Good Governance in Health Sector 2009

MONTHLY NEWSLETTER OF THE NETWORK FOR RATIONAL USE OF MEDICINES Page 1

VOL.2, NO.3 OF MARCH, 2009

NetRUM NewsletteR©

Vol. 2, No. 3 of

March 2009



NetRUM is a not-for-profit, voluntary, co-operative, non-funded, E-discussion group of like-minded rationalists without any conflict of interest. It is three years young and has >415 members globally. NetRUM was born on March 16, 2006 during the training course on promoting rational use of medicines held in collaboration with WHO's EDOM, SEARO. NetRUM continuously conducts E-discussions on hot topics, which are facilitated by knowledgeable moderators who offer their valuable, expert and free services. About 200-300 messages are posted on NetRUM every month. So far NetRUM has conducted 99 discussions moderated by 30 moderators. For more details please visit our group: http://health.groups.yahoo.com/group/netrum/

GROUP OWNER: Dr. Vijay Thawani Associate Professor Dept. of Pharmacology, Govt. Medical College, Nagpur – 440 003, India [email protected] NEWSLETTER EDITOR: Dr. Geer M. Ishaq Assistant Professor, Dept. of Pharmaceutical Sciences University of Kashmir Srinagar, J&K, India EDITORIAL COORDINATOR: Dr. Smita Mali Senior Resident in Pharmacology, Govt. Medical College, Nagpur – 440 003, India

http://health.groups.yahoo.com/group/netrum/�



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

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



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?


Name of Moderator: Dr. Ghalib

3. Adherence to STG for asthma in the community


Name of Moderator: Dr. Anita Kotwani

4. Pharmacovigilace of ayurvedic medicines Period of Discussion: 26 – 31 Feb., 2009

Name of Moderator: Dr. Anand Chaudhary

DISCUSSIONS HELD DURING FEBRUARY 2009



“Good governance in health sector”

ABOUT THE MODERATOR

Dr. Mohammad Bashaar graduated from Kabul Medical University with major in Curative Medicine and obtained his Masters degree in Health Management from Preston University. At present he is working for United Nations Development Programme in Afghanistan besides serving as a lecturer in Karwan Medical Institute Kabul, Afghanistan. Dr. Bashaar has participated in many national and international events; his last visit to India being in April, 2008 when he presented a paper on the Health Status of Afghanistan post 9/11 at The Jawaharlal Nehru University, New Delhi. Dr Bashaar is a medical activist with dynamism and determination, vision and voice which can be heard. He has relentlessly been trying to assist in repair of the health system of his war ravaged motherland.

Good governance in health generally refers to the enhancement of the stewardship functions and the improvement of management support systems of government in terms of its responsibility for the overall performance of the health system. Good governance stands for the aim of bringing together administrative bodies and all relevant stakeholders (citizens, NGOs, industry, etc) to implement reforms improving the living conditions for all people.

The concept of good governance is increasingly being discussed in the context of public health. This article explains what exactly is meant by this buzzword, how good governance can be justified and how it can be

translated into public health practice for the betterment of the population. Governance means decision-making and the implementation of decisions. These decisions can be made within all different kinds of social institutions and arrangements and relate to communities, corporations, national and international levels. Good governance is a concept articulated and conceptualized in the context of development and development aid. It was influentially formulated by the United Nations Economic and Social Commission for Asia and the Pacific (UNESCAP). Good governance was meant to ensure that developing countries are free from oppression and corruption and thus can prosper in wealth and health.



CHARACTERISTICS OF GOOD GOVERNANCE

Good governance has eight major characteristics. It is participatory, consensus-oriented, accountable, transparent, responsive, effective and efficient, equitable and inclusive and follows the rule of law.

Participation

Participation by men as well as women is the cornerstone of good governance. Participation could be either direct or through legitimate intermediate institutions or representatives, such as parliamentary and provincial council elections.

Rule of law

Good governance requires fair legal frameworks that are enforced impartially. It also requires full protection of human rights countrywide. Impartial enforcement of

laws requires an independent judiciary and an impartial and incorruptible police force. Health is a fundamental human right, indispensable for the full enjoyment of other human rights.

Every human being is entitled to the enjoyment of the highest attainable standard of health conducive to living a life in dignity. The right to health in all its forms and at all levels contains the following interrelated and essential elements, the precise application of which will depend on the conditions prevailing in a particular State party: (a) Availability, (b) Accessibility, (c)

Acceptability and (d) Quality (e) Adequate sanitation

Transparency

Transparency means that information is freely available and directly accessible to those who will be affected by such decisions and their enforcement. According to Transparency International, transparency is “a principle that allows those affected by administrative decisions, business transactions or charitable work to know not only the basic facts and figures but also the mechanisms and processes. It is the duty of civil servants, managers and trustees to act visibly, predictably and understandably.”

Responsiveness

Good governance requires that institutions and processes must try to serve all stakeholders within a reasonable timeframe. Here everyone



who is working in health sector (from gatekeeper to health minister) has the prime responsibility to perform the duties with honesty and dedication.

