Perspectives in Clinical Research

: 2015  |  Volume : 6  |  Issue : 2  |  Page : 118--119

Indian Regulatory Update: January-March 2015

Kedar Suvarnapathaki 
 Head Regulatory Affairs, Boehringer Ingelheim India Pvt. Ltd., Mumbai, Maharashtra, India

Correspondence Address:
Kedar Suvarnapathaki
Boehringer Ingelheim India Pvt. Ltd., 1102, 11th Floor, Hallmark Business Plaza, Bandra (E), Mumbai - 400 051, Maharashtra

How to cite this article:
Suvarnapathaki K. Indian Regulatory Update: January-March 2015.Perspect Clin Res 2015;6:118-119

How to cite this URL:
Suvarnapathaki K. Indian Regulatory Update: January-March 2015. Perspect Clin Res [serial online] 2015 [cited 2021 Jul 24 ];6:118-119
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Full Text

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 sameNotification also provides better clarity on various other aspects of the compensation rules, the gazette notification can be accessed at following URL: (1).pdf.

 Draft Drugs and Cosmetics (Amendment) Bill, 2015

Draft Drugs and Cosmetics (Amendment) bill 2015 has been released for public commentsThe bill makes the provision for CT under Drugs and Cosmetics ActProvisions also made for import, manufacture, and CT with devicesThe bill also makes the provisions for CT with cosmeticsPenalties 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, etcBill makes the provisions for appeal mechanisms for parties aggrieved by the orders under the amended act as wellComplete draft of the bill can be accessed at following URL: 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 CDSCOThe 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 122DAThe 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 CTAmendment 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 YDraft notification can be accessed at following URL:

 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 ChaudhuryThe Ministry of Health and Family Welfare decided to assign the job of accreditation to Quality Council of IndiaThe Accreditation Standards and format for application for Accreditation prepared by Quality Council of India are uploaded on CDSCO website for comments/suggestions of stakeholdersAccreditation standards and formats can be accessed at following URL: 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 etcThe 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 casesNotice inviting comments for the proposal was issued by CDSCO, the same can be accessed at following URL: