Prices of commonly-used medicines have gone up by nearly 10% every year for the last 10 years. This is much more than the country's inflation rate and higher than annual increase in income of the common man.
The drugs include popular antibiotics such as ampicillin, and painkillers like as paracetamol and diclofenac.
The study by drug watchdog, National Pharmaceutical Pricing Authority (NPPA), was carried out on the top 15 drugs. The medicines, which have recorded a 10% increase in prices every year are those, which are not under prices notified by the government.
This has happened even as the prices of bulk drugs (raw material) have been coming down drastically every year. Interestingly, in a sample covering top 15 drugs that were under government control, the annualized increase is only about 1%. The period under study in both the samples was over 12 years, from 1994-end till July 2007.
The study strengthens the government's case to increase its ambit of price control to cover 354 essential medicines from the existing 74 drugs. The issue — part of the draft pharma policy, was referred to a group of ministers. But this has not yet been finalised. However, the industry has a contrary view.
"Prices have gone up because of the higher transaction costs which include excise duty and margins to retailers and distributors," an executive with an industry player said.
The problem in the country is more to do with delivery, rather than high prices. Moreover, the industry needs to invest in research and development which requires massive investments, he added.
Not only have drug prices shot up, but cases of over-charging and selling without government approval have also been discovered. In about 660 samples of scheduled drugs (under price control) collected from 12 cities over three months this year, there have been prima-facie violations relating to charging more than the price decided by the government in nearly 60% of the cases.
The government is expected to issue notices to the companies that have been over-charging or selling without approval soon, official sources said. Over 2006-07, the drug watchdog received 83-odd complaints from 479 scheduled packs, of which a majority were related to over-charging, while a few were concerned with sale without government approval.
State governments have started throwing their weight behind the Centre, which is about to finalise a new drug policy allowing the government to fix prices of more drugs. Some states have told the Centre that drug makers who promised to reduce prices of 886 brands while negotiating a softer drug pricing formula with the government have delivered poorly on their commitment.
The feedback from state governments on the availability and pricing of medicines comes in the wake of a crucial meeting of a ministerial panel on the new policy, probably the final one, was scheduled for the first week of November. Possibility of early elections could encourage the group of ministers headed by Arjun Singh to take feedback from state governments seriously.
The Tamil Nadu government, for example, has conveyed to the Centre that none of the 886 formulation packs (brands in the form of a particular quantity of a medicine of a particular strength), on which leading companies have committed to reduce prices, are available in the state. Some states in the North East have said not more than three or four of these drugs are available in chemist shops there. The West Bengal government is understood to have told the Centre that only about 30% of these drugs are available in the state.
Interestingly, some companies have either modified their brand names or changed the pack size or the strength of the medicine, it is understood. The feedback from far-flung markets is expected to be a strong tool for the government while finalising a new pricing formula.
The drug industry feels the offer to lower prices of 886 formulation packs was made to persuade the government not to go ahead with its proposal to price control all drugs in the national list of essential drugs.
Drug price watchdog NPPA had recently asked companies to explain why they have not honoured their commitments. More importantly, it has asked them to explain the violations noticed in the case of these drugs.
Many brands on which they offered to slash prices were in the market without the mandatory government-fixed prices in the first place.
Economic Times, 25 Oct, 2007
The Times of India, Nov 14, 2007
Friday, November 16, 2007
Diabetes drug Avandia/Windia in danger zone
The United States’s Food and Drug Administration has directed pharmaceutical major GlaxoSmithKline (GSK), a British based pharmaceutical, biological, and healthcare company.to put a “black box” warning on its diabetesdrug Avandia, stating that its use could cause chest pain or heart attack. Over two million people worldwide take the drug for Type-II diabetes.
Generic versions of Avandia — its scientific name is rosiglitazone maleate — are available under 10 brand names in India and sold to about eight million people. In India, GSK sells it under Windia brand name.
A “black box” warning is the FDA’s strongest warning, falling just short of withdrawing the drug from the market. The warning is made mandatory when studies indicate the drug carries a significant risk of serious or life-threatening side effects.
Concerns about Avandia’s safety started when a study in The New England Journal of Medicine in May reported that patients who used it had a 43 per cent higher risk of heart attack and a 64 per cent higher risk of dying of heart problems.
“We are keeping Avandia in the market because we have concluded that there isn’t enough evidence to conclude the risk for heart attack or cardiac ischemia is higher than for other Type-II diabetes drugs,” said the FDA’s Dr Janet Woodcock.
GSK will start a trial comparing Avandia with other drugs to see whether the cardiovascular risks are unique to it alone.
In India, no such warning on rosiglitazone has been issued by the Drugs Controller General Dr M. Venkateswarlu.
Rosiglitazone is popular here because besides regulating insulin and blood sugar, it is found to have a favourable impact on lipids (blood fats like cholesterol), coagulation (clotting) and fat in liver. It is a third-line drug prescribed after two lines of treatment — like sulfisoxazole and metformin — become ineffective. Many firms here were promoting it as a drug that prevents diabetes.
The lesson in this, says Dr Anoop Misra, head, department of metabolic diseases, Fortis Group of Hospitals, is that both physicians and patients should refrain from blindly accepting new medicines as cure-alls when existing therapies have been established to be equally effective.
“The mechanism for increased risk of death from heart attacks may be due to the adverse effect of rosiglitazone on lipids, particularly because of the increase in bad cholesterol by 18.6 per cent. The drug was claimed to ‘have a favourable effect on lipids’ when launched, which is a false claim,” said Dr C.M. Gulati, drug specialist and editor of the Monthly Index of Medical Specialities.
16, November, 2007
Hindustan Times
Generic versions of Avandia — its scientific name is rosiglitazone maleate — are available under 10 brand names in India and sold to about eight million people. In India, GSK sells it under Windia brand name.