Consensus oriented

Good governance requires mediation of different interests in society to reach a broad consensus in society on what is in the best interests of the whole community and how this can be achieved. All men and women should have a voice in decision making for health, either directly or through legitimate intermediate institutions that represent their interests. Such broad participation is built on freedom of association and speech, as well as capacities to participate constructively.

Equity and inclusiveness

A society’s well being depends on ensuring that all its members have the sense of involvement as stakeholder in it so that they do not feel excluded

from the mainstream of society. This requires all groups, particularly the most vulnerable, to have equal opportunities to maintain and improve their well being.

Effectiveness and efficiency

Good governance means that processes and institutions produce results that meet the needs of society while making the best use of resources at their disposal. The concept of efficiency in the context of good governance also covers the sustainable use of natural resources and the protection of the environment.

Accountability

Accountability is a key requirement of good governance. Not only governmental institutions but also the private sector and civil society organizations must be accountable to the public. In general an organization or an institution is accountable to those

who will be affected by its decisions or actions. Accountability cannot be enforced without transparency and the rule of law.

Main regimes involved in good governance There are three main regimes involved in good governance. They are the State, the Civil Society and the Private Sector. All three are critical for sustaining human development. Since each one has its weaknesses and strengths, a major objective of good governance is to promote highest possible constructive interaction among the three in order to minimize individual weaknesses and utilize the strengths optimally. According to Dr. Vijay Thawani, “If the power really rested with people, governance of others will not be needed. It is only that the populations are not empowered and therefore are not self-sufficient; they look at governance from others. The very fact that some govern; there are others who are governed by them. Hence in terms of health empowerment, the



word governance is not in good taste. Because it concentrates on governance, it can never be good! No governance in the world has ever been good, so how can governance in health be?” Sh. Ram Charitra Sah from Nepal feels, “Good governance is required for all and it is not only the business of civil society. It is preferable to use the word Society rather than Civil Society, considering most part of the society mostly comprises of civilized people”. As per Dr. Geer M. Ishaq, “Lack of robust, comprehensive and region specific health and medicine policies at national, state, district and hospital level in most of the economically developing and under developed countries is a major impediment in effective health administration”. It is very true that robust and comprehensive health and pharmaceutical policies are essential at all levels of the nation in order to ensure good health administration and governance.

Corruption in the health sector

Corruption in the healthcare sector is a concern for all countries, but it is especially a critical problem in developing and transitional economies where public resources are already scarce. Corruption reduces the resources available for health, lowers the quality, equity and effectiveness of healthcare services, decreases the volume and increases the cost of provided services. Embezzlement in health sector

Embezzlement is defined as the misappropriation of property or funds legally entrusted to someone in their formal position as an agent or guardian. Everyone wants to believe that the people they hire are good employees who can be trusted to perform their responsibilities with integrity.

Conclusion

Good governance does not merely stand for effective management in the health sector. It is a broadly used term, but new in health sector, which needs

different strategies for its implementation. In order to ensure good governance in health, it is imperative to implement all those strategies which are quite basic. The execution of good governance strategies and practices is not only the responsibility of the state or government, but it is also the job of civil society and private sector and both of them should be equally accountable to the government. ACKNOWLEDGEMENT My warm gratitude goes to Dr. Vijay Thawani, who not only participated in the discussion but provided all of us an opportunity to work together to promote good governance for health as well as Rational Use of Medicines. I am also very thankful to Dr. Smita Mali, who invited me for the discussion and obliged to Dr. Anupama Sukhlecha, Dr. Geer M. Ishaq, Elizabeth Ominde-Ogaja, 'Ranti Opanuga, and Ram Charitra Sah for their active participation and valuable ideas.

- Dr. Mohammad Bashaar



“Traditional Medicine: Panacea or Poison?”

Maintaining positive state of health and freedom from diseases are the fundamental objectives of Ayurveda. To achieve these, ancient seers of Ayurveda tried a number of laudable measures and found that the resources of different origin (Herbal / Animal / Mineral / Marine etc) are most suitable to accomplish the goals. Hence these resources were converted into four types of formulations viz. Herbal, Herbo-Mineral, Mineral and Metallic, to which a vast range of therapeutic properties have been attributed. The science touched its new dimensions after having been incorporated with the knowledge of Rasaushadhies (pure metallic and mineral preparations) from 8th A.D. onwards. Since then the metals and minerals have been used abundantly in many dosage forms and Rasa Shastra (the science dealing with different processes of mercury and

other metals / minerals) became an integral part of Ayurveda. The long history of usage of metallic preparations in varied pathological manifestations is enough proof for their safe, effective and nontoxic beneficial effects.

