The Association of Contract Research Organizations (ACRO) India has backed the decision of the Drugs Technical Advisory Board (DTAB) to make it mandatory for all Ethics Committees attached with Clinical Trial Organizations (CROs) to register themselves with the Drugs Controller General of India (DCGI). The decision by DTAB, the highest decision making body under the Union Health Ministry on technical matters, taken at its meeting held on 10th October will give a much needed shot in the arm to ACRO India’s efforts of promoting best practices in the Clinical Research Space in the country.
Commenting on the development, Apurva Shah, Chairman, ACRO said, “This move is in line with our efforts of building a sound regulatory framework that would assist in setting new benchmarks for clinical practices in India. As an industry, CROs in India have been complying fully with both Indian and international standards and some of them have even won accolades for their compliance. This decision will only help increase transparency in terms of subject recruitment, consent process, independence of the Ethics Committee and its review and decision making process.”
This development comes almost two years after the DCGI first made the registration of clinical trials in India mandatory. It assumes significant proportions in light of the mandate of the Ethics Committee in any CRO that includes ensuring protection of rights, safety and general well being of human subjects involved in clinical research and recent allegations that some Ethics Committees at clinical trial sites were not independent and active with regard to the monitoring of trials. Following this decision, henceforth, the DCGI will not provide a sanction for beginning of clinical studies in the country.
“The recent development is in line with international best practices where prior to starting a trial, researchers need to submit a detailed plan of their proposed research protocol to a recognized research ethics committee,” adds Ashish Dasgupta, Vice Chairman, ACRO. “Such initiatives as regulations are a great welcome not only to the industry but to the nation as well, as this will go a long way in ensuring greater transparency.”