The Drug Control General of India (DCGI) and the Indian Centre for Molecular Research (ICMR) has cleared the first Phase 1 trial project to be conducted by an Indian Contract Research Organisation (CRO), the Ahmedabad-based Lambda Therapeutic Research.

Currently the biggest contract research organization (CRO) in India, Lambda has recently been contracted by an Indian pharma major to conduct Phase 1 trial of a new molecule in
the country.

According to Ashish Kumar Dasgupta of Lambda, there will be two trials of oral and intravenous dosage forms and are scheduled to commence around the third week of May. It is the first time an Indian CRO is engaged in conducting Phase I studies. The protocol has been approved by the DCGI and ICMR last week, he said.

It has 100 beds facilities at Mumbai and Ahmedabad for the conduct of Bioequivalence studies. Lambda is conducting almost six to eight pivotal studies a month for submission in Europe and US.