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The change in Maldives
Take-off problems |
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Forest cover in Punjab No govt role in 100 sq km gain THE biennial India State of Forest Report, 2011, has revealed that the national forest cover has gone down by 367 sq km over two years, even as in Punjab it has increased by 100 sq km. The national forest cover as per data collected towards 2008-end is 21 per cent of the total land, obviously disappointing news for a country that has set itself a target of 33 per cent.
Questions over media’s role
My sweetheart
Trial travails
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The change in Maldives
India has played its card wisely by not taking sides in the tumultuous developments in the Maldives, leading to the sudden resignation by President Mohammed Nasheed, the first democratically elected head of government there. Any attempt by India to ensure the continuance of Mr Nasheed because of his pro-New Delhi policies would have been harmful not only for India but also for the ousted President. He would have been labelled a stooge of India and this country would have been accused of having expansionist designs in South Asia. India’s image is bound to improve owing to its non-interfering role. Now it can keep its head high in the comity of nations as well as in the South Asian Association for Regional Cooperation (SAARC). The restrained approach in the wake of the coup staged by the police and a section of the army in the Maldives on Tuesday may help protect New Delhi’s interests in this member-nation of SAARC. Mr Nasheed suffered the ignominious exit from the Maldivian presidency partly owing to the rising clout of fundamentalists and partly because of his failure to grow from a pro-democracy activist to the ruler of a country. The Maldivians considered him a hero who consistently fought against the dictatorial regime of his predecessor, Maumoon Abdul Gayum. That is why they voted him to power in the first presidential election in 2008. But his party could not get enough seats in parliament to form a government on its own. He had to depend on other parties — including those having religious leanings --- to run the government. He had to learn to respect all shades of opinion, at least the parties that joined his camp after the polls — the “December 23 Coalition”. However, Mr Nasheed has shown maturity in resigning as President without much resistance. He has saved many precious lives which might have been lost had he asked the section of the armed forces loyal to him to challenge the coup leaders. The young tree of democracy that he had planted would have also been weakened. His admirable conduct under the grave circumstances may help him come back to power whenever fresh elections are held.
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Take-off problems THE idea of allowing India’s airlines to import jet fuel directly has not been well thought out. If approved by the Union Cabinet, the proposal made by a ministerial committee headed by Finance Minister Pranab Mukherjee would help the private airlines save on state taxes, which are hefty by global standards. The announcement of the proposal saw the airline stocks fly high. But the airlines’ gain would mean the states’ loss. The states – Maharashtra, Tamil Nadu, Andhra Pradesh and Delhi – as well as the government oil marketing companies naturally oppose the move. To compensate themselves for the revenue loss, the states may raise the entry tax on oil, thus nullifying the gain to airlines. Direct imports of jet fuel are not practical or feasible because of limited infrastructure available. If airlines tie up with some private oil company for the import of aviation turbine fuel (ATF) as is being planned, the savings from state taxes may have to be passed — partly or even entirely — on to the companies for arranging the direct import, storage and distribution of fuel. More importantly, giving the airlines tax incentives to import jet fuel makes no sense when plenty of it is available within the country. Currently, India exports half of its jet fuel production annually. Going by the principle “the polluter must pay”, the airlines must be taxed to meet environmental costs. What the government can do is to create a level-playing field for the airlines — as also for other industries — to make them competitive. Taxes and interest rates may be rationalised accordingly. There is a valid case for allowing foreign airlines to have up to 49 per cent stake in Indian carriers. But in no way inefficiency or mismanagement must be patronised. Private airlines and Air India have made mistakes and they must pay for these. Frequently giving tax-breaks or using the taxpayers’ money to bail out badly managed industries is unacceptable. The inefficient ones must be allowed to collapse. |
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Forest cover in Punjab
THE
biennial India State of Forest Report, 2011, has revealed that the
national forest cover has gone down by 367 sq km over two years, even
as in Punjab it has increased by 100 sq km. The national forest cover
as per data collected towards 2008-end is 21 per cent of the total
land, obviously disappointing news for a country that has set itself a
target of 33 per cent. Close scrutiny of the data for Punjab, despite
the gain, would reveal there is nothing for the state to cheer either.
Out of the 100 sq km gained, 97 sq km is in the “open forest”
category (density 10-40 per cent in a hectare), and only 3 sq km is
“moderately dense”. Punjab has 6.12 per cent of its land that is
“forest area” in revenue records. The forest cover, however, is
only 3.5 per cent, which means just a little over half the potential
forest land is actually forest. A saving grace is that tree patches of
less than 1 hectare, outside forest area, add up to another 3.37 per
cent. That the government has played little role in the forest cover
increase is apparent from the fact that the gain is in open forest,
most of which is poplar and eucalyptus plantations of farmers.
Hoshiarpur and Roopnagar districts, which have around 20 per cent area
under forest, have gained only 3-4 sq km each of forest cover. The
biggest gain of 16 sq km has been in Amritsar, a non-forest area. The
Forest Departments of both Punjab and Haryana (the latter has a mere
14 sq km gain) are known more for internal wrangling than any
afforestation work done. It is suspected most of it arises from clash
of unscrupulous vested interests. Plantation projects aided by
external agencies in both states have come under a cloud for alleged
embezzlements. From auction of the trees cut in Punjab for road
widening, the government has earned huge amounts, but little has been
released for compensatory plantation. Sadly, afforestation is a
business that for various reasons has to remain with the government,
or under its direct supervision. |
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Don't find fault, find a remedy.—Henry Ford
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Questions over media’s role
HOW free is the media or, for that matter, how free is the right to express oneself? This is the question which has arisen in India after the three speeches, one by Vice-President Hamid Ansari, another by Prime Minister Manmohan Singh and yet another by Justice Markandey Katju, chief of the Press Council. The right to say has assumed all the more importance after Salman Rushdie’s non-participation at the Jaipur Literature Festival because of threats. In Pune, screening of a documentary on Kashmir was stopped following protests by the students’ wing of the BJP. Talking of the first two speeches, both the Vice-President and the Prime Minister have asked the media to introspect their role because of sensationalism that has crept into their dissemination of news and views. There was not even a hint of direct or indirect control of the media in their speeches. However, Justice Katju has warned the media that some regulation may have to be imposed as self-regulation is no regulation. Since Independence, New Delhi’s record has been clean except when censorship was imposed during the Emergency (1975-77). Governments have followed Prime Minister Jawaharlal Nehru, who assured the All-India Newspaper Editors’ Conference as back as on December 3, 1950: “I would have a completely free Press with all the dangers involved in the wrong use of that freedom than a suppressed or regulated press.” Justice Katju appears to be on a different pitch. He should know that the Press Council was constituted to safeguard the Press freedom. Unfortunately, his speeches reflect little understanding of the media’s nitty-gritty or its culture. To dub journalists illiterate within a day of becoming the Press Council chief has only alienated him from them. Journalists do not qualify for the job they do with all the degrees they can acquire if they do not write well, have no nose for news or lack analytical ability. S. Mulgaonkar, one of the leading editors that India has produced, was not even a graduate. My worry is that the media is becoming a part of the establishment. In a free society, the Press has a duty to inform the public without fear or favour. At times it is an unpleasant job, but it has to be performed because a free society is founded on free flow of information. If the Press were to publish only government handouts or official statements, there would be nothing to pinpoint lapses, deficiencies or mistakes. In fact, the truth is that the Press is already too niminy-piminy, too nice, altogether too refined and too ready to leave out. Still the greater danger is that the profession is becoming an industry and tending to project views of the corporate sector. Somehow those who occupy high positions labour under the belief that they-and they alone-know what the nation should be told and when. And they get annoyed if any news which they do not like appears in print. Their first attempt is to contradict it and dub it mischievous. Later, when it is realised that a mere denial will not convince even the most gullible, a lame explanation is offered that things have not been put “in proper perspective.” I served the first Press Council. Every member felt that the Council should be without teeth. It was founded as a body of peers who should judge peers. Justice Katju’s argument that the Council should have powers to penalise defeats the very purpose of its founding. It is not a court. There are already enough of them and one can be created for the media alone. But the purpose of constituting the Council is to leave it to the Council members — journalists and proprietors-to decide how to improve the erring publication. The slide began when the paper which the Council censured would not even publish the judgment against it. Even when the publication concerned was told where it violated the ethics, it did not bother. I think it should be made obligatory for the papers to print the Council’s decision, however