Post on 18-Apr-2018
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
© Aurous HealthCare R&D India Private Limited, 2008, All Rights Reserved
The pioneer Contract Research Organisation (CRO) with focus on Clinical Research
http://auroushealthcare.wordpress.com/dr-vt-sriraam/
From the Desk of MD…
As a medical entrepreneur, I am excited like a child on his birthday that the dawn of another
financial year looms close.
Our AURO-BLOG has been religiously capturing the pulse of the Drug Research Industry and it
thrills me to see the progress we are making towards a more regulated and scientifically advanced world.
The happiness also stems from the very promising activity in the sphere of AYUSH!
The world is travelling back to its ancient roots and the foray of herbal cosmetics with natural
extracts and ingredients, is the most fascinating progress of recent times. AYURVEDA and SIDDHA is
making it’s presence felt with safer, milder herbal medicines and cosmetics. As a doctor from the school of
modern medicine and surgery, it prides me that the most ancient science of our land is being reinvented to
match the standards of modern science and provide the safest and most suitable care to our health.
It is interesting to note that Clinical Studies are no longer feared upon as an experimentation but
are being considered as the medically apt scientific approach to ensuring the safety and efficacy of
your product - even an AYURVEDIC or SIDDHA formulation that has been around for years -
before it reaches the larger public.
With Best Regards, Dr. VT. Sriraam MBBS MD (Pharmacology)
ManagingDirector | Medical director—Aurous HealthCare– CRO
**************************************************************************************************************
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.
AurouSpeak
#2
Inside…Inside…
AURO Ayur………………...………..…Page 4
POLIO FREE INDIA!!......………..…Page 5
AURO BYTE………………...………..…Page 5
AURO- DAYS………………………..…Page 6
USFDA Commissioner visits……..Page 7
More from AUROBLOG..………..…Page 7
AurouSpeak
in your INBOX !!!
Send a test mail and receive quarterly updates
on Clinical Trials and Drug Research in your
inbox!
mgr.bd@auroushealthcare.com corporate@auroushealthcare.com
Register!Register!
AurouSpeak
#3 www.auroushealthcare.com
The following are the major amendments in the Drugs & Cosmetics
Rules - 2013 pertaining to the field of clinical research...
GSR 53(E) - 30-Jan-13 Addition of the above following details in SCHEDULE Y, as a clause
to "Responsibilities of Sponsor", "Responsibilities of Ethics
Committee" and additions of responsibilities and reporting
timelines to Ethics Committee and Licensing Authority as
"Responsibilities of Investigator"
Additions to SCHEDULE Y - APPENDIX V - INFORMED
CONSENT : Statement mentioning medical management and
financial compensation. Addition to informed consent document
that captures the name and contact details of the subject's
nominee.
Addition of Rule 122 DAB - Compensation in case of injury or
death during clinical trial.
7 points were added highlighting important aspects such as free
follow up medical management, subject/nominee may also be
entitled to financial compensation as borne by the sponsor and the
criteria for deciding on the factors of injury and their association
with the clinical trial or the investigational products.
Addition of APPENDIX XII to SCHEDULE Y : Compensation
incase of injury or death during clinical trial. 6 points that outline
the details of handling and reporting a serious adverse event
during a clinical trial.
GSR 63 (E) - 01-Feb-13 Addition of Rule 122 DAC - Permission to conduct clinical
trial.
The points that were added stressed on conduction of clinical
trials in compliance with Schedule Y and Good Clinical Practice
guidelines, the importance of obtaining Ethics Committee approval
and registering the clinical trial with CTRI - Clinical Trial Registry -
India before enrolling the first subject into the trial.
The rule also stresses the submission of annual reports, timely and
apt reporting of serious adverse events to the regulatory
authorities.
GSR 72 (E) - 08-Feb-13 Addition of Rule 122 DD - Registration of Ethics Committee.
A detailed account of the composition, conduct and registration of
the Ethics Committees in India, which would help the CDSCO, keep
a vigilant check on the ethical aspect of the clinical trials
conducted in India and the specific bodies approving the same. Continued on page 6...
Recent Amendments in Recent Amendments in
Drugs & Cosmetics Rules, 2013. Drugs & Cosmetics Rules, 2013.
AurouSpeak
#4
AURO Ayur…AURO Ayur…
Madana...
Scientific name: dried fruit
of Xeromphis spinosa
Sanskrit : Madani
Assamese : Maen
Bengali : Mayanaphal
English : Emetic nut
Gujrati : Mindhol
Hindi : Manphal
Kannada : Mangarikkai, Karigidda
Malayalam : Malankara; Marathi : Ghalphala
Tamil : Marukarrai; Telugu : Monga Kaya; Urdu : Mainphal
Medicinal uses:
Main use is that as an emetic agent.
