Pharma Positive news: DCGI approves Saurashtra University for clinical studies "D"

RAJKOT: Drug Controller General of India (DCGI), New Delhi, has given approval for clinical studies to department of Pharmaceutical Sciences of Saurashtra University (SU).

According to SU officials, 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 trials or bioavailability/bioequivalence studies in the country" said Dr. Aarti Trivedi, who is 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'' said Dr. Navin Sheth, Dean, Faculty of Pharmacy and head, Department of Pharmaceutical Sciences, SU.

Dr. Sheth said that India as many as 2,644 people died during the clinical trials of 475 new drugs on human beings in last seven years and only 17 of the medicines were approved for marketing in India. In this regard, Indian government established a three-tier scrutiny 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 clinical trials witnessed sea change in past 6-8 months and ethics committees (ECs), the group of people that protects 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''.