unfavourable. Justice Katju should see the record of the Council which has been invariably an extension of the Information and Broadcasting Ministry. The Council was at its worst during the Emergency when its chairman was at the end of a telephone call by Information Minister V.C. Shukla, who played havoc with the Press. George Verghese was wrongly dismissed by The Hindustan Times, but before the Council could give its verdict in his favaour, it was abolished. Even lately, the Council did not live up to its independent status. There were many complaints against the Press on what came to be recognised as “paid news”. News columns, considered sacrosanct, were used to campaign for a candidate who paid money. The Council’s original report had to be watered down because of the pressure exerted by proprietors of newspapers and television channels. Justice Katju’s warning against paid news is all right, but he may find the Council itself divided on the subject. As regards Salman Rushdie, he had to cancel his visit because of threat to his life. Probably, the government was equivocal in providing him security. But this is not the point. The democratic polity that India is guarantees the freedom of speech. Some fundamentalists, who had taken umbrage at his book, “The Satanic Verses”, made the entire Muslim community a hostage. Liberal Muslims never speak out although they are vociferous in condemning Hindus on any act of omission or commission. The Supreme Court has said: “The personal liberty of an individual is the most precious and prized right guaranteed under the Constitution.” The Deoband seminary should realise, if it has not done so far, that in a secular society the constitution is above fatwa. M.F. Husain met more or less the same fate at the hands of Hindu fanatics. All such voices are marginal and do not represent the majority. The write to free expression was violated at the Symbiosis College of Arts and Commerce which cancelled the screening of a documentary on Kashmir. The institute had received a notice from the Akhil Bharatiya Vidyarthi Parishad (ABVP) which objected to the screening of the documentary, calling it “separatist.” The documentary-”Jashn-e-Azadi” by Sanjay Kak-spoke against the Army and in a way justified terrorists’ functioning in the Valley. (In protest, I am resigning from the position of Professor-Emeritus in Journalism at Symbiosis). No doubt, the space for free expression is shrinking all over the world. Yet I always thought that India would be an oasis in the desert of suppression and restriction on free expression. The fanatics and a weak government have proved me wrong. In Rushdie’s case, the UP election aggravated the problem because the state has nearly 15 per cent Muslim electorate while the screening of the Kashmir documentary had to be cancelled to placate the Hindutva
crowd.
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My sweetheart
There is one and only one living being on the planet whom I worship, rather adore like anything. Readily I am prepared to cater to the whims of the coveted one. “The great arrival” ushers in a whiff of fresh air — it enlivens the whole atmosphere. It carries an electrifying charm as if after a prolonged power cut electricity is restored suddenly. Lends a new glow to everything around. Not only myself but others too brighten up and get cheery all of a sudden. A total transformation and metaphorsis does take place. Everything gets into order and it does virtually look like a real home. A “jadu ki chari”, indeed. I thank the Almighty hundred and one times for starting the day on a cheerful note when there is a knock on the door. In fact, the Lord has been merciful to me in granting me this privilege which very few enjoy these days. Heaving a sigh of relief, I settle with my morning cuppa before TV humming my favourite lines. I get edgy if the hands of the clock move “faster”. My BP shoots up and pulse runs a marathon race. I feel as if the heavens have fallen upon me and am about to collapse any moment. You can’t imagine how jittery and fidgety I get. All goes topsy turvy. It seems as if a holocaust has brought about an upheaval in the house. Suddenly, it gets noisy and things start falling here and there with a bang. Confusion reigns all around. I bemoan the day! What if I have to part with expensive gifts on festivals considering that it is a bait to someone to get hooked to me? Don’t we offer costly gifts to our friends and relatives? And, of course, to those whose favour we do seek. If the so-called VIP does turn up daily, it is the biggest favour I seek in my life. Bribery is the hallmark of our social set-up. How can an average mortal like me remain unaffected by it? Hence gladly I offer a steam press, a pressure cooker, a silk sari, etc, on Diwali and other festivals. Herein lies the top secret of my happy family. You judge it yourself. Can I celebrate any festival, hold kitti parties or be a socialite on my own? The blessed one gives me the gift of staying in a cosy bed even in this season of fog and snow. Above all, with the help of this gracious presence, I am able to watch my favourite serials on the small screen. Chatting with friends about female characters, their alluring jewellery and exotically embroidered saris over long mobile calls has become my hobby. People all over the world greet each other on the eve of New Year. But for me everyday is a New Year Day and I greet myself when I open the door to someone with a dark face decked up with bright red bindi, shiny lipstick on broad lips displaying Binaca smile. O’ she is my indispensable sweetheart
Kalavati.
