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The quarterly newsletter from the Corporate of Aurous HealthCare - CRO.

Sep 2013 Vol. 01 Ed.01





Since 2008 Since 2008 Since 2008
PROPRIETARY OF AUROUS HEALTHCARE R&D INDIA PRIVATE LIMITED
Aurous HealthCare R&D India Private Limited, 2008, All Rights Reserved





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
From the Desk of MD...
Dear,
Aurous HealthCareCRO turns 5 today! And it gives me immense pleasure to bring this
joyous news to you!

Looking back, it surprises me that 5 years have flown by.

My baby Aurous HealthCareCRO has seen various milestones in her travel and we are
happy that AurouSpeak - our quarterly newsletter - is one that I get to share with you.

The sphere of drug researchin particularclinical research has seen multitude of changes
and updates in the past year. In this issue of AurouSpeak we attempt to bring to your desk the
news that have made an impact in the world of clinical research recently.

Time is right to make the best use of the advancements and opportunities that science and
technology has to give us.

. And I have promises to keep,
And miles to go before I sleep..
And miles to go before I sleep..

With Best Regards,




Dr. VT. Sriraam MBBS MD (Pharmacology)
ManagingDirector | Medical directorAurous 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 technocrat, 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 CavinKares
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
www.auroushealthcare.com


Inside

Mini Water Treatment..Page 4

AURO Ayur...... Page 4

AURO Byte...... Page 5

USFDA - Medical Devices. Page 6

AURO Days...... Page 6

GCP for ASU Medicines..... Page 7

AURO Quiz...... Page 7



WHOAPPROVESINDIASDRUG
REGULATORYSYSTEM...

The World Health Organization has cleared India's


vaccine regulatory system for maintaining International
standards,pavingthewayforeasyexportofvaccinesproduced
in the country. The National Regulatory Authority of India
(NRA) and its affiliated institutions now meet WHO efficacy
indicators for a functional vaccine regulatory system, after a
WHO team of international experts from eight countries
conducteditscomprehensivereviewinDecemberlast.

India's Rs 19,000crore
vaccine industry accounts for
exports worth 13 billion US
dollars to 150 countries. India is
a major vaccine producer that
has 12 major vaccine
manufacturingfacilities.
In2012,Indiahadseven
vaccine manufacturers producing 67 prequalified vaccines
(dosageforms).Currently16vaccinesareprequalifiedbyWHO
and exported through United Nations agencies. More than
70percentofallmeaslesvaccinesusedgloballyareproducedin
India.
WHO assessment of a regulatory authority as
functional means the country's vaccine production lines are
efficaciousandsafeandcaneasilybetrusted.Witharegulatory
system for vaccines assessed as functional by WHO, vaccine
manufacturers in India continue to remain eligible to apply for
prequalificationofspecificproducts.
WHO prequalification,
whichisaguaranteethata
specific vaccine meets
international standards of
quality, safety and effi
cacy, is a prerequisite for
manufacturers to supply
to countries through
United Nations procuring
agencies
Ref:TheEconomicTimes
AurouSpeak
in your INBOX !!!
Sendatestmailandreceivequarterlyup
datesonClinicalTrialsandDrugResearch
inyourinbox!

corporate@auroushealthcare.com

Register!
#3
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AURO Ayur
RauvolfiaSerpentina
Hindi:Chhotachand,
Harkaichanda,Nai,
Nakulikanda
Marathi:Harkaya,
Karki,Mungusavel,
Sapasanda
English:Indiansnake
root.Serpentineroot
Sanskrit:Sarpagandha,
Chandrika,Nakuli,Sarpadani,Kukkudi,Raktatrika
Tamil:Patalagandhi,Patalagaruda,Sovannamilbori
Malayalam:Amalpori,Chuvannaamalpori
Medicinaluses:
Centralnervoussystemdisordersassociatedwithpsychosis,
schizophrenia,insanity,insomnia,andepilepsy.
Extractsoftherootsarevaluedforthetreatmentofintestinal
disorders,particularlydiarrheaanddysenteryandalsoas
anathematic.
Thejuiceoftheleaveshasbeenusedasaremedyforopacity
ofthecornea.
Sideeffects:
Overdosecausegiddinessandistoxic.
Ref:Odhisha Forest Development Corporation
MINIWATERTREATMENTPLANTINA
PACKET
They call it a mini
wat er t r eat ment
plant in a packet.
The powder essen
tially performs the
job of a municipal
treatment facility
but on a much
smallerandportable
scale.
The chemistry is
impressive, yet the
application is
incredibly simple. It
involves pouring the
contents of one
packet, which
weighs less than an
ounce, into a bucket of 10 quarts of water and stirring.
Dirt,parasitesandothermaterialdroptothebottom,and
diseasecausingmicrobesdie.
To meet the program goal of saving one life every hour by
2020, P&G has established a threepronged strategy, with one
stepalreadycomplete.InNovember2012,theyfinishedbuild
ing a new facility in Singapore to ramp up production of the
waterpurifierpackets.
Additionally, CSDW, which has worked in 71 countries, plans
to expand distribution even further. They also plan to invest
more in raising public awareness of the need for clean
drinkingwater.
A u r o Q u i z a n s w e r s : 1 . B 2 . A . 3 . D r . B a l K r i s h n a n A n a n d
ClinicalTrialManagementServicesfromAurousHealthCareCRO:
AHC providesacompletepackageofcomprehensivetrialmanagementservicesforEnd to End Clinical Projects for New
Chemical Entity, Chemical Entity, Herbal Medicines, Nutraceuticals, Cosmeceuticals through our ClinicalTrialProject
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
exclusiveSiteManagementServices.

Contact:mgr.bd@auroushealthcare.comorat+919551050612
#4
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AURO Byte
www.fold.it
Folditisanonlinepuzzlevideogameaboutproteinfolding.Thegameis
part of an experimental research project, and is developed by the
University of Washington's Center for Game Science in collaboration
with the UW Department of Biochemistry. The objective of the game is
to fold the structure of selected proteins as well as possible, using
various tools provided within the game. The highest scoring solutions
are analysed by researchers, who determine whether or not there is a native structural configuration (or native state) that
can be applied to the relevant proteins, in the "real world". Scientists can then use such solutions to solve "realworld"
problems,bytargetinganderadicatingdiseases,andcreatingbiologicalinnovations.
BANNEDDRUGSUPDATES

Dextropropoxyphene and formulations for


humanuse.
Thedrugisusedtotreatmildpainandalsohaslocalanaesthetic
effects. The severe or irreversible adverse effects of
Dextropropoxyphene include sinus tachycardia, hypotension,
orthostatic hypotension, seizures, dependence, cholestasis,
psychosis, sinus bradycardia, syncope, decreased libido, biliary
obstruction, reports said. Dextropropoxyphene produces
potentiallylifethreateningeffectswhichincludeconvulsions
FDCofFlupenthixol+Melitracenforhumanuse.
Melitracen is not approved in India. This drug is made in
Denmark. However, it is not approved for use in Denmark itself.
Accordingtorule30Binthedrugsact.Anydrugnotapprovedin
the country of origin cannot be used in India. It's sale is
prohibitedintheUK,US,Canada,AustraliaandJapan,
Analginandallformulationsforhumanuse.
Analgin is a drug possessing analgesic and antipyretic effects.
Butitisusedwithhighcautioninpatientssufferingfromchronic
pulmonary infections and bronchial asthma. It is also known to
cause a steep decrease in the count of white blood cells, which
can lead to a potentially fatal state. The drug was thus taken off
the shelves in many countries including Sweden, Japan, France,
Australia,CanadaandNewZealand.
VEGETABLESCUTDOWNDIABETESRISK
A new study says, eating leafy vegetables like broccoli,
spinach,sproutsandcabbagecanreduceby14percentyourrisk
of developing Type 2 diabetes. The vegetables are a rich source
ofantioxidantsand magnesium,linkedtolowerlevelsof diabe
tes. Regularly sampling salads, including spinach could help
reducediabetesrisk,thestudyhasshown.
UniversityofLeicesterresearchersreviewedsixstudies
based on 223,000 people and compared intake of green leafy
vegetables. They found those who consumed more than one
servingdailyhadalowerriskofdiabetesthanpeoplewhobarely
AYURVEDAAPOSITIVEHOPEFORHIV+
PATIENTS
An ongoing study by the KEM Hospital, Mumbai, India to find out
the efficacy of ayurvedic drugs in improving the life expectancy of
HIVpositivepatientshasyieldedsomepositiveresults.Thehospi
talhasbeenstudyingthepotencyofanayurvedicdrugon700HIV
patientssinceAprillastyear.Theinstitutefoundasignificantboost
inthecountofCD4cellsinthesepatients,andthatitcould proba
blypushtheinitiationofAntiRetroviralTherapy(ART),knownto
have many side effects, by a few years. The count of CD4 cells is
directly proportional to the health of a person for these cells are
themostimportantpartofone'simmunesystem.TheARTforHIV
patientsisstartedonlyaftertheCD4countfallsbelow250.After
administering the ayurvedic drug, the doctors found that the CD4
countinpatientsonanaveragewentupfrom448to546withinsix
monthsandupto590inayear'stime.Besides,manypatientshad
weight gains, increase in haemoglobin count and a sense of well
being. However, the study solely focused on CD4 cells and did not
check if the drug could bring down the viral load in a patient.An
other hitch remains that ayurvedic drugs cannot be consumed si
multaneouslywiththeARTdrugs.Ref:AyurvedicDrugIndex
#5
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AURO Quiz
1.Whichofthefollowingisusedasananticravingagent
fortreatmentofalcoholdependence?
A.DisulfiramB.Acamprosate
C.MetronidazoleD.Alloftheabove
2. A 9year old child has increased horizontal anterior
bone loss, less cementum and on test shows excretion of
phosphoethanolamineintheurine.Thechildissuffering
from
A.HypophosphatasiaB.VitaminDresistantrickets
C.JuvenileperidonitisD.Osteomalacia
3. Identify this eminent physiologist who is credited for
findingfeedingcentreinhypothalamus.

