The Central Drugs Standard Control Organization (CDSCO) in India has issued number of guidelines to strengthen clinical trial regulations in India after January 2013. We have tried to compile these guideline in this mailer to have overall understanding on the same.
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 Compensation
The 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
On behalf of “People for the Advancement of Clinical Research – India”, who have taken the initiative to revive the Clinical Research conduct in India, we would like to request all the Clinical Research Professionals to read the petition, and if you agree with the cause, please sign the petition here
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
We would also like to update our subscribers on the followings
- After conducting three successful events on recent clinical trial regulation we have created a group “Clinical Research Events in India”. Click here to join the group
- Telecast of our recent conference On ‘Adapting to the Current Regulatory Challenges in conduct of Clinical Research – Focus on Sites and Ethics Committees can be viewed on CARE WORLD TV on following timings -27th Nov’13 Wednesday @ 10:45 hrs, 29th Nov’13 [email protected] 14:50 hrs, 1st Dec’13 [email protected] 20:17 hrs. To Watch Care World Live: http://www.careworldtv.com/live/
- Our training partner SenseCR has organized a workshop titled as “Case study based advanced GCP Workshop” on 29th Nov, 2013 at Bawa International Hotel, Near Domestic Airport, Mumbai. Please contact Shilpa Garg at [email protected]
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