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Trial travails Meanwhile, Health Minister Ghulam Nabi Azad expressed concern on the matter and said that certain rules and regulations need to be followed while the clinical test is undertaken. The National Human Rights Commission, too, has taken cognizance of a December 2011 newspaper report that mentally ill patients in Indore were subjected to clinical trials to check the efficacy of various drugs. As many as 233 mentally ill patients were subjected to clinical trials to check the efficacy of various drugs, including 42 patients for Dapoxetine, a drug used to cure premature ejaculation. The trials were conducted at private clinics by doctors of the mental hospital attached to the Mahatma Gandhi Medical College, Indore, between January 2008 and October 2010. The incident came to light following Madhya Pradesh Chief Minister Shivraj Singh Chouhan’s answer to a question raised in the Assembly. In March 2004, the Supreme Court hauled up two top biotech companies in India for conducting illegal clinical trials of Streptokinase, without requisite permissions of the Genetic Engineering Approval Committee. Eight senior citizens lost their lives in to these trials. A PIL was filed by Aadar, a New Delhi-based social organisation in this regard. The apex court had confirmed that these trials were illegal. A poor widow in Gujarat was asked by a Contract Research Organisation (CRO) in April 2011 if she was willing to act as volunteer for a cancer drug trial. She was told it may only cause nausea or headaches. Desperate for money, she agreed. Within two years, she was on medicines for joint pains, heart ailments and chest pain. When she approached the CRO, she was asked to prove that her ailments were the side-effects of the trial drug. An agent, who recruits subjects for CROs, on the promise of anonymity confessed that he is usually asked to focus on the poor, as they need money. A daily wager in Vadodara was administered a psychiatric drug for a bio-equivalence study sponsored by Mumbai-based Sun Pharmaceuticals. He developed pneumonia and died.
Non-accountability n
Poor are easy targets. n
Illiterate persons can often be misled. n
Weak legal system. n
Ignorance of Fundamental Rights by the volunteers (Article-21 of the Indian Constitution gives Right to Life and Live with Dignity). n
At present, the guidelines governing the clinical trials are weak and ineffective. According to Dr V. M. Katoch, Director General, Indian Council of Medical Research (ICMR), low costs, weak laws and inadequate enforcement and penalties can be blamed for the present state of affairs.
India favoured hub for clinical trials n
India has strengthened regulations around pre-existing intellectual property rights. It also started recognising international patents for the first time in 2005, which assured pharmaceutical industries that their experimental compounds will not be leaked into the generic drug market. n
In the same year, there was an amendment to Drugs And Cosmetics (II Amendment) Rules, 2005, which now permits concurrent trials. According to this amendment, phases II and III of drug trials discovered abroad can be conducted in India, in the same phase and at the same time as in other parts of the world. Earlier, pharmaceutical companies had to repeat the first phase in India. n
In 2001, the FDA began allowing data collected in developing countries to be submitted for their drug approval process. Before that only 25 per cent data from developing nations was accepted. This is highly profitable for the US drug market, which is knocking on the doors of developing nations. n
Costs of such trials are 60 per cent less in developing countries as reported by a study conducted in India in 2004 by Rabo India Finance. n
Today, India has a large hub of patients having both acute and chronic and lifestyle diseases. The country has genetic diversity, which helps in achieving accurate results. India also has a large treatment-naïve population (people who have the disease, but have not been diagnosed/treated for it), therefore, people, who have not been diagnosed or treated in past, when enrolled in such clinical drug trials, will not have pharmacodynamics (which may be defined as what the drug does to the body) or pharmacokinetics (which is what the body does to the drug) drug interactions. n
In developed nations, enrolling volunteers is difficult. If, at all, they enrol, they are paid heavy compensation when any side-effect or death is reported, because of the trial drug. But in India there are no such checks and balances. n
In India, there are many trained clinicians and private doctors who are ready to register their patients for clinical trials. According to industry sources, India has 500 investigators, more than 5,72,000 doctors and 43,322 hospitals and dispensaries and about 8.7 lakh beds, including both private and public. Besides this, India has three to four million scientists and is an English-speaking country.
