Revised list of documents to be submitted to DCGI for grant of BA / BE NOC - Updated JAN-2014

DCGI has revised the list of documents that need to be submitted for grant of BA / BE NOC. The new revised requirement if approved will be effective from 01^st February 2014

To ensure uniformity in documents submitted to the Directorate (Drug Control General of India, DCGI) for review and approval of permission to conduct BA / BE studies in human subjects or patients for export purpose, the DCGI has issued a revised draft checklist. The revised draft checklist for DCGI BA / BE NOC will become effective from 01^st February 2014.

The salient features of the revised draft checklist of documents required for issue of BA / BE NOC that will be effective from 01^st February 2014 are,

1. *BA / BE NOC need to be applied to conduct clinical trials with drugs approved and available in India for more than 4 years
2. Undertaking letter from the sponsor stating that the sponsor will provide complete medical care as well as compensation in instances of study related injury or death. This is in addition to the statement to this effect incorporated in the Informed Consent Form
3. The study protocols, Informed Consent Form (ICF) or Patient Information Sheet (PIS) along with audio-visual recording system as per Schedule Y guidelines
4. Report of any study related deaths during last 3 years if any that has occurred in the study centre
5. For all new molecule not approved in India, new drugs approved in India within a period of one year, modified release formulations for which the DCGI has issued BA / BE NOC, all BA / BE centres should furnish an annual status report of the project details, the start and end date of the project, study location, Serious Adverse Events if any encountered, study results and outcome etc to DCGI for its review and record purpose. This exercise should be carried out on or before 15th January of every year to ensure the safety and wellbeing of the participating healthy human subjects and or patients

*Till now DCGI BA / BE NOC is not required, to conduct clinical trials with drugs approved and available in India for more than 4 years. These drugs are deemed as old drugs.

A detailed post on the DCGI BA / BE NOC document requirement will be posted over here once the draft list is finalised. Watch this space or sign up for our newsletter to get updates automatically in your inbox.