Clinical Trial Regulation in India: Recent Updates

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The Central Drugs Standard Control Organization (CDSCO) in India has issued number of guidelines to strengthen clinical trial regulations in India after January 2013. Please find compilation of these guideline to have overall understanding on the same. Click on the hyperlink to get the updates
The recent amendments in schedule Y are• Introduction of Rule 122DAB ¬- Specifying the procedures for payment of compensation to the subjects of the trial in cases of injury or death • Introduction of Rule 122DAC - Specifying various conditions for conduct and inspection of clinical trials• Introduction of Rule 122DD - Specifying the detailed guidelines for registration of Ethics Committee • Drugs and Cosmetics (Amendment) Bill 2013 - Yet to be introduced
Audio-Visual Recording of Consent• Gazette Notification for Audio-Visual recording of informed consent• Audio-Video recording of informed consent has become mandatory
Dr Ranjit Roy Chaudhary Report• Recently Dr Ranjit Roy Chaudhary committee has submitted reports which discuss about practices for conducive environment for growth of clinical trial industry also meeting the regulatory standards.• Actions on the recommendations of prof. Ranjit Roy Chaudhury expert committee to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs
SAE Reporting and CompensationThe process of SAEs reporting in case of injury/death has been revised in recent Schedule Y amendments and below is required information to be submitted along with the SAEs report.• System of Pre-screening for submission of reports of SAEs to CDSCO• Panel of expert for reviewing of SAE of death• Formula to determine the quantum of compensation in the cases of clinical trial related serious adverse events (SAEs) of deaths occurring during clinical trials
Ethics Committee Registration• System for the pre-screening of the applications for registration of ethics committees• IEC in respect of periodic review of ongoing clinical trials• List of Registered Ethics Committees – State Wise
Pre-screening Checklist for Clinical Trial and New Drugs Applications• Read here Supreme Court Proceeding of 30th Sept 2013
Recent Circular related to clinical trials• Furnishing information with respect to financial support to investigator - should be part of clinical trial application• Monitoring of Clinical Trial to all Zonal Offices
Articles on recent regulation for detail reading• Clinical trials: Are we writing-off this noble profession?• Recent Regulatory Amendment in Schedule Y: Impact on Bioequivalence Studies Conducted In India• Recent Changes to Clinical Trial Regulation in India: Focus on Serious Adverse Events, Compensation and Registration of Ethics Committees
Source: Auriga ResearchDCGI Clinical Research Sites Network : Linkedin NetworkCDSCO