According to the Office Order dated 03-Jul-14 issued by the CDSCO, a Principal Investigator could not conduct more than three (03) clinical trials at any given period of time, irrespective of whether those clinical trials were actively recruiting or were in long term follow-up!

In addition, since the past two (02) years, the Drugs Controller General (India) (DCG(I)) office had been restricting the permissions to conduct clinical trials in India to hospitals with capacity of 50 or more beds, irrespective of whether the clinical trials were for out-patient populations or required in-patient hospitalization.

 

Both of these restrictions have now finally been relaxed by the DCG(I) via two circulars, both dated 02-Aug-16 (links below).

According to these Circulars, the decision on the number of clinical trials per investigator and the suitability of sites will rest with the respective Ethics Committees.

The Ethics Committees, after examining the risks and complexities involved in the proposed clinical trials, shall decide on how many trials an Investigator can undertake and whether the clinical trial site is suitable or not, irrespective of the number of beds at the site. The sites will however be required to have emergency rescue and care arrangements along with all other necessary facilities.

Hopefully this will shift the equilibrium for clinical trials towards normalcy in India! 

Relaxing ‘number of clinical trials conducted’ condition:

http://www.cdsco.nic.in/writereaddata/restricion%20of%20conducting%20three.pdf

Relaxing ‘number of beds’ condition:

http://www.cdsco.nic.in/writereaddata/requirement%20of%2050%20bedded%20.pdf

The ADAMAS Corporate Brochure 2016

 

Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

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Regulatory Environment

 

The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.

adamas-quality-assurance-services

 

ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.

 

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How to be a Clinical Auditor

 

‘So you want to be a Clinical Auditor?’, an article written by CEO Dr. Patricia Fitzgerald.

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Benchmarking Data

 

Please download our benchmarking data sheet, to see how these data compare with your own performance. To discuss a more detailed report, or analysis of a data subset, please get in touch.

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Is your QMS compliant?

 

Is your QMS compliant to the upcoming ICH E6 Addendum? Download our 5-point checklist

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ICH (E6) R2 Addendum - Step 4

 

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