Friday, November 16, 2007

Medicine prices up by 10%

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

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 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

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.

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

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.

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.

Wednesday, October 31, 2007

Beware of Fifth Columnists !

Beware of Fifth Columnists (Mir Zafars, Jai Chands)!

We are witnessing verbal gymnastics in full swing in the JNU campus as elsewhere. While observing different point of views of various outfits, one is concerned over the attempts of some outfits to ‘mis-diagnose’ the reasons of ill-health and health inequality in India. Why no one has raised this issue so far?

The propaganda, while putting the blame on politicians, takes pain to glorify (a) the role of “western medicine and a status quoist profession of doctors”, (b) the charitable “medical camp approach” and (c) to self-perpetuate its own tribe. Irrespective of the political ilk of these outfits, the fact that they are an outcome of promoters of corporate interest that legitimizes contract system for workers is revealing enough. These outfits end up supporting the main beneficiaries (and exploiters) and ignore the mushrooming of exploitative clinics in cities at the cost of both the urban poor and the rural poor. Don’t we know who these collaborators are who end up supporting contract work regime?

The nexus between medical professionals and pharma companies is an established fact. What is worse is that both the urban poor and rural poor are being administered outdated, harmful, banned and spurious drugs. India remains one among the few third world countries that connives at the ongoing inhuman practice of guinea pig medical experiments on poor people for foreign firms. Do the outfits have remedy for this menace?

The damaging impact of these male dominated professionals on ill heath and health inequality in India is well documented in academic literature. There is a promise of working for Health for all. While the promise of universal health care is worth struggling for, it gives a sense of déjà vu. Didn’t the National Health Policy, 1983 had this as its target? After failing to meet the target, instead of working towards overcoming the admitted failure, the National Health Policy 2002 changed the target. Is there any reason to believe that the outfits who make this promise will not do the same?

While the aim for 24 X 7 medical facilities is understandable, their use of medical facility as the route for achieving health for all is deceptive. Is “medical facility” and “health for all” one and the same?

Some of these outfits are glaringly one dimensional with their obsession with single issue. Far-reaching structural changes in the land-tenurial system and institutional reforms for the educational and economic upliftment of the weaker sections of society are required but these outfits have not even taken note of it. Is sloganeering sufficient to bring equality even as the country is getting infested with at least 36 billionaires whose combined wealth is one-fourth of India’s GDP? All contemplative minds must remain ever vigilant about the various shapes and sizes of the fifth columnists in the campus and even in their own outfits.

-public interest release
(Gopal Krishna, 47 Brahmaputra and M. Kumaran, 163 Tapti)

Friday, October 26, 2007

new anti-pregnancy vaccine not a magic solution

Note: "There is an urgent need for health and family welfare services as acknowledged by the National Population Policy of 2000. Without meeting this existing need, to think of magic bullets is absurd. What we need is safe, effective, user-friendly and user-controlled contraception and not something which has huge potential for misuse in India's target-driven family planning programme."

-- Mohan Rao, professor, Centre for Social Medicine and Community Health, Jawaharlal Nehru University and member of the National Population Commission in Outlook, October 29, 2007

Immaculate Injection?

A new anti-pregnancy vaccine may yet be a trusted contraceptive

* Clinical trials in the early 1990s led to protests from women's groups. The project was shelved.
* Revived after a genetically modified antigen was developed last year
* The vaccine generates antibodies that do not allow the uterus to be readied for the embryo
* Critics say focus should be on safer and user-controlled contraceptions like condoms
* The vaccine does not protect against sexually transmitted diseases

It was a pathbreaking medical project that once fell victim to its own side-effects: coming in the form of ethical doubts and partisan ire. Now, clinical tests of one of India's most ambitious and controversial vaccines to prevent pregnancy have been relaunched, with the Indian Council of Medical Research expressing interest in a new version of the vaccine. Currently, it is being tested on mice and will later be tested on women volunteers. Work on the first form of the vaccine was shelved over a decade ago because of limited success. The clinical trials in Delhi and Chandigarh had also come in for sharp criticism from women activists who alleged that those tested were not informed volunteers and that the vaccine had possible side-effects.

But it has now been revived after a genetically engineered version of the human chorionic gonadotropin (HCG) vaccine was developed last April by G.P. Talwar, director of the New Delhi-based Talwar Research Foundation. A former director of the National Institute of Immunology (NII), Talwar conceived of such a vaccine in the late 1970s and worked on it through the '80s and early '90s.

About a month back, an ICMR task force met to study the data produced by Talwar and his team from tests conducted on mice at NII. "The data showed that all the mice administered with the vaccine had produced promising levels of antibodies. We have now asked Talwar to generate more data using mice of different genetic backgrounds," Indira Nath, chairman of the ICMR task force, told Outlook.

The project also got a boost following Manmohan Singh's visit to the US in March 2005, when an Indo-American forum on contraception expressed its interest. "I had forgotten about this project," admits Talwar. "Then the Americans came asking about its progress, claiming even women there wanted such a vaccine." The project is now being supported by the central government's department of biotechnology.

The vaccine works by generating antibodies that neutralise HCG, a hormone secreted by pregnant women. HCG plays a critical role in ensuring pregnancy, as it readies the uterus for the embryo to be implanted. Devoid of the hormone, the uterus rejects the embryo, thus preventing pregnancy. However, this effect is reversible because the antibodies generated by a single dose of the vaccine lose their effect over time and allow the HCG hormone to resume its normal function. A woman who wishes to remain immune to pregnancy for longer periods would therefore need to take booster doses.

The current form of the vaccine differs from its older version in that it uses genetically engineered HCG unlike the earlier version, which used HCG purified from the urine of pregnant women. The HCG is fused with alien substances (like tetanus toxoid) that alter its properties and also act as carriers, provoking the body to create antibodies to HCG.

