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VOL.2, NO.

3 OF MARCH, 2009

Vol. 2, No. 3 of

March
NetRUM 2009
Newsletter ©

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VOL.2, NO.3 OF MARCH, 2009

GROUP OWNER:
Dr. Vijay Thawani
NetRUM is a not-for-profit, voluntary, co-operative, non-funded, E- Associate Professor
discussion group of like-minded rationalists without any conflict of Dept. of Pharmacology,
interest. It is three years young and has >415 members globally. Govt. Medical College,
NetRUM was born on March 16, 2006 during the training course on Nagpur – 440 003, India
promoting rational use of medicines held in collaboration with WHO's vijaythawani@rediffmail.com
EDOM, SEARO. NetRUM continuously conducts E-discussions on hot NEWSLETTER EDITOR:
topics, which are facilitated by knowledgeable moderators who offer Dr. Geer M. Ishaq
their valuable, expert and free services. About 200-300 messages are Assistant Professor,
posted on NetRUM every month. So far NetRUM has conducted 99 Dept. of Pharmaceutical Sciences
discussions moderated by 30 moderators. For more details please visit University of Kashmir
our group: Srinagar, J&K, India
EDITORIAL COORDINATOR:
http://health.groups.yahoo.com/group/netrum/ Dr. Smita Mali
Senior Resident in Pharmacology,
Govt. Medical College,
Nagpur – 440 003, India

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VOL.2, NO.3 OF MARCH, 2009

IN THIS ISSUE
CONTENTS PAGE NO.
List of discussions held during February, 2009 04
Summary of the discussion “Good governance in health sector” 05
Summary of the discussion “Traditional medicine: panacea or poison?” 09
Summary of the discussion “Pharmacovigilance of Ayurvedic medicines” 13
News briefs relating to Rational Use of Medicines 16
Details of over 100 discussions held over NetRUM so far 21
Schedule of Forthcoming NetRUM discussions 31

ATTENTION PLEASE:
NETRUM IS CELEBRATING
CENTURY OF E-DISCUSSIONS.
PLEASE MAKE SURE THAT YOU
AS ITS ACTIVE MEMBER MAKE
A POSTING IN THE
CELEBRATIONS. HAPPY
NETWORKING

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VOL.2, NO.3 OF MARCH, 2009

DISCUSSIONS HELD DURING FEBRUARY 2009


1. Good governance in health sector
Period of Discussion: 05 - 10 Feb., 2009
Name of Moderator: Dr. M. Bashaar

2. Traditional medicine: panacea or


poison?
Period of Discussion: 12 - 17 Feb., 2009
Name of Moderator: Dr. Ghalib

3. Adherence to STG for asthma in the


community
Period of Discussion: 19 - 24 Feb., 2009

Name of Moderator: Dr. Anita Kotwani

4. Pharmacovigilace of ayurvedic
medicines
Period of Discussion: 26 – 31 Feb., 2009
Name of Moderator: Dr. Anand Chaudhary

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VOL.2, NO.3 OF MARCH, 2009

ABOUT THE MODERATOR “Good governance in


health sector”
Good governance in health generally translated into public health practice for
Dr. Mohammad Bashaar graduated refers to the enhancement of the the betterment of the population.
from Kabul Medical University with Governance means decision-making
stewardship functions and the
major in Curative Medicine and obtained and the implementation of decisions.
improvement of management support
his Masters degree in Health Management These decisions can be made within all
systems of government in terms of its
from Preston University. At present he is
responsibility for the overall different kinds of social institutions and
working for United Nations Development
performance of the health system. arrangements and relate to
Programme in Afghanistan besides
Good governance stands for the aim of communities, corporations, national
serving as a lecturer in Karwan Medical
Institute Kabul, Afghanistan. Dr. Bashaar bringing together administrative bodies and international levels. Good
has participated in many national and and all relevant stakeholders (citizens, governance is a concept articulated
international events; his last visit to India NGOs, industry, etc) to implement and conceptualized in the context of
being in April, 2008 when he presented a reforms improving the living conditions development and development aid. It
paper on the Health Status of Afghanistan for all people. was influentially formulated by the
post 9/11 at The Jawaharlal Nehru United Nations Economic and Social
University, New Delhi. Dr Bashaar is a The concept of good governance is Commission for Asia and the Pacific
medical activist with dynamism and (UNESCAP). Good governance was
increasingly being discussed in the
determination, vision and voice which
context of public health. This article meant to ensure that developing
can be heard. He has relentlessly been
explains what exactly is meant by this countries are free from oppression and
trying to assist in repair of the health
buzzword, how good governance can corruption and thus can prosper in
system of his war ravaged motherland.
be justified and how it can be wealth and health.

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CHARACTERISTICS OF GOOD laws requires an independent judiciary Acceptability and (d) Quality (e)
GOVERNANCE and an impartial and incorruptible Adequate sanitation
police force. Health is a fundamental
Good governance has eight major human right, indispensable for the full Transparency
characteristics. It is participatory, enjoyment of other human rights.
consensus-oriented, accountable, Transparency means that information
transparent, responsive, effective and is freely available and directly
efficient, equitable and inclusive and accessible to those who will be
follows the rule of law. affected by such decisions and their
enforcement. According to
Participation Transparency International,
transparency is “a principle that allows
Participation by men as well as women those affected by administrative
is the cornerstone of good governance. decisions, business transactions or
Participation could be either direct or charitable work to know not only the
through legitimate intermediate basic facts and figures but also the
institutions or representatives, such as Every human being is entitled to the mechanisms and processes. It is the
parliamentary and provincial council enjoyment of the highest attainable duty of civil servants, managers and
elections. standard of health conducive to living a trustees to act visibly, predictably and
life in dignity. The right to health in all understandably.”
Rule of law its forms and at all levels contains the
following interrelated and essential Responsiveness
Good governance requires fair legal elements, the precise application of
frameworks that are enforced which will depend on the conditions Good governance requires that
impartially. It also requires full prevailing in a particular State party: institutions and processes must try to
protection of human rights (a) Availability, (b) Accessibility, (c) serve all stakeholders within a
countrywide. Impartial enforcement of reasonable timeframe. Here everyone

