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.
He informed Pharmabiz that there are few more Phase I studies under various stages of discussions for the CRO. It may be recalled that Lambda was also the first Indian CRO, which has two clinical research facilities in India. 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. The CRO now awaits USFDA inspection, which is expected to begin soon. Lambda is equipped with 12 HPLCS and 4 LC/MS/MS. Very soon few more LC/MS/MS will be added to enhance the bioanalytical capability. Lambda has also forged into phase II-III trials in various therapeutic segments like Anti-cancer, gastro-intestinal, autoimmune disorders, respiratory diseases etc.