"The vaccine can now be industrially produced and at much cheaper rates than it could be with the earlier form," Talwar says. The vaccine in its present form will also have to be injected, but work is on to develop an alternative which can be orally consumed.

But before the vaccine reaches the market, like all drugs and vaccines, it too will have to clear several efficacy and toxicology tests.It will also have to be tested on women. Talwar declined to set a deadline to his project. "Why should I? No scientist can say when his work is going to end till it actually ends. All I can say at this stage is that the vaccine is on its way and that the progress is encouraging." This vaccine, if released to the public successfully, may have a lasting impact on the market for contraceptives.

Women at a family planning centre

But not everyone is as enthusiastic about the vaccine as Talwar and his colleagues. Notes N.B. Sarojini, a health activist with Sama, a Delhi-based women's health group that is opposed to the project: "Vaccines are supposed to fight infectious diseases, not pregnancy, which is a normal function of the human body. It may also cause auto-immune disorders, like allergies or hypersensitivity. It also does not offer protection against sexually transmitted diseases."

Incidentally, the earlier form of the vaccine had its limitations since only 60 to 80 per cent of the women generated the required level of antibodies (50 nanogram/ml of blood) to prevent pregnancy. Moreover, human trials of the vaccine, conducted in aiims and Safdarjung Hospital in New Delhi and pgimer in Chandigarh, generated controversy. Talwar and his team were accused of not taking informed consent from the participants and experimenting on lactating women. Talwar says this in his defence: "These accusations have no scientific basis. Why would I use lactating women in any case? The protocol never stated we would test it on them because they do not have menstrual cycles and are naturally protected from pregnancy. As for informed consent, the whole protocol was approved by the drug controller and trials carried out in reputed institutions. And for those who would still like to see, the records are available with NII."

Talwar says the vaccine offers an "ideal" family planning tool compared to those currently in use. "People often opt for surgery (vasectomy or tubectomy) at a late stage in life after having many children. Again, intra-uterine devices often cause bleeding and that is unhealthy because most women in the country are already on the margin of anaemia. And as for steroid-based contraceptives, they stop a woman from ovulating normally," he points out. According to him, the HCG vaccine's effect can be reversed, it does not harm the normal physiology of a woman and does not demand a day-to-day intake.

However, the very search for a 'magic solution' has its critics. Says Mohan Rao, professor at Jawaharlal Nehru University's Centre for Social Medicine and Community Health and member of the National Population Commission: "There is an urgent need for health and family welfare services as acknowledged by the National Population Policy of 2000. Without meeting this existing need, to think of magic bullets is absurd. What we need is safe, effective, user-friendly and user-controlled contraception and not something which has huge potential for misuse in India's target-driven family planning programme." Clearly, from conception to consensus, the vaccine has some distance to travel.

Outlook, October 29, 2007

Saturday, October 20, 2007

National Family Health Survey - III Released

More than half the women in the country are anaemic and one in three child is underweight.

"Anaemia is disturbingly common among adults. 55 percent of women in India are anaemic and 43 percent of kids below the age of three are underweight," reveals the final report of the National Family Health Survey - III (NFHS-3), released on 11th October.

The 2005-06 National Family Health Survey (NFHS-3) is the third in a series of national surveys; earlier NFHS surveys were carried out in 1992-93 (NFHS-1) and 1998-99 (NFHS-2).

Anaemia among pregnant women during that period has also increased. Even though men are much less likely than women to be anaemic, anaemia levels in men are at around 24 percent," the NFHS survey revealed.

The findings showed that malnutrition continues to be a significant health problem for children and adults in India.

"There has been very marginal change in the percentage of children who are underweight. From 43 percent underweight children in 1998-99 to 40 percent in 2006."

NFHS-3 also found high prevalence of anaemia - 70 percent in children aged 6-59 months. Anaemia is primarily linked to poor nutrition.

"Women and men suffer a dual burden of over nutrition and under nutrition. More than one third of women are too thin, while 13 percent are overweight.

"One-third of men are too thin, and 9 percent are overweight or obese. The states with the largest percentage of overweight women and men are in Punjab, Kerala, and Delhi, especially among the more educated," the survey pointed out.

All three NFHS surveys were conducted under the stewardship of the Ministry of Health and Family Welfare, Government of India, with the International Institute for Population Sciences, Mumbai, serving as the nodal agency. ORC Macro, Calverton, Maryland, USA, provided technical assistance for all three NFHS surveys. NFHS-1 and NFHS-2 were funded by the United States Agency for International Development, with supplemental funding from UNICEF.

NFHS-3 funding was provided by the United States Agency for International Development, the Department for International Development (United Kingdom), the Bill and Melinda Gates Foundation, UNICEF, the United Nations Population Fund, and the Government of India. Assistance for the HIV component of the NFHS-3 survey was provided by the National AIDS Control Organisation and the National AIDS Research Institute.

In NFHS-3, 18 research organisations conducted interviews with more than 230,000 women age 15-49 and men age 15-54 throughout India. NFHS-3 also tested more than 100,000 women and men for HIV and more than 200,000 adults and young children for anaemia. Fieldwork for NFHS-3 was conducted from December 2005 to August 2006.

Wednesday, October 17, 2007

Setting a precedent for trafficking hazardous waste

By every rule in the book, this ship, carrying asbestos waste and radioactive elements, should not be in Indian waters, let alone be beached. And yet, despite well-premised objections, the central government persuaded the Supreme Court to rule that Blue Lady be dismantled at Alang.

On 6 September and 11 September, two related judgments in the matter of shipbreaking and hazardous waste were issued by the Supreme Court of India. The Division Bench of Justice Dr Arijit Pasayat and Justice S H Kapadia delivered both the orders. This was the same Bench that was seized with the Le Clemenceau case. The first order is a general order on the issue of ship-breaking. The second order was with specific reference to status of the Blue Lady (formerly SS Norway) -- a ship with known dangers: asbestos and radioactive material, and without clear papers -- currently beached at the Alang shipyard in Gujarat. This order gave a go ahead to dismantling of the Blue Lady.