A “black box” warning is the FDA’s strongest warning, falling just short of withdrawing the drug from the market. The warning is made mandatory when studies indicate the drug carries a significant risk of serious or life-threatening side effects.
Concerns about Avandia’s safety started when a study in The New England Journal of Medicine in May reported that patients who used it had a 43 per cent higher risk of heart attack and a 64 per cent higher risk of dying of heart problems.
“We are keeping Avandia in the market because we have concluded that there isn’t enough evidence to conclude the risk for heart attack or cardiac ischemia is higher than for other Type-II diabetes drugs,” said the FDA’s Dr Janet Woodcock.
GSK will start a trial comparing Avandia with other drugs to see whether the cardiovascular risks are unique to it alone.
In India, no such warning on rosiglitazone has been issued by the Drugs Controller General Dr M. Venkateswarlu.
Rosiglitazone is popular here because besides regulating insulin and blood sugar, it is found to have a favourable impact on lipids (blood fats like cholesterol), coagulation (clotting) and fat in liver. It is a third-line drug prescribed after two lines of treatment — like sulfisoxazole and metformin — become ineffective. Many firms here were promoting it as a drug that prevents diabetes.
The lesson in this, says Dr Anoop Misra, head, department of metabolic diseases, Fortis Group of Hospitals, is that both physicians and patients should refrain from blindly accepting new medicines as cure-alls when existing therapies have been established to be equally effective.
“The mechanism for increased risk of death from heart attacks may be due to the adverse effect of rosiglitazone on lipids, particularly because of the increase in bad cholesterol by 18.6 per cent. The drug was claimed to ‘have a favourable effect on lipids’ when launched, which is a false claim,” said Dr C.M. Gulati, drug specialist and editor of the Monthly Index of Medical Specialities.
16, November, 2007
Hindustan Times
Tuesday, November 13, 2007
An unhealthy practice
Four years after Mumbai-based Sun Pharmaceuticals was found unauthorisedly promoting and marketing letrozole, a drug prescribed for advanced breast cancer in postmenopausal women, for treating infertility in women, it has been cleared by the Indian Drugs Controller-General for that very purpose.
What is shocking is that this approval has come despite the drug, developed by the Swiss company Novartis, being clearly marked contra-indicative for infertility treatment and in t he absence of results from clinical trials that were designed and conducted properly. Since the drug approved in 1998 by the U.S. Food and Drug Administration was for treating advanced breast cancer, using the same drug for other purposes, would, by default, make it a new drug warranting full fledged clinical trials before regulatory approval.
While animal studies conducted by the original developer have found harmful effects on the foetus when the drug is administered during the period of organogenesis, trials are under way on women for treating infertility and a clear verdict is yet to be returned. In fact, many of these trials do not meet the stringent requirements of the U.S. FDA or the European Agency for the Evaluation of Medicinal Products.
That the approval by the Indian authorities was based on cursory studies and was not backed by sufficient domestic clinical trial data makes a mockery of the country’s drug approval system. While there are instances where off-label use of a drug has “led the way while industry and regulatory agencies trailed behind,” such uses were not for conditions for which the drug was originally found to be contra-indicative.
Though there are cases where drug manufacturers discourage the use of the drugs for unapproved conditions even when it has some desirable effects on patients, the way the Indian authorities have gone about approving letrozole leaves much to be desired.
The letrozole experience does not portend well for a country that expects to be seen as a preferred destination for clinical trials.
Editorial
The Hindu
13 November, 2007
What is shocking is that this approval has come despite the drug, developed by the Swiss company Novartis, being clearly marked contra-indicative for infertility treatment and in t he absence of results from clinical trials that were designed and conducted properly. Since the drug approved in 1998 by the U.S. Food and Drug Administration was for treating advanced breast cancer, using the same drug for other purposes, would, by default, make it a new drug warranting full fledged clinical trials before regulatory approval.
While animal studies conducted by the original developer have found harmful effects on the foetus when the drug is administered during the period of organogenesis, trials are under way on women for treating infertility and a clear verdict is yet to be returned. In fact, many of these trials do not meet the stringent requirements of the U.S. FDA or the European Agency for the Evaluation of Medicinal Products.
That the approval by the Indian authorities was based on cursory studies and was not backed by sufficient domestic clinical trial data makes a mockery of the country’s drug approval system. While there are instances where off-label use of a drug has “led the way while industry and regulatory agencies trailed behind,” such uses were not for conditions for which the drug was originally found to be contra-indicative.
Though there are cases where drug manufacturers discourage the use of the drugs for unapproved conditions even when it has some desirable effects on patients, the way the Indian authorities have gone about approving letrozole leaves much to be desired.
The letrozole experience does not portend well for a country that expects to be seen as a preferred destination for clinical trials.
Editorial
The Hindu
13 November, 2007
Monday, November 12, 2007
Understanding Stem Cell Research -1
On 8th November, 2007 the Indian Council of Medical Research (ICMR) and the Department of Biotechnology that has finalized extensive guidelines for embryonic stem cell research after five years of discussion submitted them to the Union health ministry. These guidelines have been prepared for public debate. It envisages two committees: a National Apex Committee for Stem Cell Research and Therapy and an Institutional Committee for Stem Cell Research and Therapy.
Earlier there was a “Ethical guidelines for Biomedical Research on HumanSubjects” issued by the ICMR in October, 2000. In 2004, ICMR had prepared a Draft Guidelines for Stem Cell Research/Regulation in India that has noted sources of stem cells as follows:
i) Adult stem cell : Derived from peripheral blood, tissue or bone marrow
ii) Cord Blood Cell : Derived from placenta
iii) Embryonal stem cells: Derived either from blastocysts or foetal tissues
Meanwhile, on 5 November, 2007, Kapil Sibal, Union Minister for Science & Technology laid the foundation stone for nation’s first Clinical Research Facility (CRF) for Stem Cells and Regenerative Medicine (CRF) on a five-acre site at Uppal in Hyderabad by the Centre for Cellular and Molecular Biology (CCMB) along with Nizam’s Institute of Medical Sciences. The Minister revealed that in aspects of embryonic and adult stem cell research more than 40 institutions and hospitals in country are involved and a Bill is planned to be introduced to provide incentives or 30 per cent of license fee as royalty to scientists to encourage them for research.
It is noteworthy that so far human cloning is banned everywhere. The UN General Assembly adopted the United Nations Declaration on Human Cloning, by which Member States were called on to adopt all measures necessary to prohibit all forms of human cloning inasmuch as they are incompatible with human dignity and the protection of human life on 8th March, 2005 by a vote of 84 in favour to 34 against, with 37 abstentions. World opinion is divided on the possibilities of therapeutic cloning. India is on the side of the partial ban.
It is significant to note that India had voted against the UN Declaration. However, the immediate issue facing the Indian policymakers is embryonic stem cell research that includes harvesting stem cells from embryos in order to treat diseases, such as Alzheimer’s, or diabetes, or even cancer, destroy, in the present state of technology, the embryos from which the cells are taken.Stem cells are obtained from foetuses, embryos, the umbilical cord and bone marrow.
Countries representing about 3.5 billion people have a permissive or flexible policy on human embryonic stem cell research and all have banned human reproductive cloning.
Can the logic of scientific progress be barred by concerns that are social and ethical in the matter of stem cell research?
Is it not always possible that a banned activity will go underground?
Should possibility of abuse prevent research leading to healing and greater knowledge?
Note: The Draft Guidelines for Stem Cell Research/Regulation in India were prepared by the Expert Group Members and Drafting Committee as mentioned below:
Expert Group Members
1. Dr. P.N. Tandon, New Delhi Chairman
2. Dr. S.S. Agarwal, ACTREC, Mumbai
3. Dr. N.K. Mehra, AIIMS, New Delhi
4. Dr. Dipika Mohanty, IIH, Mumbai
5. Dr. Y.N. Rao, DGHS, New Delhi
6. Ashwini Kumar, DCGI, New Delhi
7. Dr. Narayan Swamy, Dy. DCGI, New Delhi
8. Dr. Hari Gopal, DST, New Delhi
9. Dr. T.S. Rao, DBT, New Delhi
10. Dr. Alka Sharma, DBT, New Delhi
11. Dr. C.M. Habibullah, DCMC & Allied Hospitals, Hyderabad
12. Dr. U.V. Wagh, NCCS, Pune
13. Dr. Vinod Raina, AIIMS, New Delhi
14. Dr. Vineeta Salvi, KEM, Mumbai
15. Dr. Satish Kumar, CCMB, Hyderabad
16. Dr. G.R. Chandak, CCMB, Hyderabad
17. Dr. Ambika Nanu, AIIMS, New Delhi
18. Dr. S.G.A. Rao, Reliance, Mumbai
Drafting Committee
1. Dr. A.N. Bhisey, CRI, Mumbai Chairman
2. Dr. U.V. Wagh, NCCS, Pune
3. Dr. D. Mohanty, IIH, Mumbai
4. Dr. P.B. Seshagiri, IISc, Bangalore
5. Dr. M.G. Deo, Moving Academy, Pune
6. Dr. V. Salvi, KEM, Mumbai
7. Dr. S.S. Agarwal, ACTREC, Mumbai
8. Dr. K. Ghosh, IIH, Mumbai
9. Dr. V. Muthuswamy, ICMR, New Delhi Member Secretary
Earlier there was a “Ethical guidelines for Biomedical Research on HumanSubjects” issued by the ICMR in October, 2000. In 2004, ICMR had prepared a Draft Guidelines for Stem Cell Research/Regulation in India that has noted sources of stem cells as follows:
i) Adult stem cell : Derived from peripheral blood, tissue or bone marrow
ii) Cord Blood Cell : Derived from placenta
iii) Embryonal stem cells: Derived either from blastocysts or foetal tissues
Meanwhile, on 5 November, 2007, Kapil Sibal, Union Minister for Science & Technology laid the foundation stone for nation’s first Clinical Research Facility (CRF) for Stem Cells and Regenerative Medicine (CRF) on a five-acre site at Uppal in Hyderabad by the Centre for Cellular and Molecular Biology (CCMB) along with Nizam’s Institute of Medical Sciences. The Minister revealed that in aspects of embryonic and adult stem cell research more than 40 institutions and hospitals in country are involved and a Bill is planned to be introduced to provide incentives or 30 per cent of license fee as royalty to scientists to encourage them for research.
It is noteworthy that so far human cloning is banned everywhere. The UN General Assembly adopted the United Nations Declaration on Human Cloning, by which Member States were called on to adopt all measures necessary to prohibit all forms of human cloning inasmuch as they are incompatible with human dignity and the protection of human life on 8th March, 2005 by a vote of 84 in favour to 34 against, with 37 abstentions. World opinion is divided on the possibilities of therapeutic cloning. India is on the side of the partial ban.
It is significant to note that India had voted against the UN Declaration. However, the immediate issue facing the Indian policymakers is embryonic stem cell research that includes harvesting stem cells from embryos in order to treat diseases, such as Alzheimer’s, or diabetes, or even cancer, destroy, in the present state of technology, the embryos from which the cells are taken.Stem cells are obtained from foetuses, embryos, the umbilical cord and bone marrow.
Countries representing about 3.5 billion people have a permissive or flexible policy on human embryonic stem cell research and all have banned human reproductive cloning.
Can the logic of scientific progress be barred by concerns that are social and ethical in the matter of stem cell research?
Is it not always possible that a banned activity will go underground?
Should possibility of abuse prevent research leading to healing and greater knowledge?