Mandatory guidelines for enrolment n
They should be enrolled without threat or any promises, and should give their free consent. n
They should be informed about the motive of such trial in a language they understand. n
Informed consent must be taken from them after explaining every step and their signatures taken in the presence of two independent witnesses. In case of a child or a volunteer, who is unable to give consent, their legal guardian should give the consent on their behalf. n
They have a right to quit the trial even when the trial is in progress.
Safeguarding interests According to the ICMR guidelines, it is a pre-requisite that any proposal shall be routed through and have the consent of Institutional Review Board or Institutional Ethical Committees. As per the riders, no new drug or medical device can be used in human treatment unless it has passed through various phases of clinical trials.
International ethics code After World War II, there was the formulation of Nuremberg Code of 1947, an international ethics code for experiments on humans. In World War II, many prisoners of war were subjected to new drugs without having their informed consent. Subsequently, the human rights of the participants were recognised and now any living human being is considered as a legal person whose rights are recognised and are to be protected by the law. In 2006, the ICMR, too, amended and published the new ethical guidelines for biomedical research on human participants, which requires formulation of an Institutional Review Board (IRB) or Institutional Ethical Committee (IEC) for permitting clinical research on human subject. When a new drug is discovered, the office of the Drugs Controller-General of India (DCGI), the regulatory authority, grants permission to conduct clinical trials in India. An ethics committee, formed by the institution conducting the trial, gives its approval. The Clinical Trial Registry of India (CTRI) registers it as a drug being tested in India. The trial is conducted by investigation agencies, which could be CROs or non-profits. Data from trial sites is submitted to th DCGI after which a marketing licence is issued.
ICMR guidelines on ethics n
Ethics committee should do a complete review of research proposals. n
Research should be done on vulnerable sections only when there is a direct benefit from it. The economically and socially disadvantage should not be used to benefit those better than them. n
Informed consent should be taken from the participant. In case the individual is incapable, consent from a legal guardian should be taken. n
Participant may be reimbursed for the inconvenience and time spent during the research. But payment should not be so large as to overwhelm the participants’ better judgment. n
If the drug is found effective on a patient, the sponsor should provide it to him after the clinical trial is over till it is marketed in the country, thereafter, at the reduced rates. n
Participant who suffers physical injury should get financial or other assistance. In case of death, dependents are entitled to compensation. However, these ICMR guidelines have weak legal sanctions. The ethical committees are privately managed and decentralised. Many members are legally ignorant or poorly informed about ethical principles and human rights, while the legal and social science members are alien to the medical jargon. Most volunteers in such trials are poor and illiterate. They having no access to any treatment, fall prey to promises of such multinational drug trials. The government must enact certain guidelines so that such individuals shall not be exploited and who ever violates these guidelines shall be penalised heavily. These amendments are urgently needed so that the safety and rights of Indian subjects are not compromised with.
What should be done Laws must be made more stringent with heavy penalties, if anybody is found violating the guidelines. The government must pass the legislation so that the safety and rights of the subject are not compromised with. Implementation should be very strict. Since June 2009 registration of clinical trials has become mandatory. Functioning of the members of the IECs/IRBs should be more transparent and the minutes of such meetings must made public. Mushrooming of illegal CROs should be stopped and regulated carefully. Declaration shall be asked from the investigator that the volunteers enrolled in the current trial have never participated within last three months in any trial. At present, CROs do not track the number of trials performed on one person. The legal options available to victims of unethical clinical trials conducted outside the European Union are limited. They can sue pharmaceutical and clinical research companies who are domiciled in the European Union but not foreign companies unless there is no other appropriate forum available. The firms can be held liable only if they have been directly involved in managing or controlling the clinical trials in issues that violate ethical standards. This might not necessarily be the regular arrangement. Pharmaceutical companies, which take the form of trans-national corporations consisting of many separate legal entities by principle, do not share the legal obligations of the other members of the economic group. These obstacles can be removed if the legislation allocated civil liability for violations of ethical standards to the company seeking market authorisation of the product, or to the parent company of the trans-national corporation, which sponsored the clinical trial, and extends jurisdiction of the courts of the member state to such parent companies, which are domiciled outside the European Union. Material obstacles faced by victims of clinical trials prevent them from access to justice. These include lack of publicly available evidence, financial costs of litigation and a large array of logistical issues. They can be addressed by specific reforms, shifting the burden of proof, relieving the risk of cost recovery by the other party of litigation, and collective means of redress.
Dr C. S.Gