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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 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 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
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
WHO APPROVES INDIA’S DRUG REGULATORY SYSTEM... 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.
India's Rs 19,000‐crore vaccine industry accounts for exports worth 13 billion US dollars to 150 countries. India is a major vaccine producer that
has 12 major vaccine manufacturing facilities. In 2012, India had seven
vaccine manufacturers producing 67 prequalified vaccines
(dosage forms). Currently 16 vaccines are prequalified by WHO and exported through United Nations agencies. More than 70 percent of all measles vaccines used globally are produced in India.
WHO assessment of a regulatory authority as functional means the country's vaccine production lines are 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. WHO prequalification, which is a guarantee that a
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: The Economic Times
AurouSpeak in your INBOX !!!
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#3
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AURO Ayur… Rauvolfia Serpentina
Hindi: Chhotachand , Harkaichanda , Nai , Nakulikanda
Marathi: Harkaya , Karki , Mungusavel , Sapasanda English: Indian snake
root. Serpentine root Sanskrit: Sarpagandha, Chandrika, Nakuli, Sarpadani, Kukkudi, Raktatrika Tamil: Patalagandhi , Patalagaruda , Sovannamilbori
Malayalam: Amalpori, Chuvanna amalpori Medicinal uses:
Central nervous system disorders associated with psychosis, schizophrenia, insanity, insomnia, and epilepsy.
Extracts of the roots are valued for the treatment of intestinal disorders, particularly diarrhea and dysentery and also as anathematic.
The juice of the leaves has been used as a remedy for opacity of the cornea.
Side effects:
Overdose cause giddiness and is toxic. Ref :Odhisha Forest Development Corporation
MINIWATERTREATMENT PLANT IN A
PACKET …
They call it a mini‐
water ‐ t rea tment plant in a packet. The powder essen‐tially performs the
job of a municipal treatment facility but on a much smaller and portable
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, parasites and other material drop to the bottom, and disease‐causing microbes die.
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
water‐purifier packets. 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
drinking water.
AuroQuiz answers: 1.B 2.A. 3. Dr. Bal Krishnan Anand
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 : [email protected] or at +919551050612
#4
AurouSpeak
www.auroushealthcare.com
AURO Byte… www.fold.it 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.
BANNED DRUGS UPDATES …
Dextropropoxyphene and formulations for
human use. The drug is used to treat mild pain and also has local anaesthetic
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
potentially life‐threatening effects which include convulsions
FDC of Flupenthixol+Melitracen for human use. Melitracen is not approved in India. This drug is made in
Denmark. However, it is not approved for use in Denmark itself.
According to rule 30 B in the drugs act. Any drug not approved in the country of origin cannot be used in India. It's sale is
prohibited in the UK, US, Canada, Australia and Japan,
Analgin and all formulations for human use. Analgin is a drug possessing analgesic and anti‐pyretic effects. But it is used with high caution in patients suffering from chronic
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, Canada and New Zealand.
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
AYURVEDA A POSITIVE HOPE FOR HIV+ PATIENTS… An ongoing study by the KEM Hospital, Mumbai, India to find out
the efficacy of ayurvedic drugs in improving the life expectancy of
HIV positive patients has yielded some positive results. The hospi‐
tal has been studying the potency of an ayurvedic drug on 700 HIV
patients since April last year. The institute found a significant boost
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
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
the most important part of one's immune system. The ART for HIV
patients is started only after the CD4 count falls below 250. After
administering the ayurvedic drug, the doctors found that the CD4
count in patients on an average went up from 448 to 546 within six
months and up to 590 in a year's time. Besides, many patients had
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‐
multaneously with the ART drugs. Ref: Ayurvedic Drug Index
#5
AurouSpeak
www.auroushealthcare.com
AURO Quiz… 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
from 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.
Answers on Page 4
Check Your GCP Knowledge 1.C 2.B 3. D LATEST AMENDMENTS IN SCHEDULE Y… 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.
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
Contact at [email protected] or at +919551050612.
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. Reference: http://indianmedicine.nic.in/writereaddata/linkimages/5110899178Final%20Book%20280313.pdf
#7
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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 [email protected] [email protected] www.auroushealthcare.com
THE PIONEER CONTRACT RESEARCH ORGANISATION (CRO) WITH FOCUS ON CLINICAL RESEARCH