Note: The Draft Guidelines for Stem Cell Research/Regulation in India were prepared by the Expert Group Members and Drafting Committee as mentioned below:
Expert Group Members
1. Dr. P.N. Tandon, New Delhi Chairman
2. Dr. S.S. Agarwal, ACTREC, Mumbai
3. Dr. N.K. Mehra, AIIMS, New Delhi
4. Dr. Dipika Mohanty, IIH, Mumbai
5. Dr. Y.N. Rao, DGHS, New Delhi
6. Ashwini Kumar, DCGI, New Delhi
7. Dr. Narayan Swamy, Dy. DCGI, New Delhi
8. Dr. Hari Gopal, DST, New Delhi
9. Dr. T.S. Rao, DBT, New Delhi
10. Dr. Alka Sharma, DBT, New Delhi
11. Dr. C.M. Habibullah, DCMC & Allied Hospitals, Hyderabad
12. Dr. U.V. Wagh, NCCS, Pune
13. Dr. Vinod Raina, AIIMS, New Delhi
14. Dr. Vineeta Salvi, KEM, Mumbai
15. Dr. Satish Kumar, CCMB, Hyderabad
16. Dr. G.R. Chandak, CCMB, Hyderabad
17. Dr. Ambika Nanu, AIIMS, New Delhi
18. Dr. S.G.A. Rao, Reliance, Mumbai
Drafting Committee
1. Dr. A.N. Bhisey, CRI, Mumbai Chairman
2. Dr. U.V. Wagh, NCCS, Pune
3. Dr. D. Mohanty, IIH, Mumbai
4. Dr. P.B. Seshagiri, IISc, Bangalore
5. Dr. M.G. Deo, Moving Academy, Pune
6. Dr. V. Salvi, KEM, Mumbai
7. Dr. S.S. Agarwal, ACTREC, Mumbai
8. Dr. K. Ghosh, IIH, Mumbai
9. Dr. V. Muthuswamy, ICMR, New Delhi Member Secretary
Will proposed Food Safety Agency undo the wrongs?
Food Safety Agency is likely to be set up in India by the end of this year to set stricter standards and recall procedures after having attempted streamlining of food laws by enacting a new overarching food safety law in 2006 to create an agency along the lines of the US Food and Drug Administration. The Food Safety and Standards Bill, 2006 as passed by Parliament has been enacted from August 24. The President gave his assent to the legislation on August 23, 2006.
It is claimed that the enactment takes care of international practices in guiding and regulating persons engaged in the manufacture, marketing, processing, handling, transportation, import and sale of food. It seeks to serve the consumers’ interests through food safety systems. It sets scientific standards and transparency to meet the dynamic needs of the food trade and industry sector as also international trade practices in processed food.
The proposed Food Safety agency, envisaged in the Food Safety and Standards Act will set standards for pesticides, additives, supplements, organic food and hygiene for locally produced and imported food.
Contamination and adulteration of foods is a worrying commentary on the state of India's 100-billion-dollar food market, about a third of which is processed foods. India uses about 30,000 tons of pesticides a year, more than 60 percent of it on food crops. It is worrisome that food standards apply only when the food item is in market and not before that when they are in the agricultural field.
Most of the countries of the world, developed or developing are the members of Codex Alimentarius Commission. The Codex Commission while discussing the Strategic Framework and the Action Plan has emphasised the need to encourage developing countries to convene Codex Committee meetings periodically.
The Codex Committee on Food Hygiene (CCFH) is responsible for drafting basic provisions on food hygiene applicable to all food as well as for considering amendments if necessary pertaining to the provisions on hygiene contained in Codex Commodity Standard. The technical meeting of the CCFH is held every year. CCFH is one of the important committees whose deliberations have impact on Indian exports. It is considered useful that various segments of Trade and Industry be exposed to its deliberations. In view of this, the Ministry of Health & Family Welfare organised the 39th Session of the Codex Committee on Food Hygiene from 30th October – 4th November 2007.
Panabaka Lakshmi, Minister of State for Health & Family Welfare opined that food safety legislation alone is not enough to maintain a high quality of food hygiene. It must be complemented by efforts to improve the overall standard of education among consumers. This is a fundamental area where progress could easily be made by teaching basic food hygiene in schools and through the media.
Following the recommendations of an ad hoc panel chaired by India, the 39th session of the Codex Committee on Food Hygiene (CCFH), has agreed to take up the new work on the code of hygienic practices for fresh fruits and vegetables. The CCFH agreed that the US should take the initiative and set up an electronic working group for receiving comments and suggestions. The electronic working group would be open to all interested parties.
The 40th session of CCFH is scheduled to take place in the US in December 1-5, 2008. Guatemala, which expressed its desire to co-host the meeting, has been told to take up the issue with the US Codex Secretariat.
On the issue, the use of lifting the restrictions on the use of lactoperoxidase system (LPS) for milk and milk products in global trade, the 39th CCFH decided to refer the issue to the Codex Alimentarius Commission to clarify and explain that "restriction of the use of the LPS for milk in global trade in no way precluded the use of the system by countries at the national level."
The 39th CCFH also decided to work on proposed guidelines for control of Campylobacter and Salmonella spp in broiler (young birds), chicken meat, meat carcass, and portions. CCFH will also coordinate with the world organisation for animal health - OIE - which is working on the issue at the primary level. The FAO has also drafted a document on good practices for poultry. The CCFH has decided to finalise the proposed guidelines on basis of the code of hygienic practices for meat (CAC/RCP 58-2005) and where specific information on Campylobacter and Salmonella in birds other than broilers was lacking.
It was decided that "since the structure of the microbiological risk management metrics annex had substantially changed, there was no longer any need to develop an annex to the code of hygienic practices on liquid eggs."
The 39th CCFH noted the need to provide a more detailed scientific approach for the proposed draft on Listeria Monocytogenes in ready-to-eat foods. It deliberated on the proposed drafts on hygienic practices for powdered formula for infant and young children, validation of food safety control measures, conduct of microbiological risk management, and metrics.