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VOL.2, NO.3 OF MARCH, 2009

who is working in health sector (from from the mainstream of society. This who will be affected by its decisions or
gatekeeper to health minister) has the requires all groups, particularly the actions. Accountability cannot be
prime responsibility to perform the most vulnerable, to have equal enforced without transparency and the
duties with honesty and dedication. opportunities to maintain and improve rule of law.
their well being.
Consensus oriented Main regimes involved in good
Effectiveness and efficiency governance
Good governance requires mediation
of different interests in society to reach Good governance means that There are three main regimes involved
in good governance. They are the
a broad consensus in society on what processes and institutions produce
State, the Civil Society and the
is in the best interests of the whole results that meet the needs of society Private Sector. All three are critical for
community and how this can be while making the best use of resources sustaining human development. Since
achieved. All men and women should at their disposal. The concept of each one has its weaknesses and
have a voice in decision making for efficiency in the context of good strengths, a major objective of good
health, either directly or through governance also covers the governance is to promote highest
legitimate intermediate institutions that sustainable use of natural resources possible constructive interaction
among the three in order to minimize
represent their interests. Such broad and the protection of the environment.
individual weaknesses and utilize the
participation is built on freedom of strengths optimally.
association and speech, as well as Accountability According to Dr. Vijay Thawani, “If the
capacities to participate constructively. power really rested with people,
Accountability is a key requirement of governance of others will not be
Equity and inclusiveness good governance. Not only needed. It is only that the populations
governmental institutions but also the are not empowered and therefore are
A society’s well being depends on private sector and civil society not self-sufficient; they look at
governance from others. The very fact
ensuring that all its members have the organizations must be accountable to
that some govern; there are others
sense of involvement as stakeholder in the public. In general an organization who are governed by them. Hence in
it so that they do not feel excluded or an institution is accountable to those terms of health empowerment, the

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VOL.2, NO.3 OF MARCH, 2009

word governance is not in good taste. Corruption in the healthcare sector is a different strategies for its
Because it concentrates on concern for all countries, but it is implementation. In order to ensure
governance, it can never be good! No especially a critical problem in good governance in health, it is
governance in the world has ever been developing and transitional economies imperative to implement all those
good, so how can governance in health where public resources are already strategies which are quite basic. The
be?” Sh. Ram Charitra Sah from Nepal scarce. Corruption reduces the execution of good governance
feels, “Good governance is required for resources available for health, lowers strategies and practices is not only the
all and it is not only the business of the quality, equity and effectiveness of responsibility of the state or
civil society. It is preferable to use the healthcare services, decreases the government, but it is also the job of
word Society rather than Civil Society, volume and increases the cost of civil society and private sector and
considering most part of the society provided services. both of them should be equally
mostly comprises of civilized people”. accountable to the government.
As per Dr. Geer M. Ishaq, “Lack of Embezzlement in health sector
robust, comprehensive and region ACKNOWLEDGEMENT
specific health and medicine policies at Embezzlement is defined as the My warm gratitude goes to Dr. Vijay
national, state, district and hospital misappropriation of property or funds Thawani, who not only participated in
level in most of the economically legally entrusted to someone in their the discussion but provided all of us an
developing and under developed formal position as an agent or opportunity to work together to
countries is a major impediment in guardian. Everyone wants to believe promote good governance for health
effective health administration”. It is that the people they hire are good as well as Rational Use of Medicines. I
very true that robust and employees who can be trusted to am also very thankful to Dr. Smita Mali,
comprehensive health and perform their responsibilities with who invited me for the discussion and
pharmaceutical policies are essential integrity. obliged to Dr. Anupama Sukhlecha, Dr.
at all levels of the nation in order to Conclusion Geer M. Ishaq, Elizabeth Ominde-
ensure good health administration and Ogaja, 'Ranti Opanuga, and Ram
governance. Good governance does not merely Charitra Sah for their active
stand for effective management in the participation and valuable ideas.
Corruption in the health sector health sector. It is a broadly used term, - Dr. Mohammad Bashaar
but new in health sector, which needs
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VOL.2, NO.3 OF MARCH, 2009

ABOUT THE MODERATOR


“Traditional Medicine: Panacea
or Poison?”
Maintaining positive state of health and other metals / minerals) became an
freedom from diseases are the integral part of Ayurveda. The long
fundamental objectives of Ayurveda. history of usage of metallic
To achieve these, ancient seers of preparations in varied pathological
Ayurveda tried a number of laudable manifestations is enough proof for their
Dr. Galib is working as Lecturer measures and found that the resources safe, effective and nontoxic beneficial
at the Dept. of Rasa Shastra of different origin (Herbal / Animal / effects.
(Ayurvedic Pharmaceutics), Mineral / Marine etc) are most suitable
to accomplish the goals. Hence these In the recent years, use of Ayurvedic
Institute for Post Graduate medicines, particularly of herbal origin
Teaching & Research in Ayurveda, resources were converted into four
has increased substantially world over.
Gujarat Ayurved University, types of formulations viz. Herbal,
The greater usage has resulted in
Jamnagar, Gujarat. He has Herbo-Mineral, Mineral and Metallic, to
number of problems like increased
completed his graduation from which a vast range of therapeutic
properties have been attributed. The commercialization, pressure on
BRKR Govt. Ayurvedic College, harvesting, adoption of short cuts,
Hyderabad, Andhra Pradesh, science touched its new dimensions
after having been incorporated with the adulteration, development of
followed by MD (Ayurveda) from formulations without conceptual basis
National Institute of Ayurveda, knowledge of Rasaushadhies (pure
of Ayurvedic scriptures, incorrect use
Jaipur. Dr. Galib has more than 50 metallic and mineral preparations) from
by consumers and quacks, lack of
publications to his credit. 8th A.D. onwards. Since then the
metals and minerals have been used awareness of practitioners about
pharmacovigilance of Ayurvedic
abundantly in many dosage forms and
Rasa Shastra (the science dealing with formulations and free communication
different processes of mercury and across borders etc. In addition to this,

