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Low-level nuclear deception

India’s former President APJ Abdul Kalam brought himself no credit by visiting the Koodankulam nuclear power project in Tamil Nadu, and declaring it “100 percent safe”. The idea that any technology, especially a complex hazard-prone one like a nuclear power, is “100 percent safe” is patently unscientific. All technologies carry finite risks. The more complicated, energy-dense, and dependent on high-pressure high-temperature systems they are, the higher the risk.

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Superbug vs humbug

Disclosures about the ‘superbug' should jolt the government into paying attention to fast-spreading antibiotic resistance that could leave millions defenceless.

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Regulating the regulator

One of the greatest failures of governance in India lies in appalling poor regulation of entrepreneur activities in the public interest. This is as true of vehicular pollution—less than 200 inspectors for Delhi’s 5 million-plus registered motor vehicles—as it is of such diverse areas as natural gas, education, and the higher judiciary. It is often comfortingly thought that self-regulation is the answer given the near-impossibility of reforming our lethargic and corrupt bureaucracy. Alas, this is largely an illusion.

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Doctors Must Not Oppose Medical Reform: Reviving the healthcare system

Will India’s affluent professionals never stop fighting self-serving battles to defend their privileges even when doing so blatantly violates the public interest? Going by the reaction of the organised medical profession to the government’s proposal to train a special category of rural doctors for a shorter duration than the MBBS course, that seems to be the case. The Indian Medical Association and other guilds representing registered physicians and surgeons have launched strong protests in addition to media advertisements against what they term a “retrograde” proposal, which will “discriminate” against rural India by leaving it at the mercy of “sub-standard” personnel.

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Bhopal - 25 years of shame

The government’s deplorable response to the Bhopal gas disaster and its attempt to shield the polluter constitute a blot on our democracy.

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Technical Committee Approves Bt Brinjal: Paving the way for Frankenfoods?

The future of Indian agriculture and food security doesn’t lie in GM foods. They are unsafe, deliver no real benefits, and are bad for the environment and human health.

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Will To Stop Live Kidney Sales Missing

[Inter Press Service, 8 February 2008 ||en]

by Praful Bidwai

NEW DELHI, Feb 8 (IPS) - The arrest of Indian kidney transplant racketeer Amit Kumar alias Santosh Raut has lifted the lid off a huge well-ramified illicit international organ trading ring with operations running into billions of dollars across several countries.

Kumar, who was tracked down in a resort in neighbouring Nepal on Thursday, has been absconding from the law since Jan. 24, when the police raided his clinic in a Delhi suburb and arrested his associates. He is thought to have been responsible for some 600 illegal kidney transplants.

The global kidney transplant racket is one of the most obnoxious manifestations of North-South inequality and of the repugnant practice of stealing organs from the poorest of the poor in the Third World, usually for patients in rich countries suffering from end-stage organ failure.

India is a major source of organs sold in the illicit international bazaar. Donors are usually induced into selling a kidney - for as little as 1,000 US dollars to a maximum of 2,000 dollars - just to survive.

The bazaar itself is highly evolved, with extensive cross-border transactions and a hierarchy of preferences and prices.

Thus, kidneys from South Asian countries, the Philippines and much of sub-Saharan Africa are sold for as little as 1,000 - 2,000 dollars according to a medical professional who has tracked organ trading, but who insisted on anonymity.

"A Romanian kidney goes for 3,000 dollars," he says. "A kidney from Turkey costs 10,000 dollars plus. Mexico, Brazil and South Africa fall in between. These base prices are marked up by middlemen, and further jacked up by the high fees that unscrupulous doctors charge."

The source adds: "The recipient can end up paying anything between 35,000 and 125,000 dollars for kidney donation, including hospital stay and operation charges."

Trade in human organs poses a series of ethical and practical challenges to the medical profession, healthcare regulators, governments and the larger public.

But it also opens an opportunity for investigative and oversight agencies to develop innovative methods to track down and bring to justice those who profiteer on the backs of the destitute.

Kumar has been conducting his ghoulish business, since 1994, from numerous facilities spread across India's national capital region. Earlier, he was based in the central Indian city of Nagpur and in the western metropolis of Mumbai.

According to the police, multimillionaire Kumar was not a surgeon or physician trained in mainstream modern medicine. He had a degree in the traditional Ayurvedic system of indigenous medicine.

His operation in and around Delhi was run on a massive scale and involved three hospitals, five diagnostic centres and 10 laboratories. Besides he relied on a network of more than 50 accomplices, including doctors and nurses, "spotters" and touts who would lure potential donors with the promise of jobs, and thugs who would force them to part with their kidneys.

The kidney donors were typically extremely poor, unemployed people from backward states like Uttar Pradesh and Bihar, who have become victims of India's neoliberal economic policies and are often in deep debt.

The kidney recipients were nationals from several countries, including Canada, Greece and Turkey.