The CCFH meeting was attended by Naresh Dayal, Secretary, Ministry of Health & Family Welfare, Debasish Panda, Joint Secretary, Ministry of Health & Family Welfare and Co-chairperson, Codex Committee on Food Hygiene, officials from the Ministry of Health & Family Welfare and representatives of WHO and FAO. Nearly 200 delegates from all over the world, both developing and developed countries participated in it.
The Codex Alimentarius Commission (CAC) was created in 1961/62 by Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO), to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme. The main purpose of this Programme is to protect the health of consumers, ensure fair practices in the food trade, and promote coordination of all food standards work undertaken by international governmental and non-governmental organizations.
"Codex India" the National Codex Contact Point (NCCP) for India, is located at the Directorate General Of Health Services, Ministry of Health and Family Welfare (MOH&FW), Government of India. It coordinates and promotes Codex activities in India in association with the National Codex Committee and facilitates India's input to the work of Codex through an established consultation process.
It is claimed that the enactment takes care of international practices in guiding and regulating persons engaged in the manufacture, marketing, processing, handling, transportation, import and sale of food. It seeks to serve the consumers’ interests through food safety systems. It sets scientific standards and transparency to meet the dynamic needs of the food trade and industry sector as also international trade practices in processed food.
The proposed Food Safety agency, envisaged in the Food Safety and Standards Act will set standards for pesticides, additives, supplements, organic food and hygiene for locally produced and imported food.
Contamination and adulteration of foods is a worrying commentary on the state of India's 100-billion-dollar food market, about a third of which is processed foods. India uses about 30,000 tons of pesticides a year, more than 60 percent of it on food crops. It is worrisome that food standards apply only when the food item is in market and not before that when they are in the agricultural field.
Most of the countries of the world, developed or developing are the members of Codex Alimentarius Commission. The Codex Commission while discussing the Strategic Framework and the Action Plan has emphasised the need to encourage developing countries to convene Codex Committee meetings periodically.
The Codex Committee on Food Hygiene (CCFH) is responsible for drafting basic provisions on food hygiene applicable to all food as well as for considering amendments if necessary pertaining to the provisions on hygiene contained in Codex Commodity Standard. The technical meeting of the CCFH is held every year. CCFH is one of the important committees whose deliberations have impact on Indian exports. It is considered useful that various segments of Trade and Industry be exposed to its deliberations. In view of this, the Ministry of Health & Family Welfare organised the 39th Session of the Codex Committee on Food Hygiene from 30th October – 4th November 2007.
Panabaka Lakshmi, Minister of State for Health & Family Welfare opined that food safety legislation alone is not enough to maintain a high quality of food hygiene. It must be complemented by efforts to improve the overall standard of education among consumers. This is a fundamental area where progress could easily be made by teaching basic food hygiene in schools and through the media.
Following the recommendations of an ad hoc panel chaired by India, the 39th session of the Codex Committee on Food Hygiene (CCFH), has agreed to take up the new work on the code of hygienic practices for fresh fruits and vegetables. The CCFH agreed that the US should take the initiative and set up an electronic working group for receiving comments and suggestions. The electronic working group would be open to all interested parties.
The 40th session of CCFH is scheduled to take place in the US in December 1-5, 2008. Guatemala, which expressed its desire to co-host the meeting, has been told to take up the issue with the US Codex Secretariat.
On the issue, the use of lifting the restrictions on the use of lactoperoxidase system (LPS) for milk and milk products in global trade, the 39th CCFH decided to refer the issue to the Codex Alimentarius Commission to clarify and explain that "restriction of the use of the LPS for milk in global trade in no way precluded the use of the system by countries at the national level."
The 39th CCFH also decided to work on proposed guidelines for control of Campylobacter and Salmonella spp in broiler (young birds), chicken meat, meat carcass, and portions. CCFH will also coordinate with the world organisation for animal health - OIE - which is working on the issue at the primary level. The FAO has also drafted a document on good practices for poultry. The CCFH has decided to finalise the proposed guidelines on basis of the code of hygienic practices for meat (CAC/RCP 58-2005) and where specific information on Campylobacter and Salmonella in birds other than broilers was lacking.
It was decided that "since the structure of the microbiological risk management metrics annex had substantially changed, there was no longer any need to develop an annex to the code of hygienic practices on liquid eggs."
The 39th CCFH noted the need to provide a more detailed scientific approach for the proposed draft on Listeria Monocytogenes in ready-to-eat foods. It deliberated on the proposed drafts on hygienic practices for powdered formula for infant and young children, validation of food safety control measures, conduct of microbiological risk management, and metrics.
The CCFH meeting was attended by Naresh Dayal, Secretary, Ministry of Health & Family Welfare, Debasish Panda, Joint Secretary, Ministry of Health & Family Welfare and Co-chairperson, Codex Committee on Food Hygiene, officials from the Ministry of Health & Family Welfare and representatives of WHO and FAO. Nearly 200 delegates from all over the world, both developing and developed countries participated in it.
The Codex Alimentarius Commission (CAC) was created in 1961/62 by Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO), to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme. The main purpose of this Programme is to protect the health of consumers, ensure fair practices in the food trade, and promote coordination of all food standards work undertaken by international governmental and non-governmental organizations.
"Codex India" the National Codex Contact Point (NCCP) for India, is located at the Directorate General Of Health Services, Ministry of Health and Family Welfare (MOH&FW), Government of India. It coordinates and promotes Codex activities in India in association with the National Codex Committee and facilitates India's input to the work of Codex through an established consultation process.
Thursday, November 08, 2007
Sustainability of Malaria Control efforts through Chemicals
The annual incidence of malaria was estimated at around 75 million cases in 1953 with about 8 lakhs deaths annually. To combat this menace, the Government of India launched the National Malaria Control Programme in April 1953.