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a few of the western scientists raised respiratory congestion. In the United of Ayurveda considered in great detail
unfounded concern about safety and States, this herb was marketed as a the possible ways by which untoward
toxicity of these time tested dietary supplement, available OTC, effects can occur and provided all
formulations. Particularly the whose over dosing led to about dozen necessary guidelines to avoid the
Rasaushadhies [Metallic / Mineral deaths, heart attacks and strokes. occurrence of such effects. They
Preparations] have been repeatedly Hence the mute question whether the preferred on exercising great caution
targeted by western scientists, which system is wrong or the drug is while administering drugs for
have affected the reputation of poisonous? We feel the attitude therapeutic purposes. “Primum non
traditional Ayurvedic heritage. towards the drug is wrong. Though the nocere” meaning "first do no harm"
Ayurvedic medicines sold over internet drugs are traditional in origin, they was preached and practiced both while
have been reported to have high levels should always be used with proper approving new drugs, as well as
of heavy metal concentrations. After care and under qualified supervision. prescribing the established ones to
such reports, obviously the present WHO Guidelines 2004 clearly state patients. It implies that, there is a
generation became apprehensive that the drugs if improperly processed chance of getting ADRs with utilization
about the quality standards and safety and if used injudiciously may tend to of classical drugs, if prepared in an
of the metallic compounds and some of cause certain inconveniencies. inappropriate manner or if
the NetRUMians also raised queries administered injudiciously. Hence the
regarding these aspects during E- The metallic/mineral preparations have Gurus prescribed different processing
discussions. occupied coveted position in Ayurvedic techniques to remove the hazardous
pharmacopoeia and have been ingredients or properties, if any, from
Unregulated, injudicious and routinely used in India since centuries. these. They also prescribed testing
inappropriate use of Ayurvedic The Ayurvedic literature says that
methods for the prepared products,
medicines and practices definitely these preparations will be safe,
which will tell the manufacturer
leads to the causation of negative or efficacious even at minute doses and
whether the drug has attained the form
dangerous effects. For instance, the never develop any significant untoward
that does not have hazardous
herb “Ma Huang” (Ephedra) is effects if manufactured in accordance properties when used properly by a
traditionally used in China to treat with specified guidelines. The founders physician.

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The accusation that Ayurvedic drugs in detoxifying the material and making concentrations. This needs the
are toxic because they contain heavy them potent and suitable for techniques suitable for separation and
metals is based on ignorance. We therapeutic application. Reputed identification of the various bio-
agree that to say that Ayurvedic drugs teaching institutions like Gujrat molecules bound to these metals as
are safe because they have been used Ayurved University, Banaras Hindu well as methods to estimate their
since thousands of years, is also not University have focused research on concentrations. The emerging area of
very scientific. If any ADR or adverse metals and minerals like mercury, lead, proteomics and metallomics aims at
events develop, it is due to the poor arsenic and herbo-mineral /metallic providing information to enable better
product quality or improper use. Weak preparations to screen through understanding of the mechanism by
quality control systems and inadequate relevant analytical and which these preparations exhibit
regulatory measures contribute to it. To pharmacological parameters. Most of therapeutic effects. Additionally there is
promote and improve the quality, and the studies confirmed that the need to carry out biochemical
to reduce the proportion of ADR metals/minerals when converted into estimation of anti-oxidants which are
attributable to poor quality, WHO GMP the medicines by strictly following the responsible for the protection of cells
updated guidelines for herbals and advocated classical guidelines of with respect to free radical induced
updated core guidelines on GMP need ancient texts, were devoid of toxicity damages. It is possible that the
to be followed. even at the levels of 100 TEDs. The therapeutic efficacy of certain
histopathological studies on different Ayurvedic drugs could be through the
To revalidate the safety and efficacy of visceral organs also did not reveal any production of anti-oxidants.
age old remedies, many scientific apparent pathological damage with use
studies have been conducted at of these. It is well known that the exposure to
various post graduate institutions heavy metals is countered by the in-
throughout India, which prove the In-vivo condition many preparations situ synthesis of phyto-chelatins in
necessity and significance of the containing metals bind with peptides or plants and metallothionines in animals.
sanskaras (specific guidelines to be other functional groups. It is essential Such investigations in humans are
mandatorily followed while dealing with to identify these molecules that bind to needed to determine the mode of
metals, minerals or other toxic drugs) the metals, as well as their action of the metallic preparations. In

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order to instill confidence in the  Comprehensive database to discussion. Acknowledgements are


medical community, it is imperative to substantiate the actual efficacy and due to the constant backup provided
carry out bio-chemical studies to safety on all the metals/minerals. by Dr Vijay Thawani.
understand the action of Ayurvedic  Implementing stringent quality
drugs at the molecular level. It is felt control methods. - Dr Galib
that:
To revalidate the actual safety and
 Skepticism should not be there
efficacy, stratified clinical trials can be
about use of the metals/minerals. initiated to confirm the efficacy, provide
To achieve this, there is need to accuracy and confirm the safety in a
provide scientific basis to the use of scientific manner. Govt. of India
use of TM. through GTP, where AYUSH, CSIR
 Bio-chemical basis to the Ayurvedic and ICMR are the active partners, is
formulations needs to be developed
doing exclusive work on metallic,
to answer the scientific questions
herbo-mineral compound formulations.
like what are the new bio-molecules
We hope that in near future the results
synthesized in the body on the
of these studies will be a boon to the
consumption of these medicines; Ayurveda. A comprehensive database
which are the body tissues that covering all these findings will definitely
accumulate these metals and in provide a substantial answer to the
what molecular form; the relation concerns raised by the western
between the dose and the mode of
scientists on safety and efficacy of
excretion.
metals and minerals.
 Cell line studies are essential to
find out the actual
pharmacokinetics and dynamics of I acknowledge kind participation of all
the metallic/mineral preparations. members of the NetRUM in this

