Regulatory Updates Kedar Suvarnapathaki Head Regulatory Affairs, Boehringer Ingelheim India Pvt. Ltd., Mumbai, Maharashtra, India
Indian Regulatory Update: January-March 2015
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.
AMENDED COMPENSATION RULES ‑ GSR 889 (E) RELEASED • Central Drugs Standard Control Organisation (CDSCO) has issued amended compensation rules providing more clarity on the definition of the term “related to clinical trials (CT)” • Clarifications provided for serious adverse event (SAE) reporting timelines to specify that in case of SAE not reported within 24 h of occurrence, the investigator needs to provide reasons for the same • Notification also provides better clarity on various other aspects of the compensation rules, the gazette notification can be accessed at following URL: http://www.cdsco.nic.in/writereaddata/ Notificatiohn%20on%20Compensation%20on%20 clincial%20trial%20 (1).pdf.
DRAFT DRUGS AND COSMETICS (AMENDMENT) BILL, 2015 • Draft Drugs and Cosmetics (Amendment) bill 2015 has been released for public comments • The bill makes the provision for CT under Drugs and Cosmetics Act Access this article online Quick Response Code:
Website: www.picronline.org DOI: 10.4103/2229-3485.154018
Perspectives in Clinical Research | April-June 2015 | Vol 6 | Issue 2
• Provisions also made for import, manufacture, and CT with devices • The bill also makes the provisions for CT with cosmetics • Penalties have been proposed for various offences like conduct of CT without permission from licensing authority and Expert Committee (EC), violation of conditions of clinical trial permission, not providing compensation, etc • Bill makes the provisions for appeal mechanisms for parties aggrieved by the orders under the amended act as well • Complete draft of the bill can be accessed at following URL: http://www.cdsco.nic.in/writereaddata/D and %20C%20AMMENDMENT%20BILL%281%29.pdf.
DRUGS AND COSMETICS (THIRD AMENDMENT) RULES 2015 • Draft amendment of D and C rules as per GSR 69(E) has been released by CDSCO • The amendment omits Rule 122DAA which defines a clinical trial, and the definition of clinical trial has been provided as part of the explanation to Rule 122DA • The amendment also defines certain terms such as global clinical trial (GCT), IND, and new chemical entity (NCE) as part of the explanation to Rule 122DA along with definition of CT • Amendment makes the provision for providing information regarding “assessment of risk versus benefit to patients,” “innovation vis‑à‑vis existing therapeutic option,” and “unmet medical need in the country” mandatory as part of form 44 and Appendix I of Schedule Y • Draft notification can be accessed at following URL: http://www.cdsco.nic.in/writereaddata/G_S_R_%20 69(E).pdf. 118
Suvarnapathaki: Regulatory update
DRAFT STANDARDS AND APPLICATION FORMAT FOR ACCREDITATION OF ETHICS COMMITTEE, INVESTIGATOR AND CLINICAL TRIAL SITE • CDSCO has issued draft standards for accreditation of EC and sites as per recommendations of an EC under the Chairmanship of Prof. Ranjit Roy Chaudhury • The Ministry of Health and Family Welfare decided to assign the job of accreditation to Quality Council of India • The Accreditation Standards and format for application for Accreditation prepared by Quality Council of India are uploaded on CDSCO website for comments/ suggestions of stakeholders • Accreditation standards and formats can be accessed at following URL: http://cdsco.nic.in/forms/list. aspx?lid=2074 and Id=23.
PRESUBMISSION MEETINGS PROPOSED TO BE INITIATED BY CENTRAL DRUGS STANDARD CONTROL ORGANISATION • CDSCO has decided to introduce a system of formal Presubmission Meetings of applicants with CDSCO officers and subject experts to discuss regulatory pathway in respect of specific application for approval of clinical trial, new drug, medical device etc • The system will facilitate to understand the regulatory pathways required to be followed by the applicants for approvals resulting in bringing transparency, accountability, predictability, and speedy disposal of cases • Notice inviting comments for the proposal was issued by CDSCO, the same can be accessed at following URL: http://www.cdsco.nic.in/writereaddata/NOTICE15.pdf. How to cite this article: Suvarnapathaki K. Indian Regulatory Update: January-March 2015. Perspect Clin Res 2015;6:118-9 Source of Support: Nil. Conflict of Interest: None declared.
Author Help: Online submission of the manuscripts Articles can be submitted online from http://www.journalonweb.com. For online submission, the articles should be prepared in two files (first page file and article file). Images should be submitted separately. 1) First Page File: Prepare the title page, covering letter, acknowledgement etc. using a word processor program. All information related to your identity should be included here. Use text/rtf/doc/pdf files. Do not zip the files. 2) Article File: The main text of the article, beginning with the Abstract to References (including tables) should be in this file. Do not include any information (such as acknowledgement, your names in page headers etc.) in this file. Use text/rtf/doc/pdf files. Do not zip the files. Limit the file size to 1 MB. Do not incorporate images in the file. If file size is large, graphs can be submitted separately as images, without their being incorporated in the article file. This will reduce the size of the file. 3) Images: Submit good quality color images. Each image should be less than 4096 kb (4 MB) in size. The size of the image can be reduced by decreasing the actual height and width of the images (keep up to about 6 inches and up to about 1800 x 1200 pixels). JPEG is the most suitable file format. The image quality should be good enough to judge the scientific value of the image. For the purpose of printing, always retain a good quality, high resolution image. This high resolution image should be sent to the editorial office at the time of sending a revised article. 4) Legends: Legends for the figures/images should be included at the end of the article file.