It proved highly successful and within five years the incidence dropped to 2 million.
The programme was changed to a more ambitious National Malaria Eradication Programme in 1958.
By 1961 the incidence dropped to a mere 50,00 cases a year. But since then the programme suffered repeated set-backs due to technical, operational and administrative reasons and the cases started rising again.
Malaria has now staged a dramatic comeback in India after its near eradication in the early and mid sixties.
During the period of resurgence of malaria, certain states like Uttar Pradesh, Bihar, Karnataka, Orissa, Rajasthan, Madhya Pradesh and Pondichery are found to be worst affected, particularly with increasing incidence of P. falciparum infection.
National Malaria Eradication Programme has been now renamed as National Anti Malaria Programme.
Malaria is an infectious disease caused by the parasite called Plasmodia. There are four identified species of this parasite causing human malaria, namely, Plasmodium vivax, P. falciparum, P. ovale and P. malariae. It is transmitted by the female anopheles mosquito. It is a disease that can be treated in just 48 hours, yet it can cause fatal complications if the diagnosis and treatment are delayed.
* Malaria affects more than 2400 million people, over 40% of the world's population, in more than 100 countries in the tropics from South America to the Indian peninsula. The tropics provide ideal breeding and living conditions for the anopheles mosquito, and hence this distribution.
* Every year 300 million to 500 million people suffer from this disease (90% of them in sub-Saharan Africa, two thirds of the remaining cases occur in six countries- India, Brazil, Sri Lanka, Vietnam, Colombia and Solomon Islands).
* WHO forecasts a 16% growth in malaria cases annually.
* About 1.5 million to 3 million people die of malaria every year (85% of these occur in Africa), accounting for about 4-5% of all fatalities in the world.
* One child dies of malaria somewhere in Africa every 20 sec., and there is one malarial death every 12 sec somewhere in the world.
* Malaria kills in 1 year what AIDS killed in 5 years. In 15 years, if 5 million have died of AIDS, 50 million have died of malaria.
* Malaria ranks third among the major infectious diseases in causing deaths- after pneumococcal acute respiratory infections and tuberculosis. It is expected that by the turn of the century malaria would be the number one infectious killer disease in the world.
* It accounts for 2.6 percent of the total disease burden of the world. It is responsible for the loss of more than 35 million disability-adjusted life-years each year.
* Every year ~ 30000 visitors to endemic areas develop malaria and 1% of them may die.
* Estimated global annual cost (in 1995) for malaria: US$ 2 billion (direct and indirect costs, including loss of labour).
* Estimated worldwide expenditure on malaria research: US$ 58 million, one thousandth of the US$ 56 billion spent globally on health research annually.
* Estimated annual expenditure on malaria research, prevention and treatment: $ 84 million.
* Estimated worldwide expenditure per malaria fatality: $ 65; as compared to $ 3274 for HIV/AIDS and $ 789 for asthma. That is to say, one HIV/AIDS death is equal to about 50 malaria deaths!
Malaria was nearly eradicated from most parts of the world by the early 60's, owing largely to concerted anti malarial campaigns world over under the guidance of the World Health Organization.
The following are some of the reasons for the resurgence of malaria:
Man made Complacency and laxity in anti malarial campaigns; conflicts and wars; migrations; deteriorating health systems; poverty
Parasite Drug Resistance
Vector Insecticide Resistance and ? ban on DDT
Environment Global Warming - increased breeding and life span of the insect vector
Jet Age Shrinking World - spread of malaria from endemic areas to all other parts of the world
1. Which chemicals are used to prevent Dengue-Malaraia? How they are harming environment and human being ?
Answer: Chemical Control measures for malaria prevention include use of Indoor Residual Spray with insecticides recommended under the programnme, use of chemical larvicides like Abate in potable water, aerosol space spray during day time and Malathion fogging during outbreaks. Although banned in developed countries, DDT is still being used in some developing countries to control malaria, but the debate is continuing.
Chemical control measures for Dengue prevention include larvicides, adulticides like Temephos (larvicides), an organophosphate, Pyrethrum (adulticide) and Malathion (adulticide) are used.
DDT residues remain in topsoil up to 7-8 cm and being immobile rarely contaminates ground water. Half-life of DDT residues in temperate soil is estimated to be 2-15 yr as against 6-14 months in tropical and subtropical soils. Similar is the case with other chemicals that enter our food chain.
DDT causes chronic liver damage cirrhosis and chronic hepatitis, endocrine and reproductive disorders, immuno suppression, cytogenic effects, breast cancer, Non hodkins lymphoma, polyneuritis.
Malathion and its oxygen analog malaoxon are both quite carcinogenic and have been linked with increased incidence of leukemia in mammals. Chronic health effects include: suspected mutagen and teratogen, delayed neurotoxin, allergic reactions, behavioral effects, ulcers, eye damage, abnormal brain waves and immuno-suppression. Contrary to what the public is being told by the Agriculture Industry and some governmental agencies, scientists are stating that Malathion (even at low levels) is in fact, a harmful chemical.
Chlorpyrifos is also used against mosquitoes. It has chronic neurobehavioral effects like persistent headaches, blurred vision, unusual fatigue or muscle weakness, and problems with mental function including memory, concentration, depression, and irritability.
Fenitrothion used against domestic insects and mosquitoes Human epidemiological evidence indicates fenitrothion causes eye effects such as retinal degeneration and myopia. Chronic exposure to Fenitrothion can cause frontal lobe impairment. Organo-phosphates are suspected of causing neurologic deficits.
2. What can substitute these chemicals ?
Answer: Biological Control measures for Malaria include use of larvivorous fish in ornamental tanks, fountains etc. and use of biocides.
Biological Control for Dengue includes use of larvivorous fish are recommended for control of Ae. aegypti in large water bodies or large water containers and Endotoxin-producing bacteria, Bacillus thuringiensis serotype H-14 (Bt H-14) has been found an effective mosquito control agent.