Dismantling the Blue Lady exposes the mostly Bhojpuri and Oriya speaking causal and migrant workers and the villagers of Bhavnagar panchayats near Alang to toxic exposures. It also threatens their source of livelihood -- fishing due -- to marine pollution. By the government's own admission - a report of technical experts on shipbreaking -- the underground water in Alang is heavily polluted. The ship-breaking industry is already known to have a higher accident rate (2 workers per 1000) than the mining industry (0.34 per 1000). This is considered the worst in the world, and 16 per cent of workers here are suffering asbestos related diseases.

In its order on 11 September, the Honourable Supreme Court advanced "The concept of "balance" under the principle of proportionality applicable in the case of sustainable development…" and ruled that: "It cannot be disputed that no development is possible without some adverse effect on the ecology and environment, and the projects of public utility cannot be abandoned and it is necessary to adjust the interest of the people as well as the necessity to maintain the environment. A balance has to be struck between the two interests. Where the commercial venture or enterprise would bring in results which are far more useful for the people, difficulty of a small number of people has to be bypassed. The comparative hardships have to be balanced and the convenience and benefit to a larger section of the people has to get primacy over comparatively lesser hardship."

The apex court ruled this way even though it also did not dispute that the entry of Blue Lady in Indian territorial waters and its continued presence since June 2006 was itself in violation of court's own order of 14 October 2003. It was also in violation of the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal, and a number of other international environmental and labour conventions and treaties -- that govern the breaking of contaminated ships - to all of which India is a signatory.

In the 11 September order, the honourable justices refer to former the Attorney General of UK saying, "In his Keynote Address, on 'Global Constitutionalism', reported in Stanford Law Review vol. 59 at p. 1155, Lord Goldsmith, Her Majesty's Attorney General (UK), stated that British Constitution though unwritten is based on three principles, namely, rule of law, commitment to fundamental freedoms and principle of proportionality. European Convention on Human Rights ("ECHR") also refers to the concept of balance."

The 21-page keynote address of Lord Goldsmith has this paragraph that has been referred to in the apex court's order. It reads as follows: "The third principle is that of proportionality. One of the key themes of the ECHR is the concept of balance. The Convention took its lead in this respect from the Universal Declaration of Human Rights-and in particular, article 29 which expressly recognises the duties of everyone to the community and the limitation on rights in order to secure and protect respect for the rights of others. Under the Convention some rights are absolute. They are so fundamental that there can be no compromise on them. We take the view that the prohibition on torture is simply nonnegotiable. I regard the right to a fair trial as another of those fundamentals. That is why we have rejected reducing the burden of proof for terrorism offences and allowing secret evidence in terrorism trials."

It is shocking to note that Goldsmith's speech in question does not appear at all to be relevant to the plight of workers, villagers, environment, ship-breaking industry, steel or hazardous wastes management. Therefore, it cannot be a convincing rationale for knowingly letting a most vulnerable workforce and communities suffer from asbestos and radioactive exposure that will arise from breaking up the Blue Lady.

Verified threat of hazardous waste on-board - radioactive elements

The bench granted permission for the dismantling based on the submission by Gopal Subramaniam, the Additional Solicitor General, to the effect that the ship does not have any more radioactive material and beaching is irreversible. But contrary to the recommendations of the Technical Experts Committee on Hazardous Wastes relating to Ship-breaking, Gujarat Pollution Control Board, Gujarat Enviro Protection and Infrastructure Ltd, (GEPIL) and the ship's current owner Priya Blue Shipping Pvt Ltd., the ship does contain radioactive substances at thousands of places.

In the order passed the apex court merely states, "There was also an apprehension rightly expressed by the petitioner regarding radioactive material on board the vessel Blue Lady. Therefore, an immediate inspection of the said vessel beached at Alang since 16.8.2006 was undertaken by Atomic Energy Regulatory Board (AERB) and by Gujarat Maritime Board (GMB). The apprehension expressed by the petitioner was right. However, as the matter stands today, AERB and GMB have certified that the said vessel Blue Lady beached in Alang no more contains any radioactive material on board the ship."

What changed?

A perusal of the report of the inspection undertaken on 14 August 2007 shows that the entire inspection of 16 floors of 315 meter long ship seems to have been completed within a period of 4 hours (a commendable task no doubt) and the report states that they could detect only 12 smoke detectors containing Americium 241. Having found these 12 smoke detectors containing radioactive materials, the report concludes that the ship "now, does not contain any radioactive material on board".

In my petition, I had referred to a letter sent by one Tom Haugen (who had been the Project Manager for Engineering, Delivery, Installation, Commissioning and later services and upgrades as regards Fire Detection Installation Systems on-board the Blue Lady). Haugen had written to Meena Gupta, Chairman of the Technical Experts Committee (by virtue of being the Secretary at the Ministry of Environment) that the fire detection system on the Blue Lady contained 5500 detection points which included 1100 ion smoke detectors that use radioactive elements composed of Americium 241. Further, in a separate letter to the Prime Minister dated 19 September 2007, Haugen has reiterated the fact about the enormity of radioactive material on the ship given that he himself supervised its installation.

Countering the AERB-GMB report that that ship did not contain any radioactive material after their inspection, Haugen wrote that in most cases, the fire detection systems are not labeled or indicated in any way, as they are typically 'buried' out of sight. According to Haugen, due to the risk of hazardous radioactive exposure, they should only be handled by professionals or certified technicians. "The system and its detectors are very subtly placed and virtually completely hidden in most parts, so it is totally understandable that a non-expert team might miss it during a broader inspection of the vessel," wrote Haugen.

