Department of Pharmaceutical Sciences of Saurashtra University (SU) has received approval of clinical studies from Drug Controller General of India (DCGI) in New Delhi.
As informed by SU officials, Department of Pharmaceutical Sciences, Saurashtra University in Rajkot is the only PG pharmacy education in entire regionand has taken initiative to register its ethics committee with DCGI and obtain consent for the same.
As per the ongoing law, DCGI cannot approve or review of any clinical trials or bioavailability/bioequivalence education in the country, until its ethics committee is not registered with them, told Dr. AartiTrivedi, Chairman of Ethics Committee, Department of Pharmaceutical Sciences.
Due to strictnorms and regulations, at presentactually few Ethics Committees are able to get registered with DCGI told Dr. NavinSheth, Dean, Faculty of Pharmacy and head, Department of Pharmaceutical Sciences, SU.
Dr. Sheth further told about 2,644 deaths occurred during the clinical trials of the new 475 drugs on humans in thepast 7 years in India. Of all the drug trials mere 17 medicines were accepted for selling in the country.
Seeing this, in October 2013 the GOIset up a three-tier scrutiny system involving New Drugs Advisory Committee, technical committee and apex committee to inspect applications for clinical trials in India. The ethics Committees, participants of clinical trials have bow pressure to get themselves firstregistered withDrug Controller General of India (DCGI) in New Delhi and obtain approval.