AnswersonPage4
C h e c k Y o u r G C P K n o w l e d g e 1 . C 2 . B 3 . D
LATESTAMENDMENTSINSCHEDULEY
Recently there have been three amendments in Schedule Y of the
DrugsandCosmeticsAct.

The first gazette notification is G.S.R. 53 (E) dated January 30,


2013,withinsertionofRule122DABwhichspecifiesproceduresto
analyzethereportsofSAEsoccurringduringclinicaltrialsandpay
mentofcompensationincaseoftrialrelatedinjuryordeathasper
defined timelines. The detailed process is described by addition of
AppendixXIIinScheduleY.
The second gazette notification is G.S.R. 63(E) dated February
01,2013withinsertionofRule122DACwhichspecifiesconditions
under which application for conduct of clinical trials shall be ap
proved by licensing authority, which includes a very important
point that the sponsors, their subsidiaries, agents, subcontractors,
andclinicaltrialsitesshallallowinspectorsauthorizedbyCDSCOto
inspecttheirpremises.
The third amendment is related to mandatory registration of
theEthicsCommittees(EC)intheDrugandCosmeticactvideG.S.R.
72(E)datedFebruary08,2013withadditionofRule122DD.
Services of AHC: * Clinical Trial Management for New Chemical Entity,
ChemicalEntity,HerbalMedicines,Nutraceuticals,Cosmecuticalsetc,
*MedicalWritingandRegulatoryAffairs*PreclinicalServices
*DrugDiscovery,FormulationandDevelopmentServices
*ClinicalDataManagementandStatisticalAnalysis
Contactatmgr.bd@auroushealthcare.comorat+919551050612.
GCPGUIDELINEFORCLINICALTRIALSINASU(Ayurvedic,Siddha,Unani)MEDICINES

ThedepartmentofAYUSHhasissuedgoodclinicalpractice(GCP)guidelinesforclinicaltrialsinAyurveda,SiddhaandUnani
(ASU) medicines which will facilitate the researchers and institutions in adopting a standard way of good clinical practice
whileconductingtheASUclinicaltrials.Theguidelinesareaddressedtoinvestigatorsandallthose,whoareinterested,con
cerned, involved and affected with the conduct of clinical trials on ASU drugs. These are timely in view of the focus being
givenforscientificvalidationandforpromotingevidencebaseduseofASUtreatmentsandaremeantforvoluntaryuse,not
linkedwithanyprovisionsofDrugs&Cosmetics(D&C)Act,1940,andtherulesthereunder.ThefundamentaltenetofGCPis
thatinresearchonman,theinterestofscienceandsocietyshouldnevertakeprecedenceoverconsiderationsrelatedtothe
well being of the study subject. It aims to ensure that the studies are scientifically and ethically sound and that the clinical
propertiesoftheASUmedicineunderinvestigationareproperlydocumented.Theguidelinesseektoestablishtwocardinal
principles: protection of the rights of human subjects and authenticity of ASU medicine clinical trial data generated. They
should be followed for carrying out all ASU medicine research in India at all stages of drug development, whether prior or
subsequenttoproductregistrationinIndia.
Reference:http://indianmedicine.nic.in/writereaddata/linkimages/5110899178Final%20Book%20280313.pdf
#7
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AUROUS HEALTHCARE RESEARCH AND DEVELOPMENT INDIA PRIVATE LIMITED
(FormerlyAurovilleHealthCareR&DIndiaPvtLtd.)
#180/109,RangarajapuramMainRoad,Kodambakkam,Chennai600024.
Phone:+914423720600,+914432472446Mobile:+919551050612Fax:+914423720600
contact@auroushealthcare.commgr.bd@auroushealthcare.comwww.auroushealthcare.com

THEPIONEERCONTRACTRESEARCHORGANISATION(CRO)WITHFOCUSONCLINICALRESEARCH