The racket was unearthed thanks to the initiative of an earnest young woman police officer. "But it is inconceivable that it could have been conducted for years without police collusion," says K.S. Subrahmaniam, a scholar and former senior police officer.

Evidence suggests that Kumar evaded arrest last month because he was tipped off by the police. According to one of his chauffeurs, he was arrested some years ago in Delhi with a surgeon who collaborates with him, but was let off upon paying a bribe of Rs 1.8 million (45,000 dollars).

What demarcated Kumar's operation from the kidney trade which flourishes in many Indian cities, including relatively prosperous Chennai, is the use of muscle power against the donors. Typically, extreme economic distress compels poor people to sell their body parts.

But Kumar's goons would abduct and illegally detain their dirt-poor victims, and drug them or beat them into agreeing to the removal of their kidneys.

"This outrageously criminal angle only highlights the gravity of the failure of the police in enforcing the law of the land," adds Subrahmaniam.

Besides flagrant corruption, the kidney scam underscores the dysfunctional state of India's regulatory systems and laws in respect of healthcare and medical ethics. Thus, Kumar could operate his hospitals and clinics in different cities without registering them.

"Some recently passed laws do mandate the registration of such facilities in some states," says Dr Subhash Gupta, a gastrointestinal and liver transplant specialist at Delhi's Indraprastha Apollo Hospital. "But there are few inspectors, and the concerned agencies don't bother to implement the mandate."

Professional self-regulatory bodies like the Indian Medical Council concern themselves only with the registration qualifications of physicians formally trained in mainstream medicine.

However, an estimated third or more of all self-styled medical professionals or healers in India belong to other streams, including Ayurveda, Unani medicine and homeopathy. They escape the regulatory net altogether.

Voluntar organisations like the People's Health Movement and Medico Friends' Circle have long complained of the absence of authoritative medical practice guidelines.

Again, India's state-level food and drug administrations are notoriously weak, ill-equipped and understaffed. They only inspect a minuscule proportion of pharmaceutical factories or chemists for quality.

Virtually anyone who calls himself a doctor can prescribe a range of medicines and be reasonably confident that the chemist will sell them. This is true even of drugs that can only be sold on the recommendation of a qualified medical practitioner.

In 1994, India enacted the Transplantation of Human Organs Act (THOA), which illegalised the sale of human organs and facilitates organ donations from the brain-dead (cadaverous transplants). But it came years after illegal transplants had become established.

The Act allowed organ donations by close relatives without government clearance. But all other relatives or strangers who wish to donate must be cleared by an expert Authorisation Committee.

In practice, such committees are rarely formed before a potentially illegitimate transplant is carried out. THOA also has a big loophole. It dispenses with prior approval if the donor feels "affection" or "attachment towards the recipient". This is so vague as to permit extensive mercantile abuse.

In India, like in most other Third World countries, the donors' consent is typically secured through coercion or under extremely exploitative and unequal conditions. It cannot be remotely termed free or informed.

The donors are usually quickly discharged without being warned of risks from their surgery. There's no follow-up treatment, nor any attempt to monitor if the remaining kidney malfunctions. Many donors end up ill and even more destitute.

The medical profession's involvement in the organ trade racket betrays the Indian elite's contempt for human life and the principle of inviolability of the human body, which is fundamental to any civilised society.

This view justifies the raiding of flesh-and-blood people to steal their vital but non-regenerating organs. It places an abysmally low value on the bodies of vulnerable people and accepts their ‘cannibalisation’.

The Indian medical profession has long been complicit in all kinds of malpractices, including female foeticide, leading to "27 million missing women" through a falling sex ratio. But only 66 cases have been registered against doctors for sex selection, so far.

"Yet, there is a smart way of detecting and zeroing on clandestine organ transplants," says Dr Gupta. "All transplant recipients are given immuno-suppressant drugs, such as cyclosporin, tacrolimus and mycophenolate. These are only made by a handful of companies like Novartis Roche and Panacea, which know exactly which hospitals/clinics order them."

If the Indian government and its police agencies muster the will, they can easily track, monitor and raid these centres of crime, said one conscientious doctor.


Novartis Patents Case Far From Dead

Inter Press Service, 9 August 2007

by Praful Bidwai

NEW DELHI, Aug 9 (IPS) - Cancer patients in India have reason to be relieved at a high court ruling this week which dismissed a petition by Swiss pharmaceuticals multinational corporation (MNC) Novartis challenging an Indian law which denies patents for minor or trivial improvements to known drugs.

At immediate stake is the cost of a leukaemia drug, imatinib mesylate. Novartis prices its brand of the medicine, Gleevec/Glivec, at Rs 120,000 (3,000 US dollars) per dose. Indian generic drug manufacturers sell it at Rs 8,000 (200 dollars).

India’s average per capita annual income is equivalent to only a fifth of the price of a single dose of Gleevec/Glivec. Had Novartis been granted a patent on its version of the drug, tens of thousands of Indians would have been deprived of life-saving treatment.