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ABOUT THE MODERATOR


“Pharmacovigilance of Ayurvedic
Medicines”
Pharmacovigilance (PV) is a science programme for medicines of Ayurvedic,
concerned with activities relating to the Sidha and Unani (ASU) systems.
detection, assessment, understanding Subsequent upon receiving reports of
and prevention of adverse effects or many adverse drug reactions (ADRs)
any other possible drug related of medicines belonging to these
Dr Anand Chaudhary is
problems. Specific goals of PV are: systems, there has been a constant
Associate Professor in Rasa
surge in the demand to address this
Shastra (Ayurvedic 1- Improve patient care and safety in
specific issue with reliable and genuine
Pharmaceutics), Faculty of relation to use of medicines and
expertise. Consequent upon insistence
Ayurveda, Institute of Medical other interventions.
by the WHO, Dept. of AYUSH, Ministry
Sciences, Banaras Hindu 2- Improve public health and safety in
of Health & Family Welfare, Govt of
University, Varanasi. He did his relation to the use of medicines.
India started substantial steps for
graduation from Allahabad 3- Contribute to the assessment of
planning and execution of a
University in 1986; BAMS from benefit, harm, effectiveness and
risk of medicines, encouraging their comprehensive PV programme for
the University of Kanpur in
safe, rational and more effective ASU medicines. After a series of
1993, followed by MD in 1997
(including cost effective) use. consultations and draft meetings, this
and PhD in 2002 from BHU. His
programme was launched for ASU
areas of interest include 4- Promote understanding, education
and clinical training in medicines on 29th September, 2008 by
Ayurvedic Pharmaceutics of
the then Commissioner-Secretary,
herbals, Stability profile of pharmacovigilance and its effective
Health & FW, Ms. Anita Das with
Ayurvedic medicines and communication to the public.
establishment of National
regulatory affairs. He has 68
Pharmacovigilance Centre for ASU
publications to his credit. The discussion focused upon origin
Drugs at Institute of Post Graduate
and implementation of the PV

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Teaching and Research in Ayurveda, should be considered before their nourished and nurtured the human
Gujarat Ayurveda University, administration into the patients for civilizations for centuries. In India,
Jamnagar. Later this centre identified proper therapeutic effects. Any British imposed a legal ban in 1835 on
eight regional centers and thirty deviation from these standard the practice of these systems of
peripheral centers all over the country. operating procedures leads to many medicine and opened medical colleges
ADRs. This has been specifically in English system of medicine
It is pertinent to ponder whether these emphasized in the description of throughout the country. There were
centers will adopt the same Charak Samhita, Sutra Sthana, comments that since aspirin interacts
methodology for ASU as followed for Chapter 1, Verse No. 126 which with herbs, we should dump all
allopathic medicines or develop a means, “Even an acute poison can Ayurvedic medicines in Indian Ocean
separate specific protocol for ASU become an excellent medicine if it is and in view of the reports of lead
systems. Experts of ASU systems properly administered; on the other poisoning with some ASU medicines,
visualized that the concept of safety hand, a potent medicine can prove to Ayurveda must be banned all over the
and precautions specified for these be an acute poison if administered globe. They conveniently forgot the
systems for their manufacture and improperly.” In light of this, the present endless reports of morbidity and ever
administration are in tandem with the discussion was taken up in which increasing ADRs due to new and old
aims and objectives of PV. Although members raised their apprehensions synthetic molecules in the allopathic
exact term for PV in Sanskrit language and doubts about drug interactions, system of medicine.
does not figure in Ayurvedic texts, the drug herb interactions, problem of
spirit of PV is vibrant in the scriptures multi-constituent formulations, their Being a student of Ayurvedic
and is emphasized repeatedly in all manufacturing procedures and other pharmaceutics, I salute our ancestors
major samhitas viz. Charak Samhita, aspects which were mostly due to lack for discovering more than 123 dosage
Sushruta Samhita and Astang Hridaya of awareness about ASU medicines. forms out of which at present we are
to name a few. Acharya Charak practicing not more than 35
narrated several factors about Before giving misleading facts about formulations. Their wisdom and
medicines right from harvesting, the science of life, it has to be kept in farsightedness is evident from the fact
procurement, preparation etc which mind that ASU systems have that even before the terms like

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VOL.2, NO.3 OF MARCH, 2009

galenicals or pharmaceutics came into to understand such disinformation and Members are requested to be assured
being, Ayurvedic and Unani have the ability to differentiate between about the safety and efficacy of
procedures were invented by them. the correct and wrong arguments Ayurvedic medicines. However GMP
One of the NetRUMian suggested about ASU medicines. However should be in place and necessary
some good terms like Ayurgenomics, shortcomings do exist in every growing quality control for the validation of
Herboprint and digitalization of science which need to be overcome these medicines should be taken up on
knowledge vide Ayusoft, Rudra etc. and same holds true ASU. It is priority basis. The PV of ASU
We welcome these suggestions with necessary that these need to be medicines with a positive frame of
full sincerity and one may be pleased improved to ensure globalized mind has just started and like any other
to know that CSIR has done wonderful acceptance of our indigenous systems new approach, is suffering from
job on such aspects. I express my of medicine. teething problems, which will certainly
heartfelt indebtedness to those vanish as we grow up. In the end, I
pioneers who invested their precious While we adopt latest technology in humbly convey my deep sense of
time to study medicines belonging to every walk of our life, we need to apply gratitude to all members of NetRUM for
ASU systems and produced the the basic principles of core sciences to providing their constructive and critical
valuable works before the world with develop suitable technologies for the suggestions on this issue. Prof Vijay
concrete evidence. advancement of these systems of Thawani deserves a special mention
medicine so that without compromising for encouraging me to take
I request all learned members of on the fundamentals, we may be able responsibilities of the moderator in
NetRUM to have a look on the findings to develop such dosage forms of ASU spite of some hindering odds. My
of SASTRA, Thanjavur and notification that are free from ADRs. Further it affectionate appreciations for Prof Vijay
of Govt of India dated Sept 3rd , 2009 needs to be ascertained whether Thawani and his team are also due for
on these issues, most important being reported ADRs are produced by all the painstaking work at NetRUM,
the statement of Robert Saper from genuine ASU medicines or by other especially to our young editor Dr Geer
Boston, during the convention of IPA at spurious, adulterated and misbranded M. Ishaq for his dedicated hard work.
New Delhi in Dec 2008. We have products. - Dr. Anand Chaudhary
enough education, power and insight