It is noteworthy that more effective and safer approaches to malaria control are now being used in many countries. For example, Vietnam reduced malaria deaths by 97% and malaria cases by 59% when they switched in 1991 from trying to eradicate malaria using DDT to a DDT-free malaria control program involving distribution of drugs and mosquito nets and widespread health education organized with village leaders. Mexico phased out DDT use in 2000 and implemented a successful integrated and community-based approach.
3. A number of people lost their lives due to this. why government is not banning the use of these chemicals?
The restriction permits indoor residual sprays of DDT in malaria control as per the WHO specifications for its production and following safety precautions for its proper use and disposal. Phasing out of DDT is delayed till an effective, affordable and safe alternative is available. In such a backdrop, the strong recommendation of WHO for indoor use of DDT to fight against malaria in September, 2006 that gave a clean bill to use of DDT to combat malaria where he vectors are still susceptible to DDT is believed to be the result of corporate influence especially from the pesticide industry.
The traditonal malaria control strategy has been the spraying of insecticides. Spraying of insecticides (DDT, HCH, Malathion)
As to Malathion, there are two types of malathion that can be used in medical health effects research. One is the "purified form" (which is approximately 99.9% malathion) and the other is called "technical grade" (which is approximately 96.5% malathion). The technical grade is approximately 10 times stronger in causing death to laboratory animals.
Perhaps the most sensitive of all forms of wildlife to exposure to malathion are the "dwarf lizards." These reptiles perform a service consuming significant amounts of other small insects. Lizards were exposed to malathion at levels of only 1 milligram of malathion per kilogram body weight (mg/kg) - 2 mg/kg - and 3 mg/kg. Each dosage caused significant damage to the animal's livers, kidneys, and small intestines. Note, these exposure levels are extremely small as the amount needed to cause death in most mammals is well above 500 mg/kg.
The researchers concluded by stating "Uncontrolled use of malathion or related compounds will certainly endanger not only the lives of lizards but also affect food chain and ecological balance of nature negatively."
The currently used pesticides globally cause about 20,000 deaths annually by accidental and deliberate/intentional poisoning. Unsafe spraying practices, hazardous transport, lack of storage, leakage to agriculture and poor disposal of waste etc. are major unaddressed issues.
4. what are environmentalist doing against this ?
As a result of the campaign by environmentalists, India is a signatory to Stockholm Convention on persistent organic pollutants (POPs) that has identified DDT as one of the 12 POPs that are banned. But DDT ban has certain restrictions applicable to countries for its continued use. the ban exempts its use in public health emergencies like outbreaks of malaria.
Environmentalists are arguing with the policymakers saying that resurgence of malaria calls for paradigm shift from the insecticidal to the ecological approach such as free or low-cost access to neem oil. Research shows that the natural pesticide "pyrethrum" has characteristics which make it especially effective for eliminating biting mosquitoes without harming the environment or public health.
It proved highly successful and within five years the incidence dropped to 2 million.
The programme was changed to a more ambitious National Malaria Eradication Programme in 1958.
By 1961 the incidence dropped to a mere 50,00 cases a year. But since then the programme suffered repeated set-backs due to technical, operational and administrative reasons and the cases started rising again.
Malaria has now staged a dramatic comeback in India after its near eradication in the early and mid sixties.
During the period of resurgence of malaria, certain states like Uttar Pradesh, Bihar, Karnataka, Orissa, Rajasthan, Madhya Pradesh and Pondichery are found to be worst affected, particularly with increasing incidence of P. falciparum infection.
National Malaria Eradication Programme has been now renamed as National Anti Malaria Programme.
Malaria is an infectious disease caused by the parasite called Plasmodia. There are four identified species of this parasite causing human malaria, namely, Plasmodium vivax, P. falciparum, P. ovale and P. malariae. It is transmitted by the female anopheles mosquito. It is a disease that can be treated in just 48 hours, yet it can cause fatal complications if the diagnosis and treatment are delayed.
* Malaria affects more than 2400 million people, over 40% of the world's population, in more than 100 countries in the tropics from South America to the Indian peninsula. The tropics provide ideal breeding and living conditions for the anopheles mosquito, and hence this distribution.
* Every year 300 million to 500 million people suffer from this disease (90% of them in sub-Saharan Africa, two thirds of the remaining cases occur in six countries- India, Brazil, Sri Lanka, Vietnam, Colombia and Solomon Islands).
* WHO forecasts a 16% growth in malaria cases annually.
* About 1.5 million to 3 million people die of malaria every year (85% of these occur in Africa), accounting for about 4-5% of all fatalities in the world.
* One child dies of malaria somewhere in Africa every 20 sec., and there is one malarial death every 12 sec somewhere in the world.
* Malaria kills in 1 year what AIDS killed in 5 years. In 15 years, if 5 million have died of AIDS, 50 million have died of malaria.
* Malaria ranks third among the major infectious diseases in causing deaths- after pneumococcal acute respiratory infections and tuberculosis. It is expected that by the turn of the century malaria would be the number one infectious killer disease in the world.
* It accounts for 2.6 percent of the total disease burden of the world. It is responsible for the loss of more than 35 million disability-adjusted life-years each year.
* Every year ~ 30000 visitors to endemic areas develop malaria and 1% of them may die.
* Estimated global annual cost (in 1995) for malaria: US$ 2 billion (direct and indirect costs, including loss of labour).
* Estimated worldwide expenditure on malaria research: US$ 58 million, one thousandth of the US$ 56 billion spent globally on health research annually.
* Estimated annual expenditure on malaria research, prevention and treatment: $ 84 million.
* Estimated worldwide expenditure per malaria fatality: $ 65; as compared to $ 3274 for HIV/AIDS and $ 789 for asthma. That is to say, one HIV/AIDS death is equal to about 50 malaria deaths!