The Novartis judgment will have far-reaching implications for generic drugs used in many countries of the world for the treatment of countless diseases and disorders, including vaccines for HIV-AIDS, as well as medicines for cancer, asthma, heart disease and mental illness.

Health activists the world over, including Medicins Sans Frontieres (MSF), the Berne Declaration group, as well as the All-India Drug Action Network (AIDAN) based in this country, have welcomed the verdict in the Novartis case for its "positive impact on public health" and the cause of promoting patients’ access to affordable medicines.

They see the judgment as a vindication of India’s Patents Act, in particular its Section 3(d), which disallows frivolous patents for "the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance". They have also appealed to Novartis not to contest the judgment.

However, the Indian government is itself reportedly planning to amend that very Section to allow the "evergreening" of patents on the original molecule of a new drug through its marginal modification which does not constitute an original invention.

This will in effect achieve more than Novartis can by appealing the Madras (Chennai) High Court verdict in India’s Supreme Court.

"That would make a travesty of the very rationale of one of the few measures in the Patents Act of 1970, amended in 2005, which protects the public from the abuse of a monopoly patent right granted to corporations," says Mira Shiva, a long-standing health activist with AIDAN.

Adds Shiva: "The sour irony is that by changing Section 3(d), the government would be sanctifying the discredited report of an official committee on patent laws, headed by the former director general of the Council of Scientific and Industrial Research (CSIR), R.A. Mashelkar, which had recommended just such an amendment."

The Mashelkar report created a scandal six months ago because it plagiarised text pertaining to "incremental innovations" (or marginal modifications to patented drugs) from a document prepared for a pro-Big Pharma think-tank based in Europe, funded by drug multinationals, including Novartis.

Disgraced and embarrassed, Mashelkar himself withdrew the report, although he unconvincingly denied the plagiarism.

But India’s commerce ministry is now trying to smuggle his recommendation into law though the backdoor. "The Economic Times" reported Thursday, quoting a senior bureaucrat, that the government is planning to allow "incremental innovation" by redefining "efficacy" enhancement.

That would entirely negate the effect of the Madras High Court judgment, dismissing Novartis’ contention that section 3(d) is "vague, arbitrary and violative of Article 14" of the Indian Constitution, which guarantees the right to equality and non-discrimination.

Novartis also claimed that the Section does not comply with the Trade-Related Intellectual Property Rights (TRIPS) agreement of the World Trade Organisation, mandating a strict patent regime, which India has signed.

The Court ruled that it had no jurisdiction to decide whether Indian patent laws comply with TRIPS; and that Section 3(d) does not suffer from "vagueness, ambiguity and arbitrariness" and contains reasonable "in-built protection" for patent applicants.

Novartis can appeal against the judgement in the Supreme Court, or get the Swiss government to move the WTO’s Disputes Settlement Body against it. The company has not announced what it intends to do.

The fate of Section 3(d) of the Indian Patents Act will have a huge impact on the health situation in the countries of the Global South.

India, called "the medicine factory of the Third World", is a leading manufacturer of generic drugs and has successfully developed cheap but high-quality medicines across a wide spectrum. Indian-made generics cost only a fraction of the same chemical entities manufactured in the West, which enjoy monopolistic privilege through strict product patents.

More than half the medicines currently used for AIDS treatment in the developing countries come from India. Indian-made products are also used to treat over 80 percent of the 80,000 AIDS patients in (MSF) projects.

Currently, nearly 10,000 drug patent applications await examination in India. If India grants "evergreening" patents, that would spell the end of affordable medicines in the developing countries.

That is why the Novartis case triggered widespread protest in global civil society. Over 420,000 people worldwide signed a petition asking Novartis to drop the case.

Among them were Archbishop Desmond Tutu, the former Switzerland president and health minister Ruth Dreifuss (currently chair of the World Health Organisation board on intellectual property and TRIPS), and several members of the European Parliament and the U.S. Congress.

"Given this context, it would be utterly treacherous for the Indian government to amend or drop Section 3(d)," says Dinesh Abrol, a specialist in intellectual property issues at the National Institute of Science, Technology and Development Studies in New Delhi. "The arguments commerce ministry bureaucrats advance for doing so are largely specious and wrongly hold that India will lose foreign direct investment in the drugs industry and offshoring opportunities in pharmaceuticals research and development (R&D)."

Many researchers argue that R&D offshoring is largely a function of low costs and the state of the pharmaceutical sciences in India, and not of the degree of patent protection. "There is no evidence that India has lost contracts because of poor intellectual property protection or lack of confidentiality in pharmaceuticals research," says Abrol.

He adds: "What the government needs to do after the Madras judgment is to systematically set out in a Patents Office manual the criteria for judging the enhanced efficacy of a drug, including reduced side-effects, contraindications and hard data on assessing greater bio-availability. That's the best way of defending and preventing the abuse of Section 3(d)."

However, it is far from clear if the Indian government, in particular its commerce ministry, itself deeply compromised with the WTO, can summon up the will to defend the public interest against predatory multinational corporations.