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VOL.2, NO.3 OF MARCH, 2009

News Briefs Relating to Rational Use of Medicines


export goes up by 28% exports contributed only 4.1 per cent to
in April-Dec 2008 Indian pharma exports. (Pharmabiz dt.
Health ministry to add April 13th, 2009)
Schedule Y1 to D&C Rules to Mumbai: Pharmaceutical exports from
India increased by 28.1 per cent during Report warns of
streamline clinical trials
the first nine months ended December
sector problems with
2008 to Rs 36,878 crore from Rs
28,786 crore in the corresponding
multivitamins
New Delhi: The Health Ministry is
planning to incorporate a new schedule period of last year. As per the NEW YORK - More than 30 percent of
'Y1' to the Drugs and Cosmetic Rules Pharmaceuticals Export Promotion multivitamins tested recently by
1945, to specify all rules regarding Council (Pharmexcil) the exports in ConsumerLab.com contained
clinical trials including guidelines for December 2008 went up sharply by
significantly more or less of an
registration of trials, penalty provisions 80.4 per cent to Rs 4,934 crore from Rs
ingredient than claimed, or were
for defaults, registration of ethics 2,735 crore. The exports to top 25 contaminated with lead, the company
committees and on-site audits of trials. countries contributed over 66 per cent reports. Several multivitamin products
The draft guidelines on trials and at Rs 24,389 crore as against 52 per tested, including three for children,
requirements for registration of clinical cent to Rs 19,183 crore. In dollar exceeded tolerable upper limits
research organisations, prepared by an terms, the exports have recorded 21
established by the Institute of Medicine
expert panel, and proposed amendment per cent growth from $6.98 billion to for ingredients such as vitamin A, folic
in rules have already been approved by $8.45 billion. Despite economic acid, niacin and zinc, according to the
the Drug Technical Advisory Board slowdown and stiff competition, the report posted on
(DTAB) and the DCC, and are waiting to exports during the first nine months of www.ConsumerLab.com. For example,
be notified. After the approval of the 2008-09 in the US moved up by 23.1
the Institute of Medicine sets a
minutes of the last DTAB meeting, the per cent to Rs 6,657 crore from Rs
recommended daily allowance (RDA) of
guidelines are likely to be announced, 5,409 crore in the same period of last 1,300 international units (IU) of
sources said. It is also proposed to year. The exports to US worked out to vitamin A for children ages 4 to 8 years
incorporate Rule 122DAB for the 18.1 per cent of the total exports.
and an upper tolerable limit of 3,000
proposed new Schedule Y1, it is learnt. Russia stood second largest destination IU. However, one multivitamin tested
(Pharmabiz dt. April 13th, 2009) for Indian pharma exports with strong provided 5,000 IU of vitamin A. In the
growth of 24.9 per cent to Rs 1500.25
short term, too much vitamin A may
crore as against Rs 1201.31 crore in
India's pharmaceutical cause nausea and blurred vision, and,
the last period. However, Russian
in the long-term, may lead to bone

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VOL.2, NO.3 OF MARCH, 2009

softening and liver problems. (Reuters trials," according to a release. Q10 not covered by GMP is optional.
Health dt. April 11th, 2009) However, by adopting the additional
CII to organise 2-day With the robust infrastructural set up, processes outlined in the US Food and
India can emerge as a preferred Drug Administration’s (FDA) guidance
international meet on manufacturers should benefit from the
destination for clinical research and
clinical trials in Mumbai play a key role in drug discovery to innovation and continual improvement
from Oct 23 final product process. India on the that are central tenets of ICH Q10. In
regulatory side also has taken a addition unlike GMP ICH Q10 explicitly
New Delhi: The Institute of Quality at covers all aspects of a product’s
number of initiatives to provide a good
the Confederation of Indian Industries lifecycle, from development through to
environment, the release added.
(CII) is organising a two-day discontinuation, and is designed to
Academicians, clinical development
international conference on clinical strengthen the link between pre- and
groups, medical directors, clinical
trials at Mumbai from October 23 to post-commercialisation manufacturing
research associates, project personnel,
create widespread sensitisation on activities.
data personnel, report writers,
clinical trial methodology and to
regulatory officials and biostatisticians
provide an in-depth knowledge on the
can attend the conference, to be guided (in-pharmatechnologist.com dt.
subject. The conference on 'drug
by experts in the field. April 10th, 2009)
discovery to final product' will bring
together all stakeholders dealing US FDA issues final
directly and indirectly in the area. guidance on ICH Q10 Govt plans to restart
state-run Kasauli
Scientific sessions on different streams Maryland: The FDA has provided a vaccine making unit
of clinical research operations, model for implementing the ICH Q10
pharmacovigilance, regulatory affairs, quality control system in its final New Delhi: Facing flak over halting
qualification validation, and safety audit guidance, which is intended help production of essential vaccines at
will be conducted at the conference, manufacturers adapt processes three state-owned drug makers, the
according to the organisers. "India is throughout a product’s lifecycle. By ministry of health and family welfare is
the signatory of the WTO agreement building upon good manufacturing likely to let the Central Research
and the second largest populated practices (GMP) the International Institute (CRI) to resume production,
country in the world with large pool of Conference on Harmonization's (ICH) two persons familiar with the matter
patient population, well-developed Q10 attempts to provide a said. “We have submitted a proposal to
hospitals, talented work force, and comprehensive model for an effective the DGHS (Directorate General of
strong regulatory environment. Many of quality management system. Health Services) to invest Rs13-14
the companies globally are looking for crore in CRI Kasauli (in Himachal
an alternative destination to conduct The implementation of aspects of ICH Pradesh) to resume production there.

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VOL.2, NO.3 OF MARCH, 2009

This should be approved soon,” said a Indian plants offer new CDC Finds Rocket Fuel
ministry official, who declined being source for Tamiflu precursor Chemical in U.S. Baby
named. The proposal comes after Formula
officials from the ministry and the Drug Bangalore: Researchers believe they
Controller General of India visited the have found “more promising” sources of Maryland: A rocket fuel chemical called
Kasauli facility last month. The ministry shikimic acid, a precursor in the perchlorate was found in samples of
official quoted was part of the visiting production of Tamiflu, shortages of powdered baby formula tested by U.S.
team. (Livemint dt. April 8th, 2009) which have previously caused Centers for Disease Control and
bottlenecks in producing the bird flu Prevention scientists, but it's not clear
vaccine. Tamiflu demand outstripped how much of a health threat it poses to
USP-India to focus on
production in 2005 owing in part to a infants. The largest amounts of
standard setting shortage of shikimic acid, which is perchlorate were found in baby formula
activities currently harvested from star anise fruit derived from cow's milk, said the
in China and produced in genetically researchers, who wouldn't disclose the
Chennai: USP India, United States modified Escherichia coli. brands of formula they analyzed, the
Pharmacopoeia's Indian chapter, will
Associated Press reported.
focus on developing and revising its
Roche has now managed to increase
standard setting activities in India, said
production to above the current levels of Scientists have said significant amounts
Ashok Dang, senior manager of USP-
demand but the fear remains that in the of perchlorate can affect the function of
India Ltd. The company will encourage
event of a pandemic a shortage of the thyroid, which helps set the body's
the Indian pharmaceutical companies in
shikimic acid would again become a metabolism. Fetal and infant brain
developing higher manufacturing
factor. Consequently researchers from development can be affected by thyroid
standards. With its experienced
Bangalore in Southern India began problems. But the level of risk posed by
scientists, USP-India will provide USP's
bioprospecting in the Western Ghats in the trace amounts of perchlorate in baby
broad range of pharmacopoeial services
an attempt to find an alternative, more formula is difficult to assess, the AP
to customers in India and surrounding
easily cultivable source of shikimic acid. reported. Formula sold in the United
countries, he said. United States
Pharmacopoeia is neither part of US States must contain iodine, which
government nor a regulatory authority The research has now been published in counteracts perchlorate's effects. Other
in the US. It is a standard setting Current Science, with the results factors that influence risk include the
organization. In India, it is registered suggesting that some plants in the infant's size and how much formula they
as USP India Private Limited, he added. region could provide viable alternative consume. Potential health risks weren't
(Pharmabiz dt. April 7th, 2009) sources of shikimic acid. (in-pharma examined in the CDC study, which was
technologist dt. April t5th, 2009) published last month. The
Environmental Working Group issued a

