India Looks to Further Ease Process of Running Clinical Trials

Posted 02 August 2016 | By Zachary Brennan 

India Looks to Further Ease Process of Running Clinical Trials

India’s Central Drugs Standard Control Organization (CDSCO) on Tuesday looked to relax two clinical trial requirements that could make it easier to run trials there.

In two joint circulars – from CDSCO, the Directorate General of Health Services, the Ministry of Health and Family Welfare and signed by G.N. Singh, Drugs Controller General –  India will no longer stop trial investigators from conducting more than three trials at a time, and India will revise its requirement that trials must be conducted at sites with more than 50 hospital beds.

The circular on trial investigators reads (grammar and punctuation unchanged from what is in the circular): “As regards restriction that no investigator shall conduct more than three trials at any given period of time, it has been decided to remove the restriction & it is further decided that Ethics Committee after examining the risk and complexity involved in the trial being conducted/proposed shall decide about how many trials an investigator can undertake.”

The new recommendation was decided after two meetings from August and October 2015 as part of deliberations on stakeholder concerns and ways to improve the conduct of clinical trials in India.

The other circular on the beds requirement is less clear but also came as a result of the two meetings from 2015.

It reads (grammar and punctuation adhere to circular’s style): “As regards condition that no clinical trial shall be conducted at site having less than 50 bedded hospital, it has been decided to revise this condition & it is further decided that Ethics Committee shall examine & decide whether the clinical trial site is suitable for trial or not irrespective of number of bed. However, it was also suggested that site shall have emergency rescue and care arrangements along with all other necessary facilities required for that particular trial.”

The changes come as in November 2015, CDSCO unveiled four new updates seeking to promote trial research. India also created a new online trial submission system in September 2015.


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