AurouSpeak - The quarterly newsletter from Aurous HealthCare CRO Vol 01 Ed 02 | Page 3

AurouSpeak ETHICS COMMITTEE REGISTRATION IN INDIA Inside… On 8th February 2013, DCGI officially announced the III Amendment to the Drugs and Cosmetics Act , 1945; and with RULE 122DD , the CDSCO mandated the registration of Ethics Committees all across the country. A welcome move by researchers across the country, this was seen as the one of the most positive moves by the CDSCO in streamlining the process of clinical research in India. Apart from the Scope of an Ethics Committee, Appendix XII of Schedule Y elucidated the Composition of EC - member details, quorum requirements, gender and educational balance and representation along with resolution of conflict of interest; Application Information - constitutive and administrative details of the EC. Every functioning Ethics Committee in India was required to submit an elaborate application to the office of DCGI, which included information about constitution, composition of the committee inclusive of member appointment, terms of reference, replacement and resignation procedures. Elaborate details of the clinical trial proposals reviewed by the committee thus far along with their Standard Operating Procedures and documentation regarding approvals, minutes of meetings, reviews and audits of investigator sites were also required to be submitted to the DCGI. The initiative thus gave way to the registration and approval for functioning of ethics committees as Independent EC or Institutional EC. Each of these committee registrations came with their own rules and stipulations from the office of DCGI The process has been stringent and demanding, but AURO Ayur………………...………..…Page 4 Malarial Vaccine Trial………..…Page 5 AURO BYTE………………...………..…Page 5 Risk based monitoring………..…Page 6 AURO Days………………...………….Page 6 Exercise = Drugs………...………..…Page 7 AURO BLOG!!! For details ...Page 8 AurouSpeak in your INBOX !!! the information that our Universal Ethics Committee Send a test mail and receive quarterly updates on Clinical Trials and Drug Research in your inbox! has been registered with the office of DCGI - CDSCO holding the registration number [email protected] [email protected] we at Aurous HealthCare are happy and proud to share ECR/125/Indt/TN/2013, with a validity of three years from Oct, 2013. Register! (continued on Page #4) www.auroushealthcare.com #3