AurouSpeak - The quarterly newsletter from Aurous HealthCare CRO Vol 01 Ed 02 | Page 4

AurouSpeak ETHICS COMMITTEE REGISTRATION IN INDIA Continued from Page #3 AURO Ayur… Chavya - Stem of Piper nigrum functioning of the Ethics Committee by Drug Inspectors from both State and Central Office of CDSCO. Sanskrit : Cavika Assamese : Chepaan Bengali : Chei English : Java Long Pepper Gujrati : Chavka, Chavaka Hindi : Chavya Kannada : Chavya Malayalam : Kattumulaku, Kattumulakunveru Marathi : Chavaka ; Oriya : Chainkath; Punjabi : Chabak Tamil : Chavyam, Chevuyam; Telugu : Chevyamu Urdu : Peepal Chab, Kababah; Malayalam: Amalpori, Chuvanna Medicinal uses: Maintenance of records (hard & soft copies) for a  Helps in proper secretion of bile juices from liver.  Beneficial in treating hemorrhoids and fistula.  Corrects metabolic issues and thus aids in weight loss. The following are some of stipulations laid down from the office of DCGI for Ethics Committees across the nation.  The stipulations for review and approval of clinical studies.  The mandates for reporting of Serious Adverse Events as per Schedule Y of D & C Act.  The inspection of the administrative records & period of 5 years. Member constitution, Quorom requirements and mandatory information to the DCGI about change in composition. Issues and resolution of conflict of interest during an ethical review and approval. This move from the CDSCO is seen as the first of the most important decisions in streamlining the process and system of medical research in India. This will pave way for ethical clinical studies and safer tested products in the market!  of the cornea. Ayurvedic Properties and Action:.  Rasa: Katu  Guna: Laghu, Rukha, Tiksna  Virya: Usna  Vipaka: Katu  Karma: Bhedana, Dipana, Kaphahara, Pacana, Recana, Vatahara. Dose: 1-2g of the drug in powder form. Ref : The Ayurvedic Pharmacopeia of India - Part I - Volume II Clinical Trial Management Services Aurous HealthCare– CRO: AHC provides a complete package of comprehensive trial management services for End to End Clinical Projects for New Chemical Entity, Chemical Entity, Herbal Medicines, Nutraceuticals, Cosmeceuticals - through our Clinical Trial Project Management services inclusive of contracts, budget management, logistics control and coordination, Vendor management, Site Management Services for the successful completion of the project including Clinical Study report. We also offer exclusive Site Management Services. Contact : [email protected] or at [phone] We also offer Clinical Trial Rescue Services to help mend strained Sponsor—CRO relationships, issue analysis at Clinical Trial Site, Medical monitoring services and independent quality AuroQuiz answers: 1.B 2.B. 3. James Lind - Scurvy Trial www.auroushealthcare.com #4