Resolve Regulatory Issues for Clinical Trials, DCGI Told

by Kathy Jones on  September 30, 2010 at 9:36 PM Drug News   - G J E 4
The Association of Clinical Research Organizations (ACRO) has warned that the Drug Controller General of India (DCGI) should resolve the uncertainty over the regulatory system of conducting clinical trials in India as soon as possible if they want to avoid a slump in the market of sponsored clinical trials.
 Resolve Regulatory Issues for Clinical Trials, DCGI Told
Resolve Regulatory Issues for Clinical Trials, DCGI Told

Speaking out on the issue, the vice president of public affairs at ACRO, John Lewis said that while the clinical trials market in India has grown rapidly over the past few years, the growth saw a slowdown last year due to the confusion surrounding the regulatory system.

He went on to add that while India is the best place to conduct such trials because of the very high quality of research available, other countries including China are taking big strides towards dominating the clinical trials market.

"We hope phase I trials to be conducted on a regular basis in India as it will help the overall drug development industry in the country, especially for innovative new products. However, there is a necessity for the sponsors and CROs to require a high level of regulatory predictability before they will place phase I trials in India on a large scale", Lewis added.

Source: Medindia

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sponsor's and CRO's should take clear and strict stand on recording of AE's and ADR's as they are with SAE's. The investigators must be pushed to take care of the AE's and ADR's as they do with SAE's. This will make participation in clinical research safer for the participants which is the utmost priority of clinical research trials.
kavitamital209 Tuesday, August 9, 2011

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