From the Desk of MD……...
Aurous HealthCare—CRO 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 HealthCare—CRO 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 research—in particular—clinical 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 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 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
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.
WHO APPROVES INDIA’S DRUG
The World Health Organization has cleared India's
vaccine regulatory system for maintaining International
standards, paving the way for easy export of vaccines produced
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
conducted its comprehensive review in December last.
Mini Water Treatment………..…Page 4
India's Rs 19,000‐crore
vaccine industry accounts for
AURO Ayur……...…………...……… Page 4
exports worth 13 billion US
dollars to 150 countries. India is
AURO Byte……...…………...……… Page 5
a major vaccine producer that
USFDA - Medical Devices.……… Page 6
In 2012, India had seven
vaccine manufacturers producing 67 prequalified vaccines
(dosage forms). Currently 16 vaccines are prequalified by WHO
AURO Days……...…………...……… Page 6
and exported through United Nations agencies. More than
70 percent of all measles vaccines used globally are produced in
GCP for ASU Medicines.....……… Page 7
WHO assessment of a regulatory authority as
functional means the country's vaccine production lines are
AURO Quiz……...…………...……… Page 7
efficacious and safe and can easily be trusted. With a regulatory
system for vaccines assessed as functional by WHO, vaccine
manufacturers in India continue to remain eligible to apply for
prequalification of specific products.
which is a guarantee that a
specific vaccine meets
international standards of
in your INBOX !!!
quality, safety and effi‐
Send a test mail and receive quarterly up
cacy, is a prerequisite for
dates on Clinical Trials and Drug Research
in your inbox!
manufacturers to supply
to countries through
United Nations procuring
Ref: The Economic Times
MINIWATERTREATMENT PLANT IN A
Hindi: Chhotachand ,
Harkaichanda , Nai ,
Marathi: Harkaya ,
Karki , Mungusavel ,
English: Indian snake
root. Serpentine root
Chandrika, Nakuli, Sarpadani, Kukkudi, Raktatrika
Tamil: Patalagandhi , Patalagaruda , Sovannamilbori
Malayalam: Amalpori, Chuvanna amalpori
They call it a mini‐
w a t e r ‐ t r e a t m e n t
plant in a packet.
The powder essen‐
tially performs the
job of a municipal
but on a much
smaller and portable
The chemistry is
impressive, yet the
Central nervous system disorders associated with psychosis,
schizophrenia, insanity, insomnia, and epilepsy.
incredibly simple. It
Extracts of the roots are valued for the treatment of intestinal
involves pouring the
disorders, particularly diarrhea and dysentery and also as
contents of one
The juice of the leaves has been used as a remedy for opacity
weighs less than an
of the cornea.
ounce, into a bucket of 10 quarts of water and stirring.
Dirt, parasites and other material drop to the bottom, and
Overdose cause giddiness and is toxic.
disease‐causing microbes die.
Ref :Odhisha Forest Development Corporation
To meet the program goal of saving one life every hour by
2020, P&G has established a three‐pronged strategy, with one
step already complete. In November 2012, they finished build‐
ing a new facility in Singapore to ramp up production of the
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
Clinical Trial Management Services from 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 : firstname.lastname@example.org or at +919551050612
AuroQuiz answers: 1.B 2.A. 3. Dr. Bal Krishnan Anand
BANNED DRUGS UPDATES …
VEGETABLES CUT DOWN DIABETES RISK…
A new study says, eating leafy vegetables like broccoli,
spinach, sprouts and cabbage can reduce by 14 percent your risk
of developing Type 2 diabetes. The vegetables are a rich source
of anti‐oxidants and magnesium, linked to lower levels of diabe‐
tes. Regularly sampling salads, including spinach could help
reduce diabetes risk, the study has shown.
University of Leicester researchers reviewed six studies
based on 223,000 people and compared intake of green leafy
vegetables. They found those who consumed more than one
serving daily had a lower risk of diabetes than people who barely
Dextropropoxyphene and formulations for
AYURVEDA A POSITIVE HOPE FOR HIV+
The drug is used to treat mild pain and also has local anaesthetic
effects. The severe or irreversible adverse effects of
An ongoing study by the KEM Hospital, Mumbai, India to find out
Dextropropoxyphene include sinus tachycardia, hypotension,
the efficacy of ayurvedic drugs in improving the life expectancy of
orthostatic hypotension, seizures, dependence, cholestasis,
psychosis, sinus bradycardia, syncope, decreased libido, biliary HIV positive patients has yielded some positive results. The hospi‐
tal has been studying the potency of an ayurvedic drug on 700 HIV
obstruction, reports said. Dextropropoxyphene produces
patients since April last year. The institute found a significant boost
potentially life‐threatening effects which include convulsions
in the count of CD4 cells in these patients, and that it could proba‐
bly push the initiation of Anti‐Retroviral Therapy (ART), known to
Melitracen is not approved in India. This drug is made in
Denmark. However, it is not approved for use in Denmark itself. have many side effects, by a few years. The count of CD4 cells is
According to rule 30 B in the drugs act. Any drug not approved in directly proportional to the health of a person for these cells are
the most important part of one's immune system. The ART for HIV
the country of origin cannot be used in India. It's sale is
prohibited in the UK, US, Canada, Australia and Japan,
patients is started only after the CD4 count falls below 250. After
administering the ayurvedic drug, the doctors found that the CD4
Analgin and all formulations for human use.