In fact, even though the Technical Experts Committee had put in its 2006 report that there was no radioactive material on the ship, one of the Committee's members Dr Virendra Misra of the Industrial Toxicology Research Centre, Lucknow, had disagreed with the findings. He wrote that, "Presence of radioactive materials should be ascertained well in advance. Though it is mentioned in the report that radioactive material is not available, in my opinion there is possibility of the presence of radioactive materials due to existence of liquid level indicators and smoke detectors on the ship." This was ignored by TEC's then chairman, Prodipto Ghosh. The final report of the Technical Committee was signed by only Ghosh. All of this is in the records of the apex court.

But Additional Solicitor General Subramaniam persuaded the apex court to rely on the report of the Prodipto Ghosh-led Technical Experts Committee. (Ghosh was Secretary at the Environment Ministry and Chairman of the Committee. He has since retired, and his post has been taken over by Meena Gupta.) This is a report that had submitted that there is no radioactive material on the ship, as noted earlier. But following the submission of Tom Haugen's letter to the apex court and our request to the AERB, the AERB team inspected the ship. As noted earlier, it concluded that there are only 12 equipments that have radioactive material in it. Subramaniam was then compelled to partially admit in the hearing to the presence of radioactive material on Blue Lady. But the fact is that there are still over one thousand such equipments in the ship and Haugen has the diagram showing the locations of the equipment.

Verified threat of hazardous waste on-board – asbestos

On the asbestos present in the ship, the court also heard ingenious arguments advanced by the learned Additional Solicitor General Subramaniam that, "In the present case, the vessel does not contain single kilogram of asbestos and/or ACM as cargo". It had never been the stand of the plaintiff that asbestos or Asbestos Containing Material (ACM) was being sought to be brought in as cargo. Asbestos is already built into the ship's structure.

The question of differentiating between inbuilt material carrying asbestos and asbestos cargo had infact already been addressed by a Parliamentary Committee. The Parliamentary Committee on Petitions, on 17 August 2007, issued its report in response to the matter being raised in Lok Sabha by Basudev Acharya (CPI (M), Bankura, West Bengal). Acharya, a senior parliamentarian, had petitioned the Committee, arguing that Blue Lady's entry violates India's sovereignty. Incidentally, the Environment Ministry did give oral evidence before this Committee, but did not disclose the radioactive content of the ship.

The Parliamentary Committee, chaired by Prabhunath Singh (MP-Janata Dal (United), Maharajganj, Bihar), in its response, noted that it was extremely concerned that the ship contains an estimated 1240 MT of ACM and about 10 MT of PCBs as inbuilt material and as a part of its structure. The committee recognised that asbestos fibers when inhaled or when the PCBs on-board are consumed by human beings, the same may cause cancer unless proper precautions are taken for safe handling of these materials by the workers. The report then got into issue of asbestos in the cargo vs. structure, virtually indicting the government: "The committee strongly deprecate (sic) the repeated stand taken by the ministry that since no hazardous waste have been allowed on boards as cargo, there is no violation of the Hon'ble Supreme Court directions. The Committee need not emphasize that hazardous waste whether as cargo or inbuilt material are equally detrimental to the environment and to the human health."

Earlier Kalraj Mishra (MP-BJP, Lucknow), member of the Parliamentary Committee on Industry, had asserted that the French ship Le Clemenceau was sent back, and the Blue Lady, being 50 times more toxic than the Le Clemenceau, should therefore also be sent back.

It appears that the Supreme Court has accepted that 85 per cent of the asbestos, contained in the form of wall partitions, ceilings and the roofing in rooms and galleries in the ship, did not pose a risk if those parts were removed without damaging them. But no mention seems to have been made as regards the balance 15 per cent of the asbestos contained on the Blue Lady, which in itself would come to 186 metric tonnes. Removal of this asbestos is bound to cause grave risks of asbestosis, mesothelioma, lung cancer and other related illnesses to workers.

In my petition, I brought to the notice of the apex court that asbestos waste is banned in India and asbestos itself is banned in some 45 countries and even the World Trade Organisation had passed a verdict against it because of its carcinogenicity at every level of exposure. There is indisputable evidence that safe and controlled use of asbestos is impossible. Despite this, the Additional Solicitor General Subramaniam argued, "Safe use and controlled use of asbestos is possible in India." He said that asbestos waste in the structure of the ship was not hazardous and asserted that asbestos waste is banned in India but that applies to 'virgin' asbestos waste!

The Hon'ble Supreme Court has not yet dealt with the application filed by Bhagvatsinh Haluba Gohil, Sarpanch, Village Sosiya, Tehsil Talaja, and District Bhanvnagar on behalf of 30, 000 villagers and 12 panchayats of Bhavnagar district of Gujarat. The villages are in the vicinity of Alang ship-breaking yard. They sought directions asking the court to "direct that the ship named "Blue Lady" (SS Norway) be not allowed to be dismantled at the Alang Ship-breaking yard." The villagers have argued that "The dismantling of the ship would have hazardous effect on the residents of the villages near the Alang ship breaking yard as the ship contains large amount of asbestos which, when exposed is hazardous to the health of the residents living in the twelve villages."

In August 2006, an acclaimed scientist, a former Union Minister, Prof M G K Menon, and the Chairman of the Supreme Court's High Power Committee on Hazardous Wastes, had written to the Chief Justice of India and argued that the Blue Lady should be sent back to Malaysia or Germany from where it had come without decontamination.

Faulty argument on a beached ship not being refloatable

There's more. Allen Todd Busch, Vice President and General Manager, Titan Salvage, a Crowley Company, and one of the largest and most respected salvage companies, also wrote to the Prime Minister. He said, "The primary reason the court has ruled in favour of breaking the vessel, in its current position, is because there is a belief that the vessel can not be removed from where it now rests." Busch disagreed with that premise. He wrote that his firm had the capability and expertise to refloat the vessel. "Please allow us to present to the Prime Minister and India's Court our credentials, history and experience that there is actually very high probability that the BLUE LADY is not at all in an "irreversible" position, as the esteemed Court has found," wrote Busch. Also the firm Aaage Anderson, which was involved in the Le Clemenceau case, has said in a technical memo that the Blue Lady can be refloated.

Even as it was becoming clearer that the Blue Lady (SS Norway, SS France) can be sent back, the Additional Solicitor General Subramaniam led the court into believing that since beaching is irreversible, that the Blue Lady cannot be sent back. But the Blue Lady, as noted earlier and in previous articles, is illegal traffic as per all relevant laws. There is documentary proof that such ships are required certification for prior decontamination of the ship in the country of export. In the case of Blue Lady let alone decontaminating the ship as per the court's order, it has till date not even been claimed that it has been decontaminated.

Dangerous precedent for globalisation of waste

The list goes on and on. I had also pointed in my petition before the honourable court that the "Prior Informed Consent" convention -- which has been accepted in the Rio Declaration, Basel Convention, Cartegena Protocol, Rotterdam Convention, and the Stockholm Convention, had also been incorporated in Hazardous Wastes Rules 1989. As per this principle, no member state can send hazardous waste to a developing country without its prior consent. This has not been followed in the case of the Blue Lady. Another important convention -- that has been violated -- is that a ship ought to be decontaminated prior to its export for dismantling, which view has been expressed earlier by the apex court itself.

Dismantling of the Blue Lady would set a dangerous precedent. Hazardous and poisonous material does not become non-hazardous and non-poisonous merely because the government -- the Environment Ministry and Additional Solicitor General -- assert so. The Blue Lady story shows how hazardous industries, substances, wastes are being transferred to India in full public glare due to the connivance of Indian authorities who have compelled the highest court to decide matters on technical and humanitarian grounds (the original permission to beach the ship in 2006 was given on humanitarian grounds owing to inclement weather) rather than on a legal basis.

Even though the toxic ship Le Clemenceau was recalled in early 2006 on a verdict by a French court, the Blue Lady story only exposes the conflicted European position on ship-breaking and asbestos. Germany has condoned the Blue Lady's violation of Basel Convention - the contaminated ship left its shores in 2005 - to stay unreversed. This has in turn allowed the ship owners to successfully escape exorbitant decontamination cost in Europe.

P.S.: The recent news report suggesting that dismantling of Blue Lady has begun is far from the truth. In fact it is an effort by the cash buyers to tell the interested ship owners that things have not come to a standstill at Alang. This is to ensure the flow of obsolete ships at Alang. The ship-breakers have not even claimed that they have decontaminated the ship. It appears to be a planted story. In fact it is an effort by the cash buyers to tell the interested ship owners that things have not come to a standstill at Alang. This is to ensure the flow of obsolete ships at Alang. The reasoning presented before the court was an exercise in sophistry. If sustainable development is the reason then why do judges say “Lastly, we may point out that there is no dispute that on 15/16.8.2006 the vessel beached off Alang coast. It is not in dispute that the process of beaching is irreversible.” (Supreme Court order Para 14, 11.9.2007) Their main but insincere reasoning is that it will give jobs to 700 workers and 41, 000 tonne of steel. The real number is 300 workers. But mere 41, 000 tonne is of not at all of significance since India is the world's largest producer of direct reduced iron (DRI) or sponge iron and is the seventh largest steel producer in the world with an overall production of about 40 mt in 2006 . Three-fold rise in steel production capacity to 120 million tonne is going to make the second-largest steel producer in the world in very near future.

Dismantling plan submitted by Priya Blue Shipping Ltd to the Technical Experts Committee (TEC) is simply a paper work that has failed to inform the court as to what it would do for PCBs, incineration ash, ballast water, radioactive material, Lead and other heavy metals. Given the fact that there are casual and migrant workers, the commitment to protect workers is not at all credible. Safe handling of asbestos is not possible, it requires a Astronaut's dress that is not possible to work in any case even the TEC report has noted that these safety gears are provided to workers only when inspection team visits Alang yards. Riky, the Danish ship has been dismantled and the matter is pending before this very bench but they have decided not to hear the matter so far although it preceded the present ship but showed inexplicable exemplary speed in dealing with Blue Lady. It is quite well known that as long as Gujarat Maritime Board the supervising authority, there would be no safety for the workers and the villagers. As of 15th October, 2007, the 12 village councils (panchayat, a local governance unit) heads were deliberating over ways to protest against the court order. They have scheduled their meeting for 25th October.

Thursday, September 20, 2007

Health Promises in National Common Minumum Programme

National Health Policy 2002 admitted that as a result of
inadequate public health facilities, it has been estimated that less
than 20 percent of the population, avail of services in public hospitals. This is despite the fact that most of these patients do not have the means to make out-of-pocket payments for private health services except at the cost of other essential expenditure for items such as basic nutrition. In order to respond to this situation the United Progressive Alliance (UPA)Government led by Indian National Congress and supported by left parties formulated a National Common Minimum Programme in May 2004 and made health related promises among other things.

The promises are listed as under:

A national cooked nutritious mid-day meal scheme funded mainly by the central government, will be introduced in primary and secondary schools. An appropriate mechanism for quality checks will also set up. The UPA will also universalize the Integrated Child Development Services (ICDS) scheme to provide a functional anganwadi in every settlement and ensure full coverage for all children. The UPA government will fully back and support all NGO efforts in the area of primary education.

The UPA government will raise public spending on health to at least 2-3% of GDP over the next five years with focus on primary health care. A national scheme for health insurance for poor families will be introduced. The UPA will step up public investment in programmes to control all communicable diseases and also provide leadership to the national AIDS control effort.

The UPA government will take all steps to ensure availability of life-savings drugs at reasonable prices. Special attention will be paid to the poorer sections in the matter of health care. The feasibility of reviving public sector units set up for the manufacture of critical bulk drugs will be re-examined so as to bring down and keep a check on prices of drugs.

Saturday, September 15, 2007

Malaria, Public Health & Environment

Spraying of DDT leads to its transfer of residues through food chain resulting in its bioconcentration culminating in its biomagnifications in primary and secondary consumers including man. An editorial “Resurrection of DDT: A critical appraisal” in the July 2007 issue of Indian Journal of Medical Research suggests, “Environmentalists must reassess the situation based on data obtained after its ban in agriculture in India and elsewhere.” This journal is published by the Indian Council of Medical Research.

It further submits, “In India, at present DDT is used against malaria vectors which are susceptible to DDT as in North Eastern States and hilly regions of the country. This regulated use of DDT exclusively for public health showed gains in reduction in DDT residue levels in many items of food. Anopheles culicifacies, major vector of malaria highly resistant to DDT since 1960s, now shows increased susceptibility in Gujarat and other parts of the country where DDT was withdrawn since 1969 (unpublished). These results dispel the misinformation that DDT is no longer effective in entire India.”

Commonly known as DDT, its scientific name is 1,1,1-trichloro-2,2-bis (p-chlorophenyl) ethane was synthesized by Othmar Zeidler in 1874, came to lime light with Paul Muller’s
discovery of its insecticidal properties in 1939. It is claimed that DDT achieved a unique distinction of saving millions of lives by preventing disease outbreaks than any other man made chemical in history for which Muller was awarded the Nobel Prize for medicine in 1945.

The WHO/UNICEF Roll back malaria (RBM) initiative to reduce 50 per cent deaths by 2010 in Africa it involved use of pyrethroid treated nets, pyrethroid IRS and artemisinin. Donor nations for RBM mandated only the use of pyrethroids in place of DDT. In India, the use of DDT in agriculture was banned in 1989 with a mandate to use a maximum of 10,000 tons of DDT per annum for the control of malaria and Kala-azar and this policy is strictly adhered to till date.

The global incidence of malaria is about 500 million cases and according to UN estimate malaria kills one child every 30 sec and more than a million people per annum mainly in Sub Saharan Africa.

One of the eight Millennium Development Goals is to “Halt and begin to reverse the incidence of malaria and other major diseases”. National Health Policy 2002 admits, “Out of the communicable diseases which have persisted over time, the incidence of Malaria staged a resurgence in the1980s before stabilising at a fairly high prevalence level during the 1990s. Over the years, an increasing level of insecticide-resistance has developed in the malarial vectors in many parts of the country, while the incidence of the more deadly P-Falciparum Malaria has risen to about 50 percent in the country as a whole.”

The National Rural Health Mission (NHRM) focuses on providing key attention to 18 Indian states, improving the availability and quality of health care in rural areas, synergy between health and determinants of good health, capacity building and involving the community in the planning process. For 2005-2012, the NRHM identified a list of disease reduction outcomes, including Malaria mortality among other things.

Phanishwarnath Renu in his novel Maila Anchal published in the very year the national malaria control programme captured its impact on the village of Maryganj. The government and global institutions argued that malaria control would increase agricultural productivity.

Malaria almost disappeared by the late 1950s. At the end of 1958, a total of 8,704 malaria squads were in operation who sprayed a total of 438 million houses. The number of recorded cases of malaria fell from 75 million in 1951 to just 50,000 in 1961. The malaria eradication programme employed 1,50,000 people by 1961. Malaria cases accounted for less than 1 per cent of all hospital admissions, an astonishing diminution in the burden of malaria.

There was a resurgence of malaria in the 1960s because of resistance to DDT and to anti-malarial drugs. Reliance on DDT was a consequence of the weakness of India’s health infrastructure. The success of DDT was dependent on medical surveillance that was absent. An active programme of “case-finding” constituted a crucial final stage in malaria eradication that could not be completed.

The development of malaria control policy in the 1950s encapsulates, in many ways, the political culture of public health that evolved after independence. This is, not least, because at its height, between 1959 and 1963, the national malaria eradication programme took up nearly 70 per cent of India’s budget for communicable disease control, itself accounting for nearly 30 per cent of the overall health budget under the second plan.

India became the world’s largest market for DDT. The malaria eradication programme was heavily dependent on outside funding: between 1952 and 1958, the US contributed more than 50 per cent of the cost of the programme, and nearly 40 per cent of the cost of the eradication programme between 1959 and 1961. The national malaria control programme turned into malaria eradication. The memoirs of D K Viswanathan, India’s foremost malariologist at the time refers to the effort as “worship at the altar of science”.

In 1963, the USAID stopped providing DDT to India due to debates in the US about the safety of DDT, following Rachel Carson’s seminal publication, Silent Spring. India was compelled to purchase DDT from US under a long-term loan agreement.

India has spent up to 25% of its health budget on malaria control from 1977-1997, and starting in 1997, India planned to spend $40 million on malaria control, a 60% increase from the previous year. This expenditure is part of a five-year program aimed to target 100 districts where 80% of all P. falciparum cases occur. 70-80% of the malaria control money in India is spent on insecticides.

in 1976, 6.45 million cases were recorded by the National Malaria Eradication Programme (NMEP), highest since resurgence. The implementation of urban malaria scheme (UMS) in 1971-72 and the modified plan of operation (MPO) in 1977 improved the malaria situation for 5-6 years. Malaria cases were reduced to about 2 million. The impact was mainly on vivax malaria. Easy availability of drugs under the MPO prevented deaths due to malaria and reduced morbidity, a peculiar feature of malaria during the resurgence. The Plasmodium falciparum containment programme (PfCP) launched in 1977 to contain the spread of falciparum malaria reduced falciparum malaria in the areas where the containment programme was operated but its general spread could not be contained. P. falciparum showed a steady upward trend during the 1970s and thereafter. Rising trend of malaria was facilitated by developments in various sectors to improve the national economy under successive 5 year plans.

