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The Quarterly Newsletter from the Corporate of Aurous HealthCare - CRO…
Mar 2014 Vol. 01 Ed. 03
Since 2008…Since 2008…
PROPRIETARY OF AUROUS HEALTHCARE R&D INDIA PRIVATE LIMITED
Dr. VT. Sriraam MBBS MD (Pharmacology) is the founder– director of Aurous HealthCare - CRO. An alumni of Stanley Medical College, he was honored as ―The Best Doctor” by the Ministry of Health, Maldives at the age of 23. Gaining rich and varied experience at top CRO, Dr. VT. Sriraam founded Aurous HealthCare in 2008. An astute medical entreprenuer, his sharp business sense combined with his rich knowledge and experience in the field of clinical research has pushed Aurous HealthCare from strength to strength. He was recently shortlisted as one of the TOP 9 Innovative Entrepreneurs for CavinKare’s Chinnikrishnan Innovation Award 2013. A man with strengths so varied and unique, Dr. VT.Sriraam is the epitome of the entrepreneurial combination of business brains and clinical-research creatives.
Check Your GCP Knowledge…Check Your GCP Knowledge…
1. What are the absolute minimum requirements for essential documents at site before Investigational Product can be sent to clinical trial site? A. Clinical Trial Agreement & CV of Investigator B. Clinical Trial Agreement & Ethics Committee Approval C. Clinical Trial Agreement & Singed Protocol.
2. According to ICH GCP when should a sponsor provide an audit certificate? A. Always B. When audit is successful. C. When required by law or regulation.
3. ICH GCP states that a Sponsor Audit is independent and separate from which of the following? A. Routine Monitoring & Regulatory Audit. B. Site Close out Visit C. Investigator’s Meeting. D. Section 4.8.1 Answers on Page 7
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Recent Amendments in Drugs & Cosmetics Rules, 2013. Recent Amendments in Drugs & Cosmetics Rules, 2013. Continued from page 3.
GSR 364 (E) - 07-Jun-13 Additions to SCHEDULE Y - APPENDIX V - INFORMED CONSENT : Statement mandating the audio video recording of
the informed consent process, statement attesting to possibility of failure of investigational product for its intended
therapeutic use and clearly defined statement that the use of placebo in a placebo-controlled trial will not have any
therapeutic effect.
GSR 588 (E) - 30-Aug-13
New Label format for Schedule H1 - Drug Warning - with Rx symbol and red border.
GSR 702 (E) - 24-Oct-13 Addition to SCHEDULE Y - APPENDIX IB- Data to submitted along with the application to conduct a clinical trial or im-
port or manufacture of a PHYTOPHARMACEUTICAL DRUG in the country.
Definition : "Phytopharmaceutical drug includes processed or unprocessed standardised materials derived from plants
or parts thereof or combination of part of plants or extracts or fractions thereof in a dosage form for internal or external
use of human beings or animals and intended to use for diagnosis, treatment, mitigation or prevention of any disease r
disorder in human beings or animals,but does not include administration by parenteral route."
A two part detailed description of the data that is required to be submitted for the application to conduct a clinical trial
on a phytopharmaceutical drug unless, it has already been marketed for the said indication for more than 5 years.
GSR 703 (E) - 24-Oct-13
Addition of clauses to Schedule C, which mentioned about the educational qualification of the personnel involved in
manufacturing and testing of medical devices.
Addition of rule 109-A: Labeling of Medical Devices. - 15 points that cover the aspects that are mandated in the label-
ing of a medical device during manufacturing and clinical testing.
Addition of rule 109-B: Exemption of certain labeling requirements for medical devices for export from India -
Labels on packages or container of devices for export shall be adopted to meet specific requirement.
1. What is the other common name for osteoporosis?
A. Bone Disease B. Silent Disease
C. Silent Death D. Bone Death
2. What is the most common fracture observed with
osteoporosis?
A. Vertebrae B. Hip
C. Leg D. Hand
3. What is the stage of disease before Osteoporosis
called?
A. Osteopenia B. OsteoFracture
C. Osteodepletion D. OsteoCalcium Loss
4. What is the gold standard test for Osteoporosis?
A. BMD-DEXA scan B. Bone Xray
C. Treadmil Test D. Fracture test
5. What is the daily requirement of Calcium in mg/day
for an adult?
A. 1200mg B. 2000mg
C. 3000mg D. 3200mg
Next Edition: How well do you know Next Edition: How well do you know AYURVEDA??AYURVEDA?? Answers on Page 4
Check Your GCP Knowledge 1.B 2.C 3. A
Aurous HealthCare Aurous HealthCare -- Pioneer in Clinical Studies on Pioneer in Clinical Studies on HerbaceuticalsHerbaceuticals & & Cosmeceuticals:Cosmeceuticals:
THE PIONEER THE PIONEER CONTRACT RESEARCH ORCONTRACT RESEARCH ORGANISATION (CRO) GANISATION (CRO) WITH FOCUS ON CLINICAL RESEARCHWITH FOCUS ON CLINICAL RESEARCH
www. auroushealthcare . wordpress auroushealthcare . wordpress .com The Quarterly Newsletter from AHC The Quarterly Newsletter from AHC -- CROCRO