In the recent years, use of Ayurvedic medicines, particularly of herbal origin has increased substantially world over. The greater usage has resulted in number of problems like increased commercialization, pressure on harvesting, adoption of short cuts, adulteration, development of formulations without conceptual basis of Ayurvedic scriptures, incorrect use by consumers and quacks, lack of awareness of practitioners about pharmacovigilance of Ayurvedic formulations and free communication across borders etc. In addition to this,

ABOUT THE MODERATOR

Dr. Galib is working as Lecturer at the Dept. of Rasa Shastra (Ayurvedic Pharmaceutics), Institute for Post Graduate Teaching & Research in Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat. He has completed his graduation from BRKR Govt. Ayurvedic College, Hyderabad, Andhra Pradesh, followed by MD (Ayurveda) from National Institute of Ayurveda, Jaipur. Dr. Galib has more than 50 publications to his credit.



a few of the western scientists raised unfounded concern about safety and toxicity of these time tested formulations. Particularly the Rasaushadhies [Metallic / Mineral Preparations] have been repeatedly targeted by western scientists, which have affected the reputation of traditional Ayurvedic heritage. Ayurvedic medicines sold over internet have been reported to have high levels of heavy metal concentrations. After such reports, obviously the present generation became apprehensive about the quality standards and safety of the metallic compounds and some of the NetRUMians also raised queries regarding these aspects during E-discussions.

Unregulated, injudicious and inappropriate use of Ayurvedic medicines and practices definitely leads to the causation of negative or dangerous effects. For instance, the herb “Ma Huang” (Ephedra) is traditionally used in China to treat

respiratory congestion. In the United States, this herb was marketed as a dietary supplement, available OTC, whose over dosing led to about dozen deaths, heart attacks and strokes. Hence the mute question whether the system is wrong or the drug is poisonous? We feel the attitude towards the drug is wrong. Though the drugs are traditional in origin, they should always be used with proper care and under qualified supervision. WHO Guidelines 2004 clearly state that the drugs if improperly processed and if used injudiciously may tend to cause certain inconveniencies.

The metallic/mineral preparations have occupied coveted position in Ayurvedic pharmacopoeia and have been routinely used in India since centuries. The Ayurvedic literature says that these preparations will be safe, efficacious even at minute doses and never develop any significant untoward effects if manufactured in accordance with specified guidelines. The founders

of Ayurveda considered in great detail the possible ways by which untoward effects can occur and provided all necessary guidelines to avoid the occurrence of such effects. They preferred on exercising great caution while administering drugs for therapeutic purposes. “Primum non nocere” meaning "first do no harm" was preached and practiced both while approving new drugs, as well as prescribing the established ones to patients. It implies that, there is a chance of getting ADRs with utilization of classical drugs, if prepared in an inappropriate manner or if administered injudiciously. Hence the Gurus prescribed different processing techniques to remove the hazardous ingredients or properties, if any, from these. They also prescribed testing methods for the prepared products, which will tell the manufacturer whether the drug has attained the form that does not have hazardous properties when used properly by a physician.



The accusation that Ayurvedic drugs are toxic because they contain heavy metals is based on ignorance. We agree that to say that Ayurvedic drugs are safe because they have been used since thousands of years, is also not very scientific. If any ADR or adverse events develop, it is due to the poor product quality or improper use. Weak quality control systems and inadequate regulatory measures contribute to it. To promote and improve the quality, and to reduce the proportion of ADR attributable to poor quality, WHO GMP updated guidelines for herbals and updated core guidelines on GMP need to be followed.

To revalidate the safety and efficacy of age old remedies, many scientific studies have been conducted at various post graduate institutions throughout India, which prove the necessity and significance of the sanskaras (specific guidelines to be mandatorily followed while dealing with metals, minerals or other toxic drugs)

in detoxifying the material and making them potent and suitable for therapeutic application. Reputed teaching institutions like Gujrat Ayurved University, Banaras Hindu University have focused research on metals and minerals like mercury, lead, arsenic and herbo-mineral /metallic preparations to screen through relevant analytical and pharmacological parameters. Most of the studies confirmed that the metals/minerals when converted into the medicines by strictly following the advocated classical guidelines of ancient texts, were devoid of toxicity even at the levels of 100 TEDs. The histopathological studies on different visceral organs also did not reveal any apparent pathological damage with use of these.

In-vivo condition many preparations containing metals bind with peptides or other functional groups. It is essential to identify these molecules that bind to the metals, as well as their

concentrations. This needs the techniques suitable for separation and identification of the various bio-molecules bound to these metals as well as methods to estimate their concentrations. The emerging area of proteomics and metallomics aims at providing information to enable better understanding of the mechanism by which these preparations exhibit therapeutic effects. Additionally there is need to carry out biochemical estimation of anti-oxidants which are responsible for the protection of cells with respect to free radical induced damages. It is possible that the therapeutic efficacy of certain Ayurvedic drugs could be through the production of anti-oxidants.

It is well known that the exposure to heavy metals is countered by the in-situ synthesis of phyto-chelatins in plants and metallothionines in animals. Such investigations in humans are needed to determine the mode of action of the metallic preparations. In



order to instill confidence in the medical community, it is imperative to carry out bio-chemical studies to understand the action of Ayurvedic drugs at the molecular level. It is felt that:

Skepticism should not be there about use of the metals/minerals. To achieve this, there is need to provide scientific basis to the use of use of TM.