Malaria at one time a rural disease, diversified under the pressure of developments into various ecotypes. These ecotypes have been identified as forest malaria, urban malaria, rural malaria, industrial malaria, border malaria and migration malaria; the latter cutting across boundaries of various epidemiological types.

Further, malaria in the 1990s has returned with new features not witnessed during the pre-eradication days. These are the vector resistance to insecticide(s); pronounced exophilic vector behaviour; extensive vector breeding grounds created principally by the water resource development projects, urbanization and industrialization; change in parasite formula in favour of P. falciparum; resistance in P. falciparum to chloroquine and other anti-malarial drugs; and human resistance to chemical control of vectors.

The US Environmental Protection Agency (EPA) in had special hearings during 1971-1972 regarding the continued use of DDT following which it declared the ban on DDT in 1972 owing to ecological and reproductive health problems. As a result of campaigns by Royal Malaria Foundation International and other agencies to prevent a ban on DDT its use in public health emergencies like outbreaks of malaria was exempted from the ban. During 1970 to 1986, a total of 34 countries mostly from developed nations implemented the ban.

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 that have notified to the secretariat for its continued use. 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 in Africa and other areas where the vectors are still susceptible to DDT is believed to be the result of corporate influence.

The currently used pesticides globally cause about 20,000 deaths annually by accidental and deliberate/intentional poisoning. 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.

Saturday, September 08, 2007

Union Cabinet clears unorganised sector Bill

The Union Cabinet today approved the revised Unorganised Sector Workers Social Security Bill, 2007.

The Bill, which will be introduced in the current session of Parliament, will facilitate formulation of social security schemes for the unorganised sector workers.

The Cabinet also approved a health insurance scheme for below-poverty-line workers and their families in the unorganised sector. The scheme will be launched in a phased manner starting from October 2, 2007. States have to formulate projects under this scheme.

“The beneficiaries will be issued smart cards for the purpose of identification,” Information and Broadcasting minister Priyaranjan Dasmunshi said.

The Cabinet also cleared establishment of the National Institute of Science Education and Research (NISER) in Bhubaneswar at an estimated cost of Rs 823 crore. The NISER will function as an autonomous body under the Department of Atomic Energy and will be the first of its kind under the DAE umbrella for undergraduate education in basic sciences.

The Cabinet also approved outsourcing of front-end activities of passport issuance, through an open bidding process, to one or more service providers. It will also set up 68 passport facilitation centres and use the current passport offices as passport back-offices.

The Cabinet Committee on Economic Affairs (CCEA), which also met today, gave its approval for continuation of the Rural Employment Generation Programme (REGP) till the end of the current financial year. It granted Rs 445 crore towards the REGP for the current financial year.

The CCEA also approved continuation of centrally sponsored scheme of Post-Matric Scholarship to students belonging to Scheduled Castes, with an estimated expenditure of Rs 5000 crore during the 11th Plan. Now the scheme has been extended to the free seats of private institutions also. September 07, 2007

Business Standard

Sunday, September 02, 2007

Public Health Beyond Medicine

In an editorial 'Public health in India and the developing world: beyond medicine and primary healthcare' in the Journal of Epidemiology and Community Health, July 2007 reminds, "Public health in India relies primarily on medicine to achieve its goals. Successive governments in India have come up with many schemes for the provision of safe water, sanitation, nutrition, vaccination coverage, education and employment. Despite the many attempts, millions of people do not have access to these basic needs, malnutrition is rampant in children and vaccination coverage is inadequate among the poor."

The National Health Policy 1983 proposed "to provide ‘Health for All by the year 2000 AD’, through the universal provision of comprehensive primary health care services." The National Health Policy-2002 noted, "In retrospect, it is observed that the financial resources and public health administrative capacity which it was possible to marshal, was far short of that necessary to achieve such an ambitious and holistic goal."

The policy of 2000 dealing with the Extending Public Health Services admitted, "While there is a general shortage of medical personnel in the country, this shortfall is disproportionately impacted on the less-developed and rural areas. No incentive system attempted so far, has induced private medical personnel to go to such areas; and, even in the public health sector, the effort to deploy medical personnel in such under-served areas, has usually been a losing battle. In such a situation, the possibility needs to be examined of entrusting some limited public health functions to nurses, paramedics and other personnel from the extended health sector after imparting adequate training to them."

The 2002 policy elaborated on the State of Public Health Infrastructure saying,
"As a result of such inadequate public health facilities, it has been estimated that less than 20 percent of the population, which seek OPD services, and less than 45 percent of that which seek indoor treatment, avail of such services in public hospitals. This is despite the fact that most of these patients do not have the means to make out-of-pocket payments for private health services except at the cost of other essential expenditure for items such as basic nutrition."

The editorial aptly locates Health solutions beyond medicines to which the policymakers, "The survival of the human body is best explained by the materialist explanation that locates the variation in health and longevity to tangible resources. The reciprocal relationship between poverty and disease had long been acknowledged by public health reformers who advocated social reform on political, economic, humanitarian and scientific grounds."

Thursday, May 31, 2007

Toxic Ship Export to UK Stopped

Toxic Ghost Fleet Ship Export to UK Stopped
Legal challenge keeps recycling jobs in the U.S.

Indeed the real real victory is that hurndreds of end of life ships are not going to India or China because the UK was trying to open the pandora's box. This has now been closed for ever by Producer Responsibility for ships a reality.

The Bush Administration's plans to export nine ex-naval “Ghost Fleet” vessels from the James River in Virginia to Teesside, England for scrapping has itself been finally scrapped, according to the Able UK company. American environmental groups responsible for first blocking the deal in 2003 hail its final demise as a victory for American recyclers, and for national environmental responsibility and self-sufficiency in toxic waste management.

In October 2003, the Basel Action Network (BAN) and the Sierra Club, represented by Earthjustice, sued the Environmental Protection Agency and the Maritime Administration (MARAD) to prevent the resumption of US exports of highly contaminated decommissioned naval vessels for scrapping abroad. The suit alleged violations of the Toxics Substances Control Act, the Resource Conservation and Recovery Act, and the National Environmental Policy Act.

The US federal district court in DC ruled that four vessels could cross the Atlantic as their export was mandated by Congress, but prohibited the departure of the remaining nine until MARAD completed an Environmental Impact Assessment, obtained proper authorization to export toxic PCBs, and ensured the existence of an adequate dismantling facility in the UK. Now, after three and one-half years, MARAD has finally decided to annul the contract as the intended ship-breaker, Able UK, has been unable to obtain the permits required to conduct its business in Teesside.

“The death of this contract is good news for the environment and for American workers,” said Martin Wagner of Earthjustice. “The management of US toxic waste is a US responsibility. Why dump our trash in other countries when we can take care of it here and create new jobs at the same time?”

It is expected that the nine ships in the James River will now be put up to bid for domestic ship recyclers. Questions remain as to what will become of the four US ships that sit rusting in Teesside, England. The vessels contain many tons of materials contaminated with carcinogenic and highly toxic substances such as PCBs, asbestos, mercury, used fuel, and other toxic substances.

“The Bush Administration’s original plan to undermine international law has failed,” said Jim Puckett of BAN, “They wanted to shunt a few ships off to the UK to set a legal precedent, and then open the floodgates to China, India, or Bangladesh where workers are dying of cancer and where scrapping is done without strong health and safety rules. Instead of dumping them on the rest of the world, we should be turning these old swords into ploughshares of recycled steel here at home.”

The environmental groups will remain vigilant to halt any future plans to export these ships or any other U.S. ships laden with toxic waste and demand they all be scrapped properly in the United States.

Currently there are 238 old ships in the National Defense Reserve Fleet, most located in Texas, Virginia and California, that will need to be dismantled. Some of the ships are in dangerous condition and pose an environmental threat as they have never been emptied of fuels, oils and other hazardous substances.

“Our precious Chesapeake and San Francisco Bays are no place for floating toxic time bombs,” said Michael Town of the Sierra Club in Virginia. “The budget to remove these vessels and have them properly recycled here in America should have been appropriated long ago. Let’s have these ships scrapped as quickly and as safely as possible here at home and close this sad chapter of exporting our problems overseas.”

Sunday, February 11, 2007

Groups Say No to Japanese "Toxic" Free Trade Agreements

Environmental and public health groups from various countries, including India lodged a collective protest against Japanese free trade agreements (FTAs), which they assert is part of Japan's sinister plan to establish waste colonies in Asia.

In a "fax/e-mail action" held in conjunction with the "Kenkoku Kenen-no-hi" or Japan's National Foundation Day, the civil society groups sent letters to Japanese ambassadors, the Secretariats of the Basel Convention, Stockholm Convention on Persistent Organic Pollutants (POPs), Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), other Multilateral Environmental Agreements, as well as the Human Rights Commission Special Rapporteur on Toxic Wastes, to voice their anxiety and objection to bilateral FTAs that blatantly encourages trade in hazardous wastes.

"We join our Asian neighbors, including our friends in Japan, in standing firm against the illegal and immoral scheme to make our countries dumping grounds for Japanese toxic wastes, technologies and obsolete end-of-life products," said Waste Not Asia coalition in release.

The Manila-based Global Alliance for Incinerator Alternatives (GAIA) described the "fax action" as part of a vigilant campaign to prevent efforts by more powerful countries to exploit nations that are poorer and with weaker regulations and social infrastructures into becoming disposal sites for toxics. \n\n \nTo emphasize its point, the groups cited the case of the controversial Japan-Philippines Economic Partnership Agreement (JPEPA), which contains disturbing provisions that will allow unhindered entry of globally controlled or prohibited wastes and substances from Japan, including extremely toxic materials with heavy metals and persistent organic pollutants such as polychlorinated biphenyls and dioxins. As Japan marks its National Foundation Day, the groups asked the ambassadors and international bodies to relay their demands to Prime Minister Shinzo Abe and the concerned ministries for the removal of waste trade liberalization and other exploitative provisions in the JPEPA and other FTAs that Japan plans to forge with other countries.

The groups further seek Japan's immediate ratification of the Basel Convention's Ban Amendment, which prohibits the export of toxic wastes from developed to developing countries for any reason. Japan signed bilateral FTAs with ASEAN member states such as Singapore in 2002, Malaysia in 2004 and the Philippines in 2006 and is currently working on similar agreements, in various stages, with India, Indonesia, Thailand, South Korea, Vietnam and other countries.

The Manila-based Global Alliance for Incinerator Alternatives (GAIA) described the "fax action" as part of a vigilant campaign to prevent efforts by more powerful countries to exploit nations that are poorer and with weaker regulations and social infrastructures into becoming disposal sites for toxics.

To emphasize its point, the groups cited the case of the controversial Japan-Philippines Economic Partnership Agreement (JPEPA), which contains disturbing provisions that will allow unhindered entry of globally controlled or prohibited wastes and substances from Japan, including extremely toxic materials with heavy metals and persistent organic pollutants such as polychlorinated biphenyls and dioxins.

As Japan marks its National Foundation Day, the groups asked the ambassadors and international bodies to relay their demands to Prime Minister Shinzo Abe and the concerned ministries for the removal of waste trade liberalization and other exploitative provisions in the JPEPA and other FTAs that Japan plans to forge with other countries. The groups further seek Japan's immediate ratification of the Basel Convention's Ban Amendment, which prohibits the export of toxic wastes from developed to developing countries for any reason. Japan signed bilateral FTAs with ASEAN member states such as Singapore in 2002, Malaysia in 2004 and the Philippines in 2006 and is currently working on similar agreements, in various stages, with India, Indonesia, Thailand, South Korea, Vietnam and other countries.

Japanese Ambassador in India was also sent a letter on 10th February, 2006.