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VOL.2, NO.3 OF MARCH, 2009

press release Thursday to draw public NEW DELHI: The government has said for manufacturing of
attention to the study. (Health Day dt. that it will prepare the domestic drug Rasaushadhies or
April 3rd, 2009) industry to meet new regulatory Rasamarunthukal and
challenges in the US market, which
arose due to implementation of the Food
Kushtajat (Herbo-mineral-
Two Indian pharma cos metallic compounds) of
and Drug Administration (FDA)
sued for 'inferior supply of Globalisation Act 2009. An unaware Ayurveda, Siddha and Unani
medicines' in Sri Lanka domestic firm may face threat of losing medicines notified
authorisation for marketing its drugs in
Mumbai: The Court of Appeal in Sri the US, said a government official. The New Delhi: Ministry of health and
Lanka has issued notices to two US market is about 50% of India’s Rs family welfare (Department of Ayurveda,
Chennai-based pharmaceutical 30,000-crore drugs export. Indian Yoga and Naturopathy, Unani, Siddha
manufacturers and their local agent in pharmaceutical firms export relatively and Homeopathy) vide notification No.
Sri Lanka on a writ petition seeking cheaper generics to the country. The US GSR 157 (E) dated 4th March, 2009 has
suspension of their registration to supply government has recently introduced the notified Drug and Cosmetics (3rd
drugs to the Sri Lankan Health new law to strengthen its drug quality Amendment) Rules, 2009 in exercise of
Department. According to reports, the control system. the powers conferred by section 33-N of
petitioner Arushan Raninkumar, a the Drugs and Cosmetics Act, 1940 (23
businessman, complained that the of 1940). These Rules shall come into
The ministries of commerce and industry
Director General of Health Services and force from the date of their publication
and chemicals and fertilisers are
the State Pharmaceutical Corporation, in the Official Gazette ie 4th/9th march,
planning to conduct awareness
the drug distribution agency under the 2009.
programmes for the industry. As per
state government, had failed to take
the new law, all medical and health,
action to claim reimbursement for the In the Drugs and Cosmetics Rules,
including imported drugs and medical
supply of inferior quality drugs worth Rs 1945, in Schedule T, in Part II, in item
devices, are required to be registered
3,500 million from the Chennai-based C, relating to “List Of Equipment
with the USFDA. The registration will be
Madras Pharmaceuticals, Bafna Recommended For In-House Quality
reviewed periodically and exporters will
Pharmaceuticals and their local agent, Control Section,” before note, the “D.
be required to pay an annual
Pharma Associations, Colombo. Supplementary guidelines for
registration fee. The registration would
(Pharmabiz dt. April 2nd, 2009) manufacturing of Rasaushadhies or
be done only after physically verifying
the manufacturing facilities. (Economic Rasamarunthukal and Kushtajat (Herbo-
Centre to help drug cos Times dt. April 3rd, 2009) mineral-metallic compounds) of
meet stringent US quality Ayurveda, Siddha and Unani medicines”
laws guidelines are inserted. These guidelines
Supplementary guidelines are intended to complement those

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VOL.2, NO.3 OF MARCH, 2009

provided earlier and should be read in DCGI Dr Surinder Singh has stated that "Hepatitis C is responsible for as many
conjunction with the parent guidelines. this is just the phase 1 and we want to as one in four cases of liver cancer and
The supplementary guidelines are to go for two or three more phases to 20 per cent of chronic liver disease is
provide general and minimum technical cover the other left out therapeutic because of Hepatitis C. However if
requirement for quality assurance and segments too. Our target is to test detected early, hepatitis C can be cured,
control in manufacturing Rasaushadhis between 80,000 and 100,000 samples in while hepatitis B treatment only
or Rasamarunthukal and Kustjat (Herbo- different phases and get a complete suppresses the infection,"
mineral-metallic formulations). picture on the extent of spurious drugs. Gastroenterology department head at
We have sought budgetary provision for the AIIMS Dr S K Acharya opined.
holding the next phase also," he said. (Pharmabiz dt. March 31st, 2009)
(Pharmabiz dt. March 31at, 2009)
Results of spurious drugs'
survey expected by may
end, govt collected 24000 12.5 million Indians suffer
samples from hepatitis C virus, says
INASL
New Delhi: The results of the much- AP's state-owned drug
awaited official survey to ascertain the New Delhi: Every 15th carrier of the distribution body caught
quantum of spurious drugs in the hepatitis C virus (HCV) is an Indian and passing on recalled product
country are likely to come out by the 12.5 million Indians suffering from HCV,
end of May as the process of analysing with the death rate exceeding over one Mumbai: The state owned Andhra
the samples were in the final stages in lakh per year, according to the Indian Pradesh Health Medical Housing
the labs. The CDSCO had collected over National Association for the Study of Infrastructure Development Corporation
24,000 samples, more than 80 per cent Liver (INASL). The key to successfully has been caught distributing recalled
of the targeted 25,000 samples, from tackling the challenge of chronic batch of Clanoxy 375 mg tablet, an
different therapeutic categories and the hepatitis is awareness and public amoxicillin preparation, manufactured
same have been sent for lab tests. The education and INASL is committed to by the Mumbai-based Galpha
results of the keenly awaited survey, the cause of tackling this menace with Laboratories Ltd, through primary health
undertaken by the DCGI office, are specific projects to facilitate physician centres. The drug control officials seized
expected to put at rest the controversies education, along with efforts to drive 1100 numbers of Clanoxy 375 mg
about the extent of spurious drugs in community level immunization tablets with batch number COT 7031 IB
the country. programmes, the national conference of distributed by the central drug store.
the organisation said.

