DCGI's approval stamp on Saurashtra University's clinical studies

Saurashtra University finally gets approval from Drug Control General of India, New Delhi, for clinical studies to department of Pharmaceutical science.

The officials of SU says "Department of Pharmaceutical sciences, Saurashtra University, Rajkot, the only PG pharmacy education in entire region, took initiative to register its ethics committee to DCGI and got approval from the same."

"According to the current law, any ethics committee not registered to DCGI cannot approve or review any clinical trails or bioavailability/ bioequivalence studies in the country" says Dr. Arti Trivedi, the chairman of Ethics Committee, Department of Pharmaceutical Sciences.

"Due to stringent guidelines and regulations, currently very few ECS are able to register with DCGI," says Dr. Naveen Seth, Dean, Faculty of Pharmacy and head, Department of Pharmaceutical Sciences, SU.

He further added "In India as many as 2,644 people died during the clinical trails of 475 new drugs on human beings in last seven years and only 17 of medicines were approved for marketing in India. In this regard, Indian government established a three tier security system comprising New Drugs Advisory Committee, technical committee and apex committee to examine applications for clinical trials in India in the early October this year. The law governing classical trail witnessed sea change in past 6-8 months and ethics committee (Ecs), the group of people that projects rights and look after well being of participants of clinical trials, have been forced to register to Drug Controller General of India (DCGI), New Delhi before granting approval of any clinical trials proposals."

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