Malaria was nearly eradicated from most parts of the world by the early 60's, owing largely to concerted anti malarial campaigns world over under the guidance of the World Health Organization.
The following are some of the reasons for the resurgence of malaria:
Man made Complacency and laxity in anti malarial campaigns; conflicts and wars; migrations; deteriorating health systems; poverty
Parasite Drug Resistance
Vector Insecticide Resistance and ? ban on DDT
Environment Global Warming - increased breeding and life span of the insect vector
Jet Age Shrinking World - spread of malaria from endemic areas to all other parts of the world
1. Which chemicals are used to prevent Dengue-Malaraia? How they are harming environment and human being ?
Answer: Chemical Control measures for malaria prevention include use of Indoor Residual Spray with insecticides recommended under the programnme, use of chemical larvicides like Abate in potable water, aerosol space spray during day time and Malathion fogging during outbreaks. Although banned in developed countries, DDT is still being used in some developing countries to control malaria, but the debate is continuing.
Chemical control measures for Dengue prevention include larvicides, adulticides like Temephos (larvicides), an organophosphate, Pyrethrum (adulticide) and Malathion (adulticide) are used.
DDT residues remain in topsoil up to 7-8 cm and being immobile rarely contaminates ground water. Half-life of DDT residues in temperate soil is estimated to be 2-15 yr as against 6-14 months in tropical and subtropical soils. Similar is the case with other chemicals that enter our food chain.
DDT causes chronic liver damage cirrhosis and chronic hepatitis, endocrine and reproductive disorders, immuno suppression, cytogenic effects, breast cancer, Non hodkins lymphoma, polyneuritis.
Malathion and its oxygen analog malaoxon are both quite carcinogenic and have been linked with increased incidence of leukemia in mammals. Chronic health effects include: suspected mutagen and teratogen, delayed neurotoxin, allergic reactions, behavioral effects, ulcers, eye damage, abnormal brain waves and immuno-suppression. Contrary to what the public is being told by the Agriculture Industry and some governmental agencies, scientists are stating that Malathion (even at low levels) is in fact, a harmful chemical.
Chlorpyrifos is also used against mosquitoes. It has chronic neurobehavioral effects like persistent headaches, blurred vision, unusual fatigue or muscle weakness, and problems with mental function including memory, concentration, depression, and irritability.
Fenitrothion used against domestic insects and mosquitoes Human epidemiological evidence indicates fenitrothion causes eye effects such as retinal degeneration and myopia. Chronic exposure to Fenitrothion can cause frontal lobe impairment. Organo-phosphates are suspected of causing neurologic deficits.
2. What can substitute these chemicals ?
Answer: Biological Control measures for Malaria include use of larvivorous fish in ornamental tanks, fountains etc. and use of biocides.
Biological Control for Dengue includes use of larvivorous fish are recommended for control of Ae. aegypti in large water bodies or large water containers and Endotoxin-producing bacteria, Bacillus thuringiensis serotype H-14 (Bt H-14) has been found an effective mosquito control agent.
It is noteworthy that more effective and safer approaches to malaria control are now being used in many countries. For example, Vietnam reduced malaria deaths by 97% and malaria cases by 59% when they switched in 1991 from trying to eradicate malaria using DDT to a DDT-free malaria control program involving distribution of drugs and mosquito nets and widespread health education organized with village leaders. Mexico phased out DDT use in 2000 and implemented a successful integrated and community-based approach.
3. A number of people lost their lives due to this. why government is not banning the use of these chemicals?
The restriction permits indoor residual sprays of DDT in malaria control as per the WHO specifications for its production and following safety precautions for its proper use and disposal. Phasing out of DDT is delayed till an effective, affordable and safe alternative is available. In such a backdrop, the strong recommendation of WHO for indoor use of DDT to fight against malaria in September, 2006 that gave a clean bill to use of DDT to combat malaria where he vectors are still susceptible to DDT is believed to be the result of corporate influence especially from the pesticide industry.
The traditonal malaria control strategy has been the spraying of insecticides. Spraying of insecticides (DDT, HCH, Malathion)
As to Malathion, there are two types of malathion that can be used in medical health effects research. One is the "purified form" (which is approximately 99.9% malathion) and the other is called "technical grade" (which is approximately 96.5% malathion). The technical grade is approximately 10 times stronger in causing death to laboratory animals.
Perhaps the most sensitive of all forms of wildlife to exposure to malathion are the "dwarf lizards." These reptiles perform a service consuming significant amounts of other small insects. Lizards were exposed to malathion at levels of only 1 milligram of malathion per kilogram body weight (mg/kg) - 2 mg/kg - and 3 mg/kg. Each dosage caused significant damage to the animal's livers, kidneys, and small intestines. Note, these exposure levels are extremely small as the amount needed to cause death in most mammals is well above 500 mg/kg.
The researchers concluded by stating "Uncontrolled use of malathion or related compounds will certainly endanger not only the lives of lizards but also affect food chain and ecological balance of nature negatively."
The currently used pesticides globally cause about 20,000 deaths annually by accidental and deliberate/intentional poisoning. Unsafe spraying practices, hazardous transport, lack of storage, leakage to agriculture and poor disposal of waste etc. are major unaddressed issues.
4. what are environmentalist doing against this ?
As a result of the campaign by environmentalists, India is a signatory to Stockholm Convention on persistent organic pollutants (POPs) that has identified DDT as one of the 12 POPs that are banned. But DDT ban has certain restrictions applicable to countries for its continued use. the ban exempts its use in public health emergencies like outbreaks of malaria.
Environmentalists are arguing with the policymakers saying that resurgence of malaria calls for paradigm shift from the insecticidal to the ecological approach such as free or low-cost access to neem oil. Research shows that the natural pesticide "pyrethrum" has characteristics which make it especially effective for eliminating biting mosquitoes without harming the environment or public health.
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