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VOL.2, NO.3 OF MARCH, 2009

Details of 100 discussions held over NetRUM so far

Moderator Discussion topic Duration Best posting Number of


award to posts

Dr Anand Chaudhary Pharmacovigilance of Ayurvedic medicines 28-31 Mar


2009

Dr Anita Kotwani Adherance to STG for Asthma in the community 19-24 Mar
2009

Dr Anita Kotwani Medicine prices in India - Who cares? 10-16 Dec


2007

Dr Anupama Sucklecha Six sigma in healthcare 01-09 Jun


2008

Dr Anupama Sukhlecha Problems in choice of brand names 11-20 Jul


2007

Dr Anupama Sukhlecha Pharmacoeconomics - light on pocket 11-17 Oct


2007

Dr Anupama Sukhlecha Irrational use of nutritional supplements 01-08 Feb


2008

Dr Anupama Sukhlecha Protecting health from climate change 16-22 Jun


2008

MONTHLY NEWSLETTER OF THE NETWORK FOR RATIONAL USE OF MEDICINES Page 21


VOL.2, NO.3 OF MARCH, 2009

Dr Anupama Sukhlecha National immunization schedule - Is it being 07-13 Aug


followed? 2008

Dr Anupama Sukhlecha Cautions in using computers 26-30 Oct


2008

Dr Anupama Sukhlecha Doping in sports 01-07 Apr


2008

Dr Anupama Sukhlecha Rationale of cosmeceuticals 01-07 May


2008

Dr Anupama Sukhlecha The challenges in research funding 09-13 Sep


2008

Dr B. Gitanjali Drug quality 01-05 Nov


2008

Dr Bharat Gajjar Should medicines be prescribed by generic or 20-28 May


brand names? 2007

Dr Bharat Gajjar Justification for OTC sale of medicines 05-11 Aug


2007

Dr Bharat Gajjar Role of Pharmacologists in community health 02-10 Sep - 1965


care. 2007

Dr Bharat Gajjar Modern medicines in drinking water 09-16 Apr


2008

Dr Bharat Gajjar Agricultural products(Fertilizers and Pesticides) 10-16 May

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VOL.2, NO.3 OF MARCH, 2009

as xenobiotics. 2008

Dr Bharat Gajjar Integrated teaching in medical curriculum 01-06 Oct


2008

Dr Bharat Gajjar Selection of topic for dissertation / research O2-12 Jan Dr Narendra
2007 Bachewar

Dr Bharat Gajjar Research protocol designing 01-12 Feb Dr. Anupama


2007 Sukhlecha

Dr Chaitali Bajait Concept of 'P' medicine 18-23 Dec


2008

Dr Chetna Desai 98. Coexistence of pathies 10-15 Apr


2009

Dr Chetna Desai How to conduct sponsored clinical trials in an 10-21 Jun


ethical manner? 2007

Dr Chetna Desai Scientific Journals in Pharmacology - What 01-10 Jul


makes a good, useful and balanced reading? 2007

Dr Chetna Desai Are medicine samples ethical? 20-27 Oct


2007

Dr Chetna Desai How to make PG curriculum in Pharmacology 01-10 Nov Dr. Kiran Chaudhari
adequate for current needs 2006

Dr Chetna Desai Use of computers and internet in teaching- 20 - 30 Dec


learning 2006

MONTHLY NEWSLETTER OF THE NETWORK FOR RATIONAL USE OF MEDICINES Page 23


VOL.2, NO.3 OF MARCH, 2009

Dr Chetna Desai Medical ethics - Relevant but difficult to 01-07 Sep


implement - Reasons and possible solutions 2008

Dr Chetna Desai Medical research ethics 28 Nov-03


Dec 2008

Dr Deepali Tehre Access to controlled medication 10-14 Mar


2008

Dr Fatai Fehintola Altrenative medicine:Perspectives, perception 10-17 Feb


and practice 2008

Dr Galib Traditional medicine: Panacea or poison? 12-17 Mar


2009

Dr Geer M Ishaq Pharm. D. Course in India -Prospects & 04-09 Dec


constraints 2008

Dr Geer M Ishaq Need for regional, state-specific medicine policy 19-24 Oct
2008

Dr Geer M Ishaq The menace of spurious medicines 23-29 Jun


2008

Dr Kiran Barar Problem of compliance with the use of ARV 10-21 Dec
drugs 2006

Dr Kiran Barar Role of telemedicine in RUM 14-20 Aug


2007

Dr Kiran Chaudhari Impact of health insurance on medicine pricing 09-13 Feb

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VOL.2, NO.3 OF MARCH, 2009

2009

Dr Kiran Chaudhari Indian Medlars 24-28 Feb


2009

Dr Kiran Chaudhari Role of pharmacogenomics in rational use of 10-16 Jan


medicine 2008

Dr Kiran Chaudhari Orphan medicines - are they getting any shelter? 17-22 Apr
2008

Dr Kiran Chaudhari Closure of vaccine PSUs in India 01-05 Aug


2008

Dr Kiran Chaudhari RSS - for convenient search downloads 08-10 Oct


2008

Dr Kiran Chaudhari Ancillary care in clinical trials 13-17 Oct


2008

Dr Kiran V. Barar Role of proteomics in new drug development 16-20 Nov


2008

Dr Mangesh Bankar 97. Need for developing consumer information 3-8 Apr 2009
on traditional medicine