Analgin is a drug possessing analgesic and anti‐pyretic effects. count in patients on an average went up from 448 to 546 within six
But it is used with high caution in patients suffering from chronic months and up to 590 in a year's time. Besides, many patients had
pulmonary infections and bronchial asthma. It is also known to weight gains, increase in haemoglobin count and a sense of well‐
cause a steep decrease in the count of white blood cells, which being. However, the study solely focused on CD4 cells and did not
can lead to a potentially fatal state. The drug was thus taken off check if the drug could bring down the viral load in a patient. An‐
the shelves in many countries including Sweden, Japan, France, other hitch remains that ayurvedic drugs cannot be consumed si‐
FDC of Flupenthixol+Melitracen for human use.
Australia, Canada and New Zealand.
multaneously with the ART drugs. Ref: Ayurvedic Drug Index
Foldit is an online puzzle video game about protein folding. The game is
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 "real‐world"
problems, by targeting and eradicating diseases, and creating biological innovations.
LATEST AMENDMENTS IN SCHEDULE Y…
1. Which of the following is used as an anticraving agent
for treatment of alcohol dependence?
A. Disulfiram B. Acamprosate
C. Metronidazole D. All of the above
2. A 9year old child has increased horizontal anterior
bone loss, less cementum and on test shows excretion of
phosphoethanolamine in the urine. The child is suffering
A. Hypophosphatasia B. Vitamin D resistant rickets
C. Juvenile peridonitis D. Osteomalacia
3. Identify this eminent physiologist who is credited for
finding feeding centre in hypothalamus.
Recently there have been three amendments in Schedule Y of the
Drugs and Cosmetics Act.
The first gazette notification is G.S.R. 53 (E) dated January 30,
2013, with insertion of Rule 122 DAB which specifies procedures to
analyze the reports of SAEs occurring during clinical trials and pay‐
ment of compensation in case of trial related injury or death as per
defined timelines. The detailed process is described by addition of
Appendix XII in Schedule Y.
The second gazette notification is G.S.R. 63(E) dated February
01, 2013 with insertion of Rule 122 DAC which specifies conditions
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, sub‐contractors,
and clinical trial sites shall allow inspectors authorized by CDSCO to
inspect their premises.
The third amendment is related to mandatory registration of
the Ethics Committees (EC) in the Drug and Cosmetic act vide G.S.R.
72(E) dated February 08, 2013 with addition of Rule 122 DD.
Answers on Page 4
GCP GUIDELINE FOR CLINICAL TRIALS IN ASU (Ayurvedic, Siddha, Unani) MEDICINES…
The department of AYUSH has issued good clinical practice (GCP) guidelines for clinical trials in Ayurveda, Siddha and Unani
(ASU) medicines which will facilitate the researchers and institutions in adopting a standard way of good clinical practice
while conducting the ASU clinicaltrials. The guidelines are addressed to investigators and all those, who are interested, con‐
cerned, involved and affected with the conduct of clinical trials on ASU drugs. These are timely in view of the focus being
given for scientific validation and for promoting evidence‐based use of ASU treatments and are meant for voluntary use, not
linked with any provisions of Drugs & Cosmetics (D&C) Act, 1940, and the rules there under. The fundamental tenet of GCP is
that in research on man, the interest of science and society should never take precedence over considerations related to the
well being of the study subject. It aims to ensure that the studies are scientifically and ethically sound and that the clinical
properties of the ASU medicine under investigation are properly documented. The guidelines seek to establish two cardinal
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
subsequent to product registration in India.
Services of AHC:
* Clinical Trial Management for New Chemical Entity,
Chemical Entity, Herbal Medicines, Nutraceuticals, Cosmecuticals etc,
*Medical Writing and Regulatory Affairs *Preclinical Services
* Drug Discovery , Formulation and Development Services
*Clinical Data Management and Statistical Analysis
Check Your GCP Knowledge 1.C 2.B 3. D
Contact at email@example.com or at +919551050612.
THE PIONEER CONTRACT RESEARCH ORGANISATION (CRO) WITH FOCUS ON CLINICAL RESEARCH
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
firstname.lastname@example.org email@example.com www.auroushealthcare.com