Bio-chemical basis to the Ayurvedic formulations needs to be developed to answer the scientific questions like what are the new bio-molecules synthesized in the body on the consumption of these medicines; which are the body tissues that accumulate these metals and in what molecular form; the relation between the dose and the mode of excretion.

Cell line studies are essential to find out the actual pharmacokinetics and dynamics of the metallic/mineral preparations.

Comprehensive database to substantiate the actual efficacy and safety on all the metals/minerals.

Implementing stringent quality control methods.

To revalidate the actual safety and efficacy, stratified clinical trials can be initiated to confirm the efficacy, provide accuracy and confirm the safety in a scientific manner. Govt. of India through GTP, where AYUSH, CSIR and ICMR are the active partners, is doing exclusive work on metallic, herbo-mineral compound formulations. We hope that in near future the results of these studies will be a boon to the Ayurveda. A comprehensive database covering all these findings will definitely provide a substantial answer to the concerns raised by the western scientists on safety and efficacy of metals and minerals.

I acknowledge kind participation of all members of the NetRUM in this

discussion. Acknowledgements are due to the constant backup provided by Dr Vijay Thawani.

- Dr Galib



ABOUT THE MODERATOR

Dr Anand Chaudhary is Associate Professor in Rasa Shastra (Ayurvedic Pharmaceutics), Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi. He did his graduation from Allahabad University in 1986; BAMS from the University of Kanpur in 1993, followed by MD in 1997 and PhD in 2002 from BHU. His areas of interest include Ayurvedic Pharmaceutics of herbals, Stability profile of Ayurvedic medicines and regulatory affairs. He has 68 publications to his credit.

“Pharmacovigilance of Ayurvedic Medicines”

Pharmacovigilance (PV) is a science concerned with activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug related problems. Specific goals of PV are:

1- Improve patient care and safety in relation to use of medicines and other interventions.

2- Improve public health and safety in relation to the use of medicines.

3- Contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost effective) use.

4- Promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.

The discussion focused upon origin and implementation of the PV

programme for medicines of Ayurvedic, Sidha and Unani (ASU) systems. Subsequent upon receiving reports of many adverse drug reactions (ADRs) of medicines belonging to these systems, there has been a constant surge in the demand to address this specific issue with reliable and genuine expertise. Consequent upon insistence by the WHO, Dept. of AYUSH, Ministry of Health & Family Welfare, Govt of India started substantial steps for planning and execution of a comprehensive PV programme for ASU medicines. After a series of consultations and draft meetings, this programme was launched for ASU medicines on 29th September, 2008 by the then Commissioner-Secretary, Health & FW, Ms. Anita Das with establishment of National Pharmacovigilance Centre for ASU Drugs at Institute of Post Graduate



Teaching and Research in Ayurveda, Gujarat Ayurveda University, Jamnagar. Later this centre identified eight regional centers and thirty peripheral centers all over the country. It is pertinent to ponder whether these centers will adopt the same methodology for ASU as followed for allopathic medicines or develop a separate specific protocol for ASU systems. Experts of ASU systems visualized that the concept of safety and precautions specified for these systems for their manufacture and administration are in tandem with the aims and objectives of PV. Although exact term for PV in Sanskrit language does not figure in Ayurvedic texts, the spirit of PV is vibrant in the scriptures and is emphasized repeatedly in all major samhitas viz. Charak Samhita, Sushruta Samhita and Astang Hridaya to name a few. Acharya Charak narrated several factors about medicines right from harvesting, procurement, preparation etc which

should be considered before their administration into the patients for proper therapeutic effects. Any deviation from these standard operating procedures leads to many ADRs. This has been specifically emphasized in the description of Charak Samhita, Sutra Sthana, Chapter 1, Verse No. 126 which means, “Even an acute poison can become an excellent medicine if it is properly administered; on the other hand, a potent medicine can prove to be an acute poison if administered improperly.” In light of this, the present discussion was taken up in which members raised their apprehensions and doubts about drug interactions, drug herb interactions, problem of multi-constituent formulations, their manufacturing procedures and other aspects which were mostly due to lack of awareness about ASU medicines. Before giving misleading facts about the science of life, it has to be kept in mind that ASU systems have

nourished and nurtured the human civilizations for centuries. In India, British imposed a legal ban in 1835 on the practice of these systems of medicine and opened medical colleges in English system of medicine throughout the country. There were comments that since aspirin interacts with herbs, we should dump all Ayurvedic medicines in Indian Ocean and in view of the reports of lead poisoning with some ASU medicines, Ayurveda must be banned all over the globe. They conveniently forgot the endless reports of morbidity and ever increasing ADRs due to new and old synthetic molecules in the allopathic system of medicine. Being a student of Ayurvedic pharmaceutics, I salute our ancestors for discovering more than 123 dosage forms out of which at present we are practicing not more than 35 formulations. Their wisdom and farsightedness is evident from the fact that even before the terms like



galenicals or pharmaceutics came into being, Ayurvedic and Unani procedures were invented by them. One of the NetRUMian suggested some good terms like Ayurgenomics, Herboprint and digitalization of knowledge vide Ayusoft, Rudra etc. We welcome these suggestions with full sincerity and one may be pleased to know that CSIR has done wonderful job on such aspects. I express my heartfelt indebtedness to those pioneers who invested their precious time to study medicines belonging to ASU systems and produced the valuable works before the world with concrete evidence. I request all learned members of NetRUM to have a look on the findings of SASTRA, Thanjavur and notification of Govt of India dated Sept 3rd , 2009 on these issues, most important being the statement of Robert Saper from Boston, during the convention of IPA at New Delhi in Dec 2008. We have enough education, power and insight

to understand such disinformation and have the ability to differentiate between the correct and wrong arguments about ASU medicines. However shortcomings do exist in every growing science which need to be overcome and same holds true ASU. It is necessary that these need to be improved to ensure globalized acceptance of our indigenous systems of medicine. While we adopt latest technology in every walk of our life, we need to apply the basic principles of core sciences to develop suitable technologies for the advancement of these systems of medicine so that without compromising on the fundamentals, we may be able to develop such dosage forms of ASU that are free from ADRs. Further it needs to be ascertained whether reported ADRs are produced by genuine ASU medicines or by other spurious, adulterated and misbranded products.

Members are requested to be assured about the safety and efficacy of Ayurvedic medicines. However GMP should be in place and necessary quality control for the validation of these medicines should be taken up on priority basis. The PV of ASU medicines with a positive frame of mind has just started and like any other new approach, is suffering from teething problems, which will certainly vanish as we grow up. In the end, I humbly convey my deep sense of gratitude to all members of NetRUM for providing their constructive and critical suggestions on this issue. Prof Vijay Thawani deserves a special mention for encouraging me to take responsibilities of the moderator in spite of some hindering odds. My affectionate appreciations for Prof Vijay Thawani and his team are also due for all the painstaking work at NetRUM, especially to our young editor Dr Geer M. Ishaq for his dedicated hard work. - Dr. Anand Chaudhary



News Briefs Relating to Rational Use of Medicines

Health ministry to add Schedule Y1 to D&C Rules to

streamline clinical trials sector

New Delhi: The Health Ministry is planning to incorporate a new schedule 'Y1' to the Drugs and Cosmetic Rules 1945, to specify all rules regarding clinical trials including guidelines for registration of trials, penalty provisions for defaults, registration of ethics committees and on-site audits of trials. The draft guidelines on trials and requirements for registration of clinical research organisations, prepared by an expert panel, and proposed amendment in rules have already been approved by the Drug Technical Advisory Board (DTAB) and the DCC, and are waiting to be notified. After the approval of the minutes of the last DTAB meeting, the guidelines are likely to be announced, sources said. It is also proposed to incorporate Rule 122DAB for the proposed new Schedule Y1, it is learnt. (Pharmabiz dt. April 13th, 2009)

India's pharmaceutical

export goes up by 28% in April-Dec 2008

Mumbai: Pharmaceutical exports from India increased by 28.1 per cent during the first nine months ended December 2008 to Rs 36,878 crore from Rs 28,786 crore in the corresponding period of last year. As per the Pharmaceuticals Export Promotion Council (Pharmexcil) the exports in December 2008 went up sharply by 80.4 per cent to Rs 4,934 crore from Rs 2,735 crore. The exports to top 25 countries contributed over 66 per cent at Rs 24,389 crore as against 52 per cent to Rs 19,183 crore. In dollar terms, the exports have recorded 21 per cent growth from $6.98 billion to $8.45 billion. Despite economic slowdown and stiff competition, the exports during the first nine months of 2008-09 in the US moved up by 23.1 per cent to Rs 6,657 crore from Rs 5,409 crore in the same period of last year. The exports to US worked out to 18.1 per cent of the total exports. Russia stood second largest destination for Indian pharma exports with strong growth of 24.9 per cent to Rs 1500.25 crore as against Rs 1201.31 crore in the last period. However, Russian

exports contributed only 4.1 per cent to Indian pharma exports. (Pharmabiz dt. April 13th, 2009)

Report warns of

problems with multivitamins

NEW YORK - More than 30 percent of multivitamins tested recently by ConsumerLab.com contained significantly more or less of an ingredient than claimed, or were contaminated with lead, the company reports. Several multivitamin products tested, including three for children, exceeded tolerable upper limits established by the Institute of Medicine for ingredients such as vitamin A, folic acid, niacin and zinc, according to the report posted on www.ConsumerLab.com. For example, the Institute of Medicine sets a recommended daily allowance (RDA) of 1,300 international units (IU) of vitamin A for children ages 4 to 8 years and an upper tolerable limit of 3,000 IU. However, one multivitamin tested provided 5,000 IU of vitamin A. In the short term, too much vitamin A may cause nausea and blurred vision, and, in the long-term, may lead to bone



softening and liver problems. (Reuters Health dt. April 11th, 2009)

CII to organise 2-day international meet on

clinical trials in Mumbai from Oct 23

New Delhi: The Institute of Quality at the Confederation of Indian Industries (CII) is organising a two-day international conference on clinical trials at Mumbai from October 23 to create widespread sensitisation on clinical trial methodology and to provide an in-depth knowledge on the subject. The conference on 'drug discovery to final product' will bring together all stakeholders dealing directly and indirectly in the area.

Scientific sessions on different streams of clinical research operations, pharmacovigilance, regulatory affairs, qualification validation, and safety audit will be conducted at the conference, according to the organisers. "India is the signatory of the WTO agreement and the second largest populated country in the world with large pool of patient population, well-developed hospitals, talented work force, and strong regulatory environment. Many of the companies globally are looking for an alternative destination to conduct

trials," according to a release.

With the robust infrastructural set up, India can emerge as a preferred destination for clinical research and play a key role in drug discovery to final product process. India on the regulatory side also has taken a number of initiatives to provide a good environment, the release added. Academicians, clinical development groups, medical directors, clinical research associates, project personnel, data personnel, report writers, regulatory officials and biostatisticians can attend the conference, to be guided by experts in the field.

US FDA issues final guidance on ICH Q10

Maryland: The FDA has provided a model for implementing the ICH Q10 quality control system in its final guidance, which is intended help manufacturers adapt processes throughout a product’s lifecycle. By building upon good manufacturing practices (GMP) the International Conference on Harmonization's (ICH) Q10 attempts to provide a comprehensive model for an effective quality management system.

The implementation of aspects of ICH

Q10 not covered by GMP is optional. However, by adopting the additional processes outlined in the US Food and Drug Administration’s (FDA) guidance manufacturers should benefit from the innovation and continual improvement that are central tenets of ICH Q10. In addition unlike GMP ICH Q10 explicitly covers all aspects of a product’s lifecycle, from development through to discontinuation, and is designed to strengthen the link between pre- and post-commercialisation manufacturing activities.

(in-pharmatechnologist.com dt. April 10th, 2009)

Govt plans to restart

state-run Kasauli vaccine making unit

New Delhi: Facing flak over halting production of essential vaccines at three state-owned drug makers, the ministry of health and family welfare is likely to let the Central Research Institute (CRI) to resume production, two persons familiar with the matter said. “We have submitted a proposal to the DGHS (Directorate General of Health Services) to invest Rs13-14 crore in CRI Kasauli (in Himachal Pradesh) to resume production there.



This should be approved soon,” said a ministry official, who declined being named. The proposal comes after officials from the ministry and the Drug Controller General of India visited the Kasauli facility last month. The ministry official quoted was part of the visiting team. (Livemint dt. April 8th, 2009)

USP-India to focus on

standard setting activities

Chennai: USP India, United States Pharmacopoeia's Indian chapter, will focus on developing and revising its standard setting activities in India, said Ashok Dang, senior manager of USP-India Ltd. The company will encourage the Indian pharmaceutical companies in developing higher manufacturing standards. With its experienced scientists, USP-India will provide USP's broad range of pharmacopoeial services to customers in India and surrounding countries, he said. United States Pharmacopoeia is neither part of US government nor a regulatory authority in the US. It is a standard setting organization. In India, it is registered as USP India Private Limited, he added. (Pharmabiz dt. April 7th, 2009)

Indian plants offer new source for Tamiflu precursor Bangalore: Researchers believe they have found “more promising” sources of shikimic acid, a precursor in the production of Tamiflu, shortages of which have previously caused bottlenecks in producing the bird flu vaccine. Tamiflu demand outstripped production in 2005 owing in part to a shortage of shikimic acid, which is currently harvested from star anise fruit in China and produced in genetically modified Escherichia coli.

Roche has now managed to increase production to above the current levels of demand but the fear remains that in the event of a pandemic a shortage of shikimic acid would again become a factor. Consequently researchers from Bangalore in Southern India began bioprospecting in the Western Ghats in an attempt to find an alternative, more easily cultivable source of shikimic acid.

The research has now been published in Current Science, with the results suggesting that some plants in the region could provide viable alternative sources of shikimic acid. (in-pharma technologist dt. April t5th, 2009)

CDC Finds Rocket Fuel Chemical in U.S. Baby

Formula

Maryland: A rocket fuel chemical called perchlorate was found in samples of powdered baby formula tested by U.S. Centers for Disease Control and Prevention scientists, but it's not clear how much of a health threat it poses to infants. The largest amounts of perchlorate were found in baby formula derived from cow's milk, said the researchers, who wouldn't disclose the brands of formula they analyzed, the Associated Press reported.

Scientists have said significant amounts of perchlorate can affect the function of the thyroid, which helps set the body's metabolism. Fetal and infant brain development can be affected by thyroid problems. But the level of risk posed by the trace amounts of perchlorate in baby formula is difficult to assess, the AP reported. Formula sold in the United States must contain iodine, which counteracts perchlorate's effects. Other factors that influence risk include the infant's size and how much formula they consume. Potential health risks weren't examined in the CDC study, which was published last month. The Environmental Working Group issued a

http://en.wikipedia.org/wiki/Perchlorate�



press release Thursday to draw public attention to the study. (Health Day dt. April 3rd, 2009)

Two Indian pharma cos sued for 'inferior supply of

medicines' in Sri Lanka

Mumbai: The Court of Appeal in Sri Lanka has issued notices to two Chennai-based pharmaceutical manufacturers and their local agent in Sri Lanka on a writ petition seeking suspension of their registration to supply drugs to the Sri Lankan Health Department. According to reports, the petitioner Arushan Raninkumar, a businessman, complained that the Director General of Health Services and the State Pharmaceutical Corporation, the drug distribution agency under the state government, had failed to take action to claim reimbursement for the supply of inferior quality drugs worth Rs 3,500 million from the Chennai-based Madras Pharmaceuticals, Bafna Pharmaceuticals and their local agent, Pharma Associations, Colombo. (Pharmabiz dt. April 2nd, 2009)

Centre to help drug cos

meet stringent US quality laws

NEW DELHI: The government has said that it will prepare the domestic drug industry to meet new regulatory challenges in the US market, which arose due to implementation of the Food and Drug Administration (FDA) Globalisation Act 2009. An unaware domestic firm may face threat of losing authorisation for marketing its drugs in the US, said a government official. The US market is about 50% of India’s Rs 30,000-crore drugs export. Indian pharmaceutical firms export relatively cheaper generics to the country. The US government has recently introduced the new law to strengthen its drug quality control system.

The ministries of commerce and industry and chemicals and fertilisers are planning to conduct awareness programmes for the industry. As per the new law, all medical and health, including imported drugs and medical devices, are required to be registered with the USFDA. The registration will be reviewed periodically and exporters will be required to pay an annual registration fee. The registration would be done only after physically verifying the manufacturing facilities. (Economic Times dt. April 3rd, 2009)

Supplementary guidelines

for manufacturing of Rasaushadhies or

Rasamarunthukal and Kushtajat (Herbo-mineral-

metallic compounds) of Ayurveda, Siddha and Unani

medicines notified New Delhi: Ministry of health and family welfare (Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy) vide notification No. GSR 157 (E) dated 4th March, 2009 has notified Drug and Cosmetics (3rd Amendment) Rules, 2009 in exercise of the powers conferred by section 33-N of the Drugs and Cosmetics Act, 1940 (23 of 1940). These Rules shall come into force from the date of their publication in the Official Gazette ie 4th/9th march, 2009.

In the Drugs and Cosmetics Rules, 1945, in Schedule T, in Part II, in item C, relating to “List Of Equipment Recommended For In-House Quality Control Section,” before note, the “D. Supplementary guidelines for manufacturing of Rasaushadhies or Rasamarunthukal and Kushtajat (Herbo-mineral-metallic compounds) of Ayurveda, Siddha and Unani medicines” guidelines are inserted. These guidelines are intended to complement those



provided earlier and should be read in conjunction with the parent guidelines. The supplementary guidelines are to provide general and minimum technical requirement for quality assurance and control in manufacturing Rasaushadhis or Rasamarunthukal and Kustjat (Herbo-mineral-metallic formulations).

Results of spurious drugs' survey expected by may

end, govt collected 24000 samples

New Delhi: The results of the much-awaited official survey to ascertain the quantum of spurious drugs in the country are likely to come out by the end of May as the process of analysing the samples were in the final stages in the labs. The CDSCO had collected over 24,000 samples, more than 80 per cent of the targeted 25,000 samples, from different therapeutic categories and the same have been sent for lab tests. The results of the keenly awaited survey, undertaken by the DCGI office, are expected to put at rest the controversies about the extent of spurious drugs in the country.

DCGI Dr Surinder Singh has stated that this is just the phase 1 and we want to go for two or three more phases to cover the other left out therapeutic segments too. Our target is to test between 80,000 and 100,000 samples in different phases and get a complete picture on the extent of spurious drugs. We have sought budgetary provision for holding the next phase also," he said. (Pharmabiz dt. March 31at, 2009)

12.5 million Indians suffer from hepatitis C virus, says

INASL

New Delhi: Every 15th carrier of the hepatitis C virus (HCV) is an Indian and 12.5 million Indians suffering from HCV, with the death rate exceeding over one lakh per year, according to the Indian National Association for the Study of Liver (INASL). The key to successfully tackling the challenge of chronic hepatitis is awareness and public education and INASL is committed to the cause of tackling this menace with specific projects to facilitate physician education, along with efforts to drive community level immunization programmes, the national conference of the organisation said.