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Perspectives in Clinical Research | April-June 2015 | Vol 6 | Issue 2
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: January-March 2015
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.
AMENDED COMPENSATION RULES ‑ GSR 889 (E) RELEASED • Central Drugs Standard Control Organisation (CDSCO) has issued amended compensation rules providing more clarity on the definition of the term “related to clinical trials (CT)” • Clarifications provided for serious adverse event (SAE) reporting timelines to specify that in case of SAE not reported within 24 h of occurrence, the investigator needs to provide reasons for the same • Notification also provides better clarity on various other aspects of the compensation rules, the gazette notification can be accessed at following URL: http://www.cdsco.nic.in/writereaddata/ Notificatiohn%20on%20Compensation%20on%20 clincial%20trial%20 (1).pdf.
DRAFT DRUGS AND COSMETICS (AMENDMENT) BILL, 2015 • Draft Drugs and Cosmetics (Amendment) bill 2015 has been released for public comments • The bill makes the provision for CT under Drugs and Cosmetics Act Access this article online Quick Response Code:
Website: www.picronline.org DOI: 10.4103/2229-3485.154018
Perspectives in Clinical Research | April-June 2015 | Vol 6 | Issue 2
• Provisions also made for import, manufacture, and CT with devices • The bill also makes the provisions for CT with cosmetics • Penalties have been proposed for various offences like conduct of CT without permission from licensing authority and Expert Committee (EC), violation of conditions of clinical trial permission, not providing compensation, etc • Bill makes the provisions for appeal mechanisms for parties aggrieved by the orders under the amended act as well • Complete draft of the bill can be accessed at following URL: http://www.cdsco.nic.in/writereaddata/D and %20C%20AMMENDMENT%20BILL%281%29.pdf.
DRUGS AND COSMETICS (THIRD AMENDMENT) RULES 2015 • Draft amendment of D and C rules as per GSR 69(E) has been released by CDSCO • The amendment omits Rule 122DAA which defines a clinical trial, and the definition of clinical trial has been provided as part of the explanation to Rule 122DA • The amendment also defines certain terms such as global clinical trial (GCT), IND, and new chemical entity (NCE) as part of the explanation to Rule 122DA along with definition of CT • Amendment makes the provision for providing information regarding “assessment of risk versus benefit to patients,” “innovation vis‑à‑vis existing therapeutic option,” and “unmet medical need in the country” mandatory as part of form 44 and Appendix I of Schedule Y • Draft notification can be accessed at following URL: http://www.cdsco.nic.in/writereaddata/G_S_R_%20 69(E).pdf. 118
Suvarnapathaki: Regulatory update
DRAFT STANDARDS AND APPLICATION FORMAT FOR ACCREDITATION OF ETHICS COMMITTEE, INVESTIGATOR AND CLINICAL TRIAL SITE • CDSCO has issued draft standards for accreditation of EC and sites as per recommendations of an EC under the Chairmanship of Prof. Ranjit Roy Chaudhury • The Ministry of Health and Family Welfare decided to assign the job of accreditation to Quality Council of India • The Accreditation Standards and format for application for Accreditation prepared by Quality Council of India are uploaded on CDSCO website for comments/ suggestions of stakeholders • Accreditation standards and formats can be accessed at following URL: http://cdsco.nic.in/forms/list. aspx?lid=2074 and Id=23.
PRESUBMISSION MEETINGS PROPOSED TO BE INITIATED BY CENTRAL DRUGS STANDARD CONTROL ORGANISATION • CDSCO has decided to introduce a system of formal Presubmission Meetings of applicants with CDSCO officers and subject experts to discuss regulatory pathway in respect of specific application for approval of clinical trial, new drug, medical device etc • The system will facilitate to understand the regulatory pathways required to be followed by the applicants for approvals resulting in bringing transparency, accountability, predictability, and speedy disposal of cases • Notice inviting comments for the proposal was issued by CDSCO, the same can be accessed at following URL: http://www.cdsco.nic.in/writereaddata/NOTICE15.pdf. How to cite this article: Suvarnapathaki K. Indian Regulatory Update: January-March 2015. Perspect Clin Res 2015;6:118-9 Source of Support: Nil. Conflict of Interest: None declared.
Author Help: Online submission of the manuscripts Articles can be submitted online from http://www.journalonweb.com. For online submission, the articles should be prepared in two files (first page file and article file). Images should be submitted separately. 1) First Page File: Prepare the title page, covering letter, acknowledgement etc. using a word processor program. All information related to your identity should be included here. Use text/rtf/doc/pdf files. Do not zip the files. 2) Article File: The main text of the article, beginning with the Abstract to References (including tables) should be in this file. Do not include any information (such as acknowledgement, your names in page headers etc.) in this file. Use text/rtf/doc/pdf files. Do not zip the files. Limit the file size to 1 MB. Do not incorporate images in the file. If file size is large, graphs can be submitted separately as images, without their being incorporated in the article file. This will reduce the size of the file. 3) Images: Submit good quality color images. Each image should be less than 4096 kb (4 MB) in size. The size of the image can be reduced by decreasing the actual height and width of the images (keep up to about 6 inches and up to about 1800 x 1200 pixels). JPEG is the most suitable file format. The image quality should be good enough to judge the scientific value of the image. For the purpose of printing, always retain a good quality, high resolution image. This high resolution image should be sent to the editorial office at the time of sending a revised article. 4) Legends: Legends for the figures/images should be included at the end of the article file.
119
Perspectives in Clinical Research | April-June 2015 | Vol 6 | Issue 2
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.