Dr Mangesh Bankar Thearpeutic utility of monoclonal antibodies 03-08 Mar


2008

Dr Mangesh Bankar IPR and access to essential medicines 25-29 Jul


2008

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VOL.2, NO.3 OF MARCH, 2009

Dr Mangesh Bankar Proliferation of nonessential medicines 06-10 Nov


2008

Dr Mangesh Bankar Advocacy in medicines 16-21 Jan


2009

Dr Mangesh Bankar Rationality of HPV vaccine 25-30 Aug


2008

Dr Manoj Swaminathan Promotion of condom use 10-21 Dec


2006

Dr Manoj Swaminathan How to succeed with the National 21-30 Jul


Pharmacovigilance Programme? 2007

Dr Manoj Swaminathan Repercussions of pharmaceutical company take 16-22 Jul


over in developing economies 2008

Dr Mira Desai Medicine promotion : Are we promoting science 23-29 Aug


or sales ? 2007

Dr Mira Desai Off label use of medicines 28 Nov-02


Dec 2007

Dr Mira Desai Ethical issues in medicine development 18 - 30 Nov Dr. Narendra


2006 Bachewar

Dr Mira Desai Emergency contraceptives as OTC in India : 22-26 Sep


boon or curse ? 2008

Dr Mira Desai Evaluation methods in medical education: 11-15 Nov

MONTHLY NEWSLETTER OF THE NETWORK FOR RATIONAL USE OF MEDICINES Page 26


VOL.2, NO.3 OF MARCH, 2009

Contemporary versus new 2008

Dr Mohd Bashaar Good governance in health sector 05-10 Mar


2009

Dr Mohd Bashaar The Gulran / camel belly/ charmak disease in 01-07 Jul
Afghanistan 2008

Dr Mohd Bashaar Mother & child morbidity and mortality rates in 20-24 Aug
Afghanistan 2008

Dr S. Ziaur Rahman Rational use of investigations for diagnosis 26-31 Jan


2008

Dr Smita Mali Safe medicines for children 20-27 Nov


2007

Dr Smita Mali Rationale of reverse pharmacology 25-28 Mar


2008

Dr Smita Sontakke WHO pre-qualification program 11-15 Jun


2008

Dr Smita Sontakke Counterfeit medicines 03-10 Oct


2007

Dr Smita Sontakke Publication ethics 01-05 Jan


2009

Dr Trupti Swain Rational use of analgesics 17-23 Mar


2008

MONTHLY NEWSLETTER OF THE NETWORK FOR RATIONAL USE OF MEDICINES Page 27


VOL.2, NO.3 OF MARCH, 2009

Dr Trupti Swain Rational use of Anti malarial medicines 10-17 Nov


2007

Dr Trupti Swain Pro-active management of natural disasters 25-30 Dec


2008

Dr Trupti Swain Rational use of antimicrobials 20-26 Dec


2007

Dr Trupti Swain Rational use of medicines in respiratory 9-14 Jul 2008


infections

Dr Vijay Thawani Inclusion of RUM in UG curriculum 16-28 Oct Dr. Mira Desai
2006

Dr Vijay Thawani The games in medicine pricing 19-31 Jan Tauqueer Mustafa
2007 Choudhry

Dr Vijay Thawani Should life saving medicines be taxed by the 01-10 May
Government? 2007

Dr Vijay Thawani Should inducement be offered for 14-19 May


vaccination/nutritional supplement programmes? 2007

Dr Vijay Thawani Need of antimicrobial policy for institutional 24-29 Jun 1123-
hospitals 2007

Dr Vijay Thawani Should doctors accept free gifts, tours,money ? 20-22 Aug
2007

Dr Vijay Thawani Misuse of WHO name in medicine promotion 24-28 Apr

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VOL.2, NO.3 OF MARCH, 2009

2008

Dr Vijay Thawani (100) The pleasures and pains of NetRUM 24-28 Apr
2009

Dr Vijay Thawani & Dr Anand Safety and efficacy of Ayurvedic formulations 08-13 Jan
Chaudhary 2009

Dr Vijaya Chaudhari International ethical guidelines for medical 24-29 Jan


research 2009

Dr Vijaya Chaudhari (99) Is narco analysis ethical? 17-22 Apr


2009

Dr Yashashri Shetty and Dr Mohd Status of OTC medicines 15-20 Sep


Bashaar 2008

Drs Narendra Bachewar, Sarang Making RUM compulsory for prescribers 11-18 Sep
Deshmukh, Smita Mali and Deepali 2007
Tehre.

Mrs Kunda Gharpure Pros & cons of generic policies 01-06 Feb
2009

Mrs Kunda Gharpure Essential medicines as a human right 16 Feb - 2 Dr. Manoj
Mar 2007 Swaminathan

Mrs Kunda Gharpure Why Pharmacovigilance? 01-09 Jun


2007

Mrs Kunda Gharpure Is patient the king in deciding his medicine? 24-30 Sep

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VOL.2, NO.3 OF MARCH, 2009

2007

Mrs Kunda Gharpure ATC and DDD - What we learnt at WHO 01-08 Jan
Technical Briefing Seminar. 2008

Mrs Kunda Gharpure Rabies and other neglected envenomings 20-24 Feb
2008

Mrs Kunda Gharpure Role of pharmacists in rational use of medicines. 25-31 May
2008

Mrs Kunda Gharpure Improving access to medicines 11-16 Dec


2008

Rajendra Diwe Doctors as selling agents 21-24 May


2007

Rajendra Diwe Rationale of hepatitis B vaccination 15-19 Aug


2008

Ram Charitra Sah Bio-medical waste management 01-07 Nov


2007

Ram Charitra Sah Mercury in the health care system 22-27 Nov
2008

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VOL.2, NO.3 OF MARCH, 2009

Schedule of Forthcoming Netrum Discussions


DISCUSSION NAME OF MODERATOR TOPIC OF DISCUSSION PERIOD OF
NO. DISCUSSION

101 Dr Swapnil Jaiswal Gene therapy 01-05 May 2009

102 Dr Trupti Swain Medicine use problems in elderly 08-13 May 2009

103 Dr Anupama Sukhlecha Drug abuse 15-20 May 2009

104 Dr Anand Chaudhary Problem and solutions to global 25-31 May 2009
acceptance of Ayurveda as system of
medicine

105 Dr Geer M Ishaq Does combination HRT offer any 03-08 Jun 2009
safety?

106 Dr Trupti Swain Rational use of steroids 11-15 Jun 2009

HAPPY NETWORKING

MONTHLY NEWSLETTER OF THE NETWORK FOR RATIONAL USE OF MEDICINES Page 31

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