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Regulatory Update on India Clinical Research Approval Timelines

RESEARCH TRIANGLE PARK, N.C., Feb. 3, 2014 /PRNewswire/ -- Dr. Renu Razdan, Vice President ACRO India and also the Chief Operating Officer, Max Neeman Medical International welcomes the new timelines and guidelines set up by the Drug Controller General of India [DCGI] for approval of clinical trials.

The Drug regulatory authority in India has provided written confirmation to the pharmaceutical industry and Investigators that, clinical trial approval will be given within 180 days of submission of clinical trial application provided all the submitted documents are complete. Also clinical trial protocol amendments will be approved within 60 days, if consultation of NDAC is not required. The notification was issued on 24th January 2014.

In another step to further make clinical trials transparent and safe, the Drug Controller General of India [DCGI] made it compulsory in November 2013, to not just obtain written informed consent from subjects participating in drug trials but also present audio visual recording of informed consent process of each new trial subject.

Clarity has also been brought on the much debated issue of medical management and financial compensation paid to patients during clinical trials. Recent guidelines state that a trial subject needs to be medically managed only when the injury to the subject is deemed trial related and compensation need not be paid for injury or death due to unrelated causes. 

India has been a preferred destination for conducting clinical trials to test the safety and efficacy of various drugs before they are approved for launching in the market. The country is gearing up to attract more researchers from around the world to conduct their clinical trial studies in India. Laws are being amended to facilitate the entry of global clinical trials. Reasonable and reliable approval intervals combined with other attractive clinical trial attributes and recent improvements make India an important solution in the quest for high quality clinical data. 

About Max Neeman International
Max Neeman International is one of the leading and largest CROs in India. Our specialty is that we offer services for the successful conduct of Phase II-IV clinical and device trials for small and mid-sized international and national Pharmaceutical, Biotechnology, Medical Device and Nutraceutical companies in compliance with ICH GCP standards. Operational since 2001, Max Neeman is an ISO 9001:2008 & ISO 27001:2005 certified CRO for Monitoring, Site Management and Data Management Services. Please contact Vice President USA, Donald Swankie at 919.424.3345 / [email protected].

SOURCE Max Neeman International

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