"Hepatitis C is responsible for as many as one in four cases of liver cancer and 20 per cent of chronic liver disease is because of Hepatitis C. However if detected early, hepatitis C can be cured, while hepatitis B treatment only suppresses the infection," Gastroenterology department head at the AIIMS Dr S K Acharya opined. (Pharmabiz dt. March 31st, 2009)

AP's state-owned drug

distribution body caught passing on recalled product

Mumbai: The state owned Andhra Pradesh Health Medical Housing Infrastructure Development Corporation has been caught distributing recalled batch of Clanoxy 375 mg tablet, an amoxicillin preparation, manufactured by the Mumbai-based Galpha Laboratories Ltd, through primary health centres. The drug control officials seized 1100 numbers of Clanoxy 375 mg tablets with batch number COT 7031 IB distributed by the central drug store.



Details of 100 discussions held over NetRUM so far

Moderator Discussion topic Duration Best posting award to

Number of 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

http://health.groups.yahoo.com/group/netrum/database?method=reportRows&tbl=1&sortBy=1&sortDir=up�

http://health.groups.yahoo.com/group/netrum/database?method=reportRows&tbl=1&sortBy=2�








Dr Anupama Sukhlecha National immunization schedule - Is it being followed?

07-13 Aug 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 brand names?

20-28 May 2007

Dr Bharat Gajjar Justification for OTC sale of medicines 05-11 Aug 2007

Dr Bharat Gajjar Role of Pharmacologists in community health care.

02-10 Sep 2007

- 1965

Dr Bharat Gajjar Modern medicines in drinking water 09-16 Apr 2008

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



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 2007

Dr Narendra Bachewar

Dr Bharat Gajjar Research protocol designing 01-12 Feb 2007

Dr. Anupama 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 ethical manner?

10-21 Jun 2007

Dr Chetna Desai Scientific Journals in Pharmacology - What makes a good, useful and balanced reading?

01-10 Jul 2007

Dr Chetna Desai Are medicine samples ethical? 20-27 Oct 2007

Dr Chetna Desai How to make PG curriculum in Pharmacology adequate for current needs

01-10 Nov 2006

Dr. Kiran Chaudhari

Dr Chetna Desai Use of computers and internet in teaching-learning

20 - 30 Dec 2006



Dr Chetna Desai Medical ethics - Relevant but difficult to implement - Reasons and possible solutions

01-07 Sep 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 and practice

10-17 Feb 2008

Dr Galib Traditional medicine: Panacea or poison? 12-17 Mar 2009

Dr Geer M Ishaq Pharm. D. Course in India -Prospects & constraints

04-09 Dec 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 drugs

10-21 Dec 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



2009

Dr Kiran Chaudhari Indian Medlars 24-28 Feb 2009

Dr Kiran Chaudhari Role of pharmacogenomics in rational use of medicine

10-16 Jan 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 on traditional medicine

3-8 Apr 2009

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



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 Pharmacovigilance Programme?

21-30 Jul 2007

Dr Manoj Swaminathan Repercussions of pharmaceutical company take over in developing economies

16-22 Jul 2008

Dr Mira Desai Medicine promotion : Are we promoting science or sales ?

23-29 Aug 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 2006

Dr. Narendra Bachewar

Dr Mira Desai Emergency contraceptives as OTC in India : boon or curse ?

22-26 Sep 2008

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



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 Afghanistan

01-07 Jul 2008

Dr Mohd Bashaar Mother & child morbidity and mortality rates in Afghanistan

20-24 Aug 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



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 infections

9-14 Jul 2008

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

Dr. Mira Desai

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

Tauqueer Mustafa Choudhry

Dr Vijay Thawani Should life saving medicines be taxed by the Government?

01-10 May 2007

Dr Vijay Thawani Should inducement be offered for vaccination/nutritional supplement programmes?

14-19 May 2007

Dr Vijay Thawani Need of antimicrobial policy for institutional hospitals

24-29 Jun 2007

1123-

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



2008

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

Dr Vijay Thawani & Dr Anand Chaudhary

Safety and efficacy of Ayurvedic formulations 08-13 Jan 2009

Dr Vijaya Chaudhari International ethical guidelines for medical research

24-29 Jan 2009

Dr Vijaya Chaudhari (99) Is narco analysis ethical? 17-22 Apr 2009

Dr Yashashri Shetty and Dr Mohd Bashaar

Status of OTC medicines 15-20 Sep 2008

Drs Narendra Bachewar, Sarang Deshmukh, Smita Mali and Deepali Tehre.

Making RUM compulsory for prescribers 11-18 Sep 2007

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

Mrs Kunda Gharpure Essential medicines as a human right 16 Feb - 2 Mar 2007

Dr. Manoj Swaminathan

Mrs Kunda Gharpure Why Pharmacovigilance? 01-09 Jun 2007

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



2007

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

01-08 Jan 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



Schedule of Forthcoming Netrum Discussions

DISCUSSION NO.

NAME OF MODERATOR TOPIC OF DISCUSSION PERIOD OF 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 acceptance of Ayurveda as system of

medicine

25-31 May 2009

105 Dr Geer M Ishaq Does combination HRT offer any safety?

03-08 Jun 2009

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

HAPPY NETWORKING

Date post:	10-Apr-2015
Category:	Documents
Upload:	ulfat
View:	833 times
Download:	0 times

Good Governance in Health Sector 2009

Documents