In smaller doses it is a nauseant, expectorant and diaphoretic.
In smaller doses for the teething problems of infants.
Also credited with antihelminthic properties.
Applied externally for rheumatic pain.
Ayurvedic Properties and Action:.
Rasa: Madura, Tikta
Guna: Laghu, Rukha.
Virya: Usna
Vipaka: Katu
Karma: Vamana, Lekhana
Dose: 1-2g of the drug in powder form. Ref : The Ayurvedic Pharmacopeia of India - Part I - Volume I
Contact : Contact : mgr.bd@auroushealthcare.com +91mgr.bd@auroushealthcare.com +91--98409091559840909155
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 audit services.
AuroQuiz answers: 1.B 2.B. 3A. 4A. 5A. www.auroushealthcare.com
D A PRASANNA ELECTED AS ACRO
INDIA’S NEW CHAIRMAN… The Association of Contract
Research Organizations
(ACRO) India has
unanimously elected D A
Prasanna, founder and
chairman Ecron Acunova, as
the chairman of the
Association.
He took over from Apurva
Shah, group managing director, Veeda Clinical
Research Pvt. Ltd.
Speaking on the appointment, D A Prasanna
said that clinical research in India has contributed
to bringing vaccines, drugs, devices to needy
patients at affordable prices. From neglected
diseases like kala azar to tropical disease like
malaria, Indian clinical research has alleviated
suffering. India has made a name in the world in
lowering healthcare costs through generics and
building a reputation in development of biotech
drugs and medical devices. ACRO India’s priority is
to promote safe conduct of clinical research without
impeding the development of much needed drugs
for Indian patients and to make Indian research
data useful to market drugs across the world. Source: PharmaBiz...
AurouSpeak
#5
AURO Byte… AURO Byte…
BLAST: Basic Local Alignment Search ToolBLAST: Basic Local Alignment Search Tool
www.ncbi.nlm.nih.gov/BLAST/
The Basic Local Alignment Search Tool (BLAST) finds regions of local similarity between
sequences. The program compares nucleotide or protein sequences to sequence databases and
calculates the statistical significance of matches. BLAST can be used to infer functional and
evolutionary relationships between sequences as well as help identify members of gene
families. A BLAST search enables a researcher to compare a query sequence with a library or database of sequences, and identify library
sequences that resemble the query sequence above a certain threshold. The BLAST program was designed by Stephen Altschul,
Warren Gish, Webb Miller, Eugene Myers, and David J. Lipman at the National Institute of Health in 1990.
www.auroushealthcare.com
WHO DECLARES INDIA POLIO FREE… India was once recognized as the world’s
epicentre of polio. But there has not been a
single recorded case of polio in India since 13
Jan 2011. All pending laboratory investigations
have returned negative, in the coming weeks India
will officially be deemed to have stopped
indigenous transmission of wild poliovirus.
“India’s success is arguably its greatest
public health achievement and has provided a
global opportunity to push for the end of polio,”
said WHO Director-General Margaret Chan.
“The Global Polio Eradication Initiative is in full
emergency mode and focused on using this
momentum to close this crippling disease down.
Stopping polio in India required creativity, perseverance and professionalism – many of the innovations in polio
eradication were sparked by the challenges in India. The lessons from India must now be adapted and implemented
through emergency actions to finish polio everywhere.”
The key to India’s remarkable progress in the fight against polio according to UNICEF Executive Director
Anthony Lake, has been the strong leadership of the Government of India and state governments, which launched a
comprehensive polio eradication programme that has enabled sustained high immunization coverage in states like Uttar
Pradesh and Bihar with high rates of poverty, high population density and poor sanitation and infrastructure, conditions
in which disease like polio can thrive.
“India’s achievement is proof positive that we can eradicate polio even in the most challenging environments –
in fact, it is only by targeting these areas that we can defeat this evil disease,” Mr Lake said. “We have the ability to protect
every last person, especially
children, from this entirely prevent-
able disease – and because we can,
we must finish the job of eradicating
polio globally, once and for all.”
Th e G l o ba l P ol io
Eradication Initiative (GPEI) is
spearheaded by national govern-
ments, WHO, Rotary International,
the US Centers for Disease Control
and Prevention (CDC) and UNICEF.
AurouSpeak
#6
Universal Ethics Committee: Universal Ethics Committee: The Ethics Committee Division of The Ethics Committee Division of Aurous HealthCare Aurous HealthCare -- CRO…CRO…
Universal Ethics Committee (UEC), is a unit of Aurous HealthCare (CRO) that is registered with
CDSCO-DCGI holding registration number ECR/125/Indt/TN/2013 ECR/125/Indt/TN/2013 & OHRP (Office of Human Rights Pro-
tection, Unites States) - IRB00008683. UEC has been serving the Clinical Research fraternity since 2012 by provid-
ing guidance for conduct and ethical clearance for clinical trial projects. Equipped with a GCP and
Schedule Y compliant Expert member team, UEC contributes to the conduct of justified human (clinical) trials. We
also review and approve PMS studies...
Contact : universalethicscommittee@gmail.com or via +91Contact : universalethicscommittee@gmail.com or via +91--98409091559840909155
AURO Days…AURO Days…
APRIL:APRIL:
7 : World Health Day
17 : World Hemophilia Day
25 : World Malaria Day
MAY:MAY:
6 : World Asthma Day.
8 : World Red Cross Day.
12 : International Nurses Day.
17 : World Hypertension Day
JUNEJUNE
14 : World Blood
Donation Day
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
www.auroushealthcare.com
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.
AurouSpeak
#7
AURO Quiz… AURO Quiz… Osteoporosis . . .Osteoporosis . . .
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:
①① Cost Effective Research!Cost Effective Research!
② Customised Clinical Trial Design!② Customised Clinical Trial Design!
③ ③ World Health Organisation World Health Organisation
&& ICMR Listing for YOUR company!ICMR Listing for YOUR company!
④ Specialised Medical Writing!④ Specialised Medical Writing!
⑤ Internationally Accepted Reports!⑤ Internationally Accepted Reports!
⑥ End to End Study & Regulatory Aid!⑥ End to End Study & Regulatory Aid!
Contact : mgr.bd@auroushealthcare.com or +91Contact : mgr.bd@auroushealthcare.com or +91--98409091559840909155
www.auroushealthcare.com
USFDA COMMISSIONER MARGARET HAMBURG VISITED INDIA…
USFDA Commissioner Dr. Margaret A Hamburg, visited India to hold discussions
with her Indian counterparts and industry leaders on maintaining high-quality standards in
producing drugs. During her trip, she addressed the World Spice Congress in Cochin and
visited spice and seafood processing plants. Between the dates of February 10 and 18 this
year, she also visited Delhi and Mumbai to strengthen cooperation between the FDA and its
Indian regulatory counterparts.
Dr. Hamburg also met with the officials of Marine Products development Authority
in Delhi and Cochin. The USFDA have recently brought in the Food Safety Modernisation Act
(FSMA), which has considerably changed the whole approach of FDA by putting more onus
on food importers to the country. Her visit also held a background of concerns regarding the quality of medicine, spices
and seafood being exported from India to the US. The visit by Dr.Hamburg was an official one which served to further
strengthen the ties with USFDA with respect to drug research in India. Source: Times of India...
More from AUROMore from AURO--BLOG...BLOG...
Steps taken by CDSCO to strengthen clinical trials.
CDSCO to focus on strengthening Pharmacovigilance in 2014.
CDSCO approved must be sought for BA-BE bioanalytical lab
facility.
Rule 96 of D&C Act to be amended to make vaccine based
products as “new drugs”.
Schedule M to be made on par with WHO-GMP very soon.
CDSCO and UDFDA sign letter of intent.
ICMR finalized guidelines on “STEM CELL RESEARCH”.
ICMR published CODE OF CONDUCT GUIDELINES FOR LIFE
SCIENCE RESEARCH SCIENTISTS”.
GLOBAL AYURVEDA FESTIVAL at Cochin a HUGE SUCCESS! -
Dignitaries and eminents from the national and international
scenario took part in the glorious 5 day event!
Details of these posts and more on Details of these posts and more on
www . auroushealthcare . wordpress . comwww . auroushealthcare . wordpress . com
AUROUS HEALTHCARE RESEARCH AND DEVELOPMENT INDIA PRIVATE LIMITED
(Formerly Auroville HealthCare R & D India Pvt Ltd.)
#180/109, Rangarajapuram Main Road, Kodambakkam, Chennai-600024.
Phone: +91-44 23720600, +91-44 32472446 • Mobile: +91 9551050612 Fax: +91-4423720600
contact@auroushealthcare.com mgr.bd@auroushealthcare.com www.auroushealthcare.com
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
Subscribe : Send an email to Subscribe : Send an email to mgr.bd@auroushealthcare.com mgr.bd@auroushealthcare.com today...today...