Indian Regulatory Update: Jan-May 2014

This document provides updates in regulatory requirements regarding conduct of clinical trials in India.

CENTRAL DRUGS STANDARD CONTROL ORGANIZATION RELEASED GUIDANCE FOR AUDIO-VISUAL RECORDING OF INFORMED CONSENT PROCESS

• Central drugs standard control organization (CDSCO) has issued a guidance document for audio-visual recording of informed consent process

• Guidance document has details about procedure, quality, storage and archival

• Details of the order can be read at the following URL: http://www.cdsco.nic.in/writereaddata/Guidance_for_AV%20Recording_09.January.14.pdf.

FORMULA TO DETERMINE THE QUANTUM OF COMPENSATION FOR SERIOUS ADVERSE EVENTS OTHER THAN DEATH

• The CDSCO has issued formula to determine the quantum of compensation in the cases of clinical trial related serious adverse events (SAEs) other than deaths occurring during clinical trials

• The document has been released in the public domain inviting comments from all the stake holders

• The details about the formula can be accessed at the following URL: http://www.cdsco.nic.in/writereaddata/uploaded_for_website__1_FINAL2014.pdf.

REVISED CHECKLIST FOR SERIOUS ADVERSE EVENTS SUBMISSION

• Central drugs standard control organization has issued revised checklist for submission of SAEs

• It gives many new requirements like submission of signed informed consent form, IB, protocol along with every submission of death case

• It now requires unblinded data to be submitted for every death case

• Complete checklist is available at the following URL: http://cdsco.nic.in/writereaddata/procedure%20for%20prescreening%20and%20checklist%20_final%20on%2022-04-2014.pdf.

AMENDED DRAFT FOR 122DAB AND OTHER PROVISIONS OF GSR53E

• Central drugs standard control organization has issued amended draft of 122DAB rule and other provisions made effective as per GSR53E on January 30, 2013

• Further clarity has been provided in the draft notification for considering the SAE related to clinical trial

• Serious adverse events reporting timelines for the sponsor to CDSCO proposed to be changed from 10 days to 14 days

• Provisions proposed for scope of explanation to be provided to the satisfaction of the licensing authority in case investigator fails to meet reporting timelines for SAE starting from the occurrence of the event

• Requirement of submission of SAE reports to Expert Committee (EC) by the Investigator, EC and Sponsor is proposed to be removed

• The draft rules have been published for information of all persons likely to be affected by these rules inviting comments from such persons within 45 days of publication of rules

• Draft can be accessed from the following URL: http://www.cdsco.nic.in/writereaddata/1Draft%20Rules%20on%20compensation.pdf.

Expected procedural changes

Protocol amendment

• In protocol amendment applications, CDSCO now requires maximum participating countries approval letters instead of only key countries

• Ethics committee approvals letters and Principal Investigator no objection letter for proposed amendment will also be necessary

• All changes should be categorized into critical, moderate and mild categories and major changes should be highlighted in the covering letter.

Investigator undertaking as per serious adverse events timelines provided in 122DAB

• At the time of issuing GSR53E in January 2013, investigator undertaking was not modified resulting in continuation of discrepancy in SAE reporting timelines, where undertaking specify a timeline of 7 days from occurrence and regulation mention 24 h from occurrence

• Now Indiana University's need to be in compliance with 24 h timelines for SAE reporting.

Format for technical and Apex Committee evaluation of clinical trials

• It has been suggested by the Supreme Court that the format being used to obtain information for technical committee and Apex committee evaluation of clinical trials should be modified to include specific columns regarding three parameters, namely, (1) assessment of risk versus benefit to the patients, (2) innovation vis-a-vis existing therapeutic option and (3) unmet medical need in the country.