulatory standards. Experts conclude that the processes to come out with biological products and vaccines most often vary with each manufacturing company and has a bearing on setting of regulatory standards or guidelines by the government.