Regulatory Updates Kedar Suvarnapathaki Department of Regulatory Affairs, Boehringer Ingelheim India Pvt. Ltd., Bandra (E), Mumbai, Maharashtra, India
Indian Regulatory Update: September‑November 2013
Address for correspondence: Mr. Kedar Suvarnapathaki Boehringer Ingelheim India Pvt. Ltd., 1102, 11th Floor, Hallmark Business Plaza, Bandra (E), Mumbai ‑ 400 051, Maharashtra, India. E‑mail: kedar.suvarnapathaki@ boehringer‑ingelheim.com
This document provides updates in regulatory requirements regarding conduct of clinical trials in India.
CONTRACTS WITH INVESTIGATOR TO BE SUBMITTED TO CENTRAL DRUGS STANDARD CONTROL ORGANIZATION (CDSCO) •
CDSCO has issued an office order to submit copy of clinical trial agreement to be submitted to CDSCO along with every clinical trial application
•
It was subsequently clarified by CDSCO that if such agreement is not available at the time of submitting the application, same can be provided before initiation of study S uch agreement needs to provide details of financial support, fees, honorarium and payments in kind etc. D etails of the order can be read at following URL: http://www.cdsco.nic.in/Furnising%20 of%20information%20in%20respect%20of%20 financial%20 support%202013.pdf.
• •
FORMULA TO DETERMINE THE QUANTUM OF COMPENSATION •
The CDSCO has issued formula to determine the Access this article online Quick Response Code:
•
DOI: 10.4103/2229-3485.124575
T he details about the formula can be accessed at following URL: http://www.cdsco.nic.in/ formula2013SAE.pdf.
ACTIONS ON THE RECOMMENDATIONS OF PROF. RANJIT ROY CHAUDHURY EXPERT COMMITTEE • • •
CDSCO has published actions proposed to be taken on recommendations given by Prof. Ranjit Roy Chaudhury expert committee Proposal for accreditation of EC and Investigator sites Proposal to set up Technical Review Committees for review of clinical trial applications, with possibility to form regional technical review committees
•
Proposal for actions to be taken for shortening of approval timelines for clinical trials and to make an effort to bring it down to 1 month
•
Actions proposed document is available at following URL: http://www.cdsco.nic.in/Action_RR_ Choudhury_Committee__06.11.2013.pdf.
Website: www.picronline.org
45
•
quantum of compensation in the cases of clinical trial related serious adverse events of deaths occurring during the clinical trials As per the formula proposed the compensation amount will vary from a minimum of Rs. 4 lacs to a maximum of Rs. 73.60 lacs depending on the age of the deceased and the risk factor
AV RECORDING OF INFORMED CONSENT PROCESS •
C DSCO has issued an office order specifying
Perspectives in Clinical Research | January-March 2014 | Vol 5 | Issue 1
Suvarnapathaki: Regulatory update
•
• •
requirement for AV recording of informed consent process AV recording needs to be done for entire process for consenting to include providing information to the subject and understanding of such consent by the subject AV recording of the consent is necessary in addition to the written informed consent Details of the order can be read at following URL: http://www.cdsco.nic.in/Office%20Order%20 dated%2019.11.2013.pdf.
Expected procedural changes Declaration for financial status of the company
Declaration for financial status of the company would now be required for every new application. Such declaration should state some facts about financial reports of the company leading to the conclusion of financial solvency of the applicant. How to cite this article: Suvarnapathaki K. Indian Regulatory Update: September-November 2013. Perspect Clin Res 2014;5:45-6. Source of Support: Nil. Conflict of Interest: None declared.
Announcement
Android App A free application to browse and search the journal’s content is now available for Android based mobiles and devices. The application provides “Table of Contents” of the latest issues, which are stored on the device for future offline browsing. Internet connection is required to access the back issues and search facility. The application is compatible with all the versions of Android. The application can be downloaded from https://market.android.com/details?id=comm.app.medknow. For suggestions and comments do write back to us.
Perspectives in Clinical Research | January-March 2014 | Vol 5 | Issue 1
46
Copyright of Perspectives in Clinical Research is the property of Medknow Publications & Media Pvt. Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Indian Regulatory Update: September‑November 2013
Address for correspondence: Mr. Kedar Suvarnapathaki Boehringer Ingelheim India Pvt. Ltd., 1102, 11th Floor, Hallmark Business Plaza, Bandra (E), Mumbai ‑ 400 051, Maharashtra, India. E‑mail: kedar.suvarnapathaki@ boehringer‑ingelheim.com
This document provides updates in regulatory requirements regarding conduct of clinical trials in India.
CONTRACTS WITH INVESTIGATOR TO BE SUBMITTED TO CENTRAL DRUGS STANDARD CONTROL ORGANIZATION (CDSCO) •
CDSCO has issued an office order to submit copy of clinical trial agreement to be submitted to CDSCO along with every clinical trial application
•
It was subsequently clarified by CDSCO that if such agreement is not available at the time of submitting the application, same can be provided before initiation of study S uch agreement needs to provide details of financial support, fees, honorarium and payments in kind etc. D etails of the order can be read at following URL: http://www.cdsco.nic.in/Furnising%20 of%20information%20in%20respect%20of%20 financial%20 support%202013.pdf.
• •
FORMULA TO DETERMINE THE QUANTUM OF COMPENSATION •
The CDSCO has issued formula to determine the Access this article online Quick Response Code:
•
DOI: 10.4103/2229-3485.124575
T he details about the formula can be accessed at following URL: http://www.cdsco.nic.in/ formula2013SAE.pdf.
ACTIONS ON THE RECOMMENDATIONS OF PROF. RANJIT ROY CHAUDHURY EXPERT COMMITTEE • • •
CDSCO has published actions proposed to be taken on recommendations given by Prof. Ranjit Roy Chaudhury expert committee Proposal for accreditation of EC and Investigator sites Proposal to set up Technical Review Committees for review of clinical trial applications, with possibility to form regional technical review committees
•
Proposal for actions to be taken for shortening of approval timelines for clinical trials and to make an effort to bring it down to 1 month
•
Actions proposed document is available at following URL: http://www.cdsco.nic.in/Action_RR_ Choudhury_Committee__06.11.2013.pdf.
Website: www.picronline.org
45
•
quantum of compensation in the cases of clinical trial related serious adverse events of deaths occurring during the clinical trials As per the formula proposed the compensation amount will vary from a minimum of Rs. 4 lacs to a maximum of Rs. 73.60 lacs depending on the age of the deceased and the risk factor
AV RECORDING OF INFORMED CONSENT PROCESS •
C DSCO has issued an office order specifying
Perspectives in Clinical Research | January-March 2014 | Vol 5 | Issue 1
Suvarnapathaki: Regulatory update
•
• •
requirement for AV recording of informed consent process AV recording needs to be done for entire process for consenting to include providing information to the subject and understanding of such consent by the subject AV recording of the consent is necessary in addition to the written informed consent Details of the order can be read at following URL: http://www.cdsco.nic.in/Office%20Order%20 dated%2019.11.2013.pdf.
Expected procedural changes Declaration for financial status of the company
Declaration for financial status of the company would now be required for every new application. Such declaration should state some facts about financial reports of the company leading to the conclusion of financial solvency of the applicant. How to cite this article: Suvarnapathaki K. Indian Regulatory Update: September-November 2013. Perspect Clin Res 2014;5:45-6. Source of Support: Nil. Conflict of Interest: None declared.
Announcement
Android App A free application to browse and search the journal’s content is now available for Android based mobiles and devices. The application provides “Table of Contents” of the latest issues, which are stored on the device for future offline browsing. Internet connection is required to access the back issues and search facility. The application is compatible with all the versions of Android. The application can be downloaded from https://market.android.com/details?id=comm.app.medknow. For suggestions and comments do write back to us.
Perspectives in Clinical Research | January-March 2014 | Vol 5 | Issue 1
46
Copyright of Perspectives in Clinical Research is the property of Medknow Publications & Media Pvt. Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
