Regulatory Updates Kedar Suvarnapathaki Head Regulatory Affairs, Boehringer Ingelheim India Pvt Ltd, Mumbai India
Indian regulatory update 2013
Address for correspondence: 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.
DRUG TECHNICAL ADVISORY BOARD RECOMMENDED CHANGES IN THE COMPENSATION RULES • The DTAB, the advisory board to the Central Government on technical matters arising out of administration of The Drugs and Cosmetics Act, has during the 63rd meeting held on 16th May 2013 recommended some amendments in the Compensation Rules made effective vide gazette notification issued on 30th January 2013 • Amongst various changes recommended by the board are the recommendations to delete the clause related to compensation due to failure of investigational drug and modify the clause on compensation due to placebo arm to ‘compensation due to placebo, only if standard of care is denied’ • Time frame of reporting serious adverse event (SAE) will continue to be from “occurrence” of the SAE, however to revise SAE reporting timelines from 10 to 14 days to align with international practice • Sponsor will need to continue to pay for investigator negligence and compensation due to adverse effect of concomitant medication excluding standard care as per the recommendations by DTAB • Details of DTAB recommendations can be read at following URL: http://www.cdsco.nic.in/Minutes_63rd_ dtab%20.pdf. Access this article online Quick Response Code:
Website: www.picronline.org DOI: 10.4103/2229-3485.120174
237
REGISTERED INDEPENDENT ETHICS COMMITTEES CAN OVERSEE ONLY BIOAVAILABILITY/BIOEQUIVALENCE (BA/BE) STUDIES, HOWEVER CAN CONTINUE TO OVERSEE ONGOING CLINICAL TRIAL STUDIES THAT WERE APPROVED PRIOR TO EC REGISTRATION • Independent ECs are registered by Central Drugs Standard Control Organization (CDSCO) with the condition restricting them to review and approve only BA/BE studies • The Drug Controller General of India (DCGI) Directorate has issued the notice dated 30‑July‑2013 allowing independent ECs registered by CDSCO for only BA/BE studies oversight to continue overseeing ongoing clinical trials approved by them before registration of EC. However, no new clinical trial can be reviewed and approved by them • The notice dated 30‑July‑2013 can be accessed on following URL: http://www.cdsco.nic.in/notice%20ECR.pdf.
GAZETTE NOTIFICATION FOR AUDIO‑VIDEO RECORDING OF CONSENT PROCESS • Ministry of Health and Family Welfare has issued Gazette notification dated 7‑June‑2013 to publish draft rules to amend the Drugs and Cosmetic Act, 1940 for comments and awareness of all public affected by it to make the provisions for AV recording of informed consent process and the consent itself • The draft notification can be accessed on the following URL: http://www.cdsco.nic.in/GSR%20364 Ejune13.pdf. Expected procedural changes New drug advisory committee referral sets to be submitted along with initial application
To improve CT applications review efficiencies, CDSCO Perspectives in Clinical Research | October-December 2013 | Vol 4 | Issue 4
Suvarnapathaki: Regulatory update
is planning to revise the current CT application process to accept NDAC expert referral sets along with initial application instead of waiting for query to submit the same. This will help in optimizing the timelines for clinical trial approvals. Every clinical trial agreement to be referred to technical and apex ccommittee
Every clinical trial protocol will be referred for review by Technical and Apex committee after the same has been approved by NDAC. Technical Committee and Apex Committee meet once every month. This step may increase the time gap between NDAC meeting and grant of approval letter; however CDSCO also plans to have set timelines for review and approvals of the two expert committees. Prescreening checklist for new CT applications
A new prescreening checklist is being introduced by the Global Clinical Trial Division for all new CT applications.
Undertaking with commitment to file an application to market the drug in India with every CT application. An undertaking from the sponsor to commit to file an application to market the drug in India after the approval and launch of the country in another country. This step is being added to ensure that the Indian population is not perceived as being exploited for clinical trials and assure them of the commercial availability of the drug when approved. Sites should have duly registered EC. New clinical trials can now be conducted only at the investigator sites having an institutional EC registered with CDSCO. The condition of trial site having specific number of beds can be negotiated if the site is overseen by registered EC. Mandatory condition for 50% government sites CDSCO has made it mandatory to have 50% government sites in every protocol approved by them.
All applicants will be required to ensure that the submission dossier is complying with this checklist. Some important points for consideration are:
How to cite this article: Suvarnapathaki K. Indian regulatory update 2013. Perspect Clin Res 2013;4:237-8. Source of Support: Nil. Conflict of Interest: None declared.
Staying in touch with the journal 1) Table of Contents (TOC) email alert Receive an email alert containing the TOC when a new complete issue of the journal is made available online. To register for TOC alerts go to www.picronline.org/signup.asp. 2) RSS feeds Really Simple Syndication (RSS) helps you to get alerts on new publication right on your desktop without going to the journal’s website. You need a software (e.g. RSSReader, Feed Demon, FeedReader, My Yahoo!, NewsGator and NewzCrawler) to get advantage of this tool. RSS feeds can also be read through FireFox or Microsoft Outlook 2007. Once any of these small (and mostly free) software is installed, add www.picronline.org/rssfeed.asp as one of the feeds.
Perspectives in Clinical Research | October-December 2013 | Vol 4 | Issue 4
238
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 2013
Address for correspondence: 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.
DRUG TECHNICAL ADVISORY BOARD RECOMMENDED CHANGES IN THE COMPENSATION RULES • The DTAB, the advisory board to the Central Government on technical matters arising out of administration of The Drugs and Cosmetics Act, has during the 63rd meeting held on 16th May 2013 recommended some amendments in the Compensation Rules made effective vide gazette notification issued on 30th January 2013 • Amongst various changes recommended by the board are the recommendations to delete the clause related to compensation due to failure of investigational drug and modify the clause on compensation due to placebo arm to ‘compensation due to placebo, only if standard of care is denied’ • Time frame of reporting serious adverse event (SAE) will continue to be from “occurrence” of the SAE, however to revise SAE reporting timelines from 10 to 14 days to align with international practice • Sponsor will need to continue to pay for investigator negligence and compensation due to adverse effect of concomitant medication excluding standard care as per the recommendations by DTAB • Details of DTAB recommendations can be read at following URL: http://www.cdsco.nic.in/Minutes_63rd_ dtab%20.pdf. Access this article online Quick Response Code:
Website: www.picronline.org DOI: 10.4103/2229-3485.120174
237
REGISTERED INDEPENDENT ETHICS COMMITTEES CAN OVERSEE ONLY BIOAVAILABILITY/BIOEQUIVALENCE (BA/BE) STUDIES, HOWEVER CAN CONTINUE TO OVERSEE ONGOING CLINICAL TRIAL STUDIES THAT WERE APPROVED PRIOR TO EC REGISTRATION • Independent ECs are registered by Central Drugs Standard Control Organization (CDSCO) with the condition restricting them to review and approve only BA/BE studies • The Drug Controller General of India (DCGI) Directorate has issued the notice dated 30‑July‑2013 allowing independent ECs registered by CDSCO for only BA/BE studies oversight to continue overseeing ongoing clinical trials approved by them before registration of EC. However, no new clinical trial can be reviewed and approved by them • The notice dated 30‑July‑2013 can be accessed on following URL: http://www.cdsco.nic.in/notice%20ECR.pdf.
GAZETTE NOTIFICATION FOR AUDIO‑VIDEO RECORDING OF CONSENT PROCESS • Ministry of Health and Family Welfare has issued Gazette notification dated 7‑June‑2013 to publish draft rules to amend the Drugs and Cosmetic Act, 1940 for comments and awareness of all public affected by it to make the provisions for AV recording of informed consent process and the consent itself • The draft notification can be accessed on the following URL: http://www.cdsco.nic.in/GSR%20364 Ejune13.pdf. Expected procedural changes New drug advisory committee referral sets to be submitted along with initial application
To improve CT applications review efficiencies, CDSCO Perspectives in Clinical Research | October-December 2013 | Vol 4 | Issue 4
Suvarnapathaki: Regulatory update
is planning to revise the current CT application process to accept NDAC expert referral sets along with initial application instead of waiting for query to submit the same. This will help in optimizing the timelines for clinical trial approvals. Every clinical trial agreement to be referred to technical and apex ccommittee
Every clinical trial protocol will be referred for review by Technical and Apex committee after the same has been approved by NDAC. Technical Committee and Apex Committee meet once every month. This step may increase the time gap between NDAC meeting and grant of approval letter; however CDSCO also plans to have set timelines for review and approvals of the two expert committees. Prescreening checklist for new CT applications
A new prescreening checklist is being introduced by the Global Clinical Trial Division for all new CT applications.
Undertaking with commitment to file an application to market the drug in India with every CT application. An undertaking from the sponsor to commit to file an application to market the drug in India after the approval and launch of the country in another country. This step is being added to ensure that the Indian population is not perceived as being exploited for clinical trials and assure them of the commercial availability of the drug when approved. Sites should have duly registered EC. New clinical trials can now be conducted only at the investigator sites having an institutional EC registered with CDSCO. The condition of trial site having specific number of beds can be negotiated if the site is overseen by registered EC. Mandatory condition for 50% government sites CDSCO has made it mandatory to have 50% government sites in every protocol approved by them.
All applicants will be required to ensure that the submission dossier is complying with this checklist. Some important points for consideration are:
How to cite this article: Suvarnapathaki K. Indian regulatory update 2013. Perspect Clin Res 2013;4:237-8. Source of Support: Nil. Conflict of Interest: None declared.
Staying in touch with the journal 1) Table of Contents (TOC) email alert Receive an email alert containing the TOC when a new complete issue of the journal is made available online. To register for TOC alerts go to www.picronline.org/signup.asp. 2) RSS feeds Really Simple Syndication (RSS) helps you to get alerts on new publication right on your desktop without going to the journal’s website. You need a software (e.g. RSSReader, Feed Demon, FeedReader, My Yahoo!, NewsGator and NewzCrawler) to get advantage of this tool. RSS feeds can also be read through FireFox or Microsoft Outlook 2007. Once any of these small (and mostly free) software is installed, add www.picronline.org/rssfeed.asp as one of the feeds.
Perspectives in Clinical Research | October-December 2013 | Vol 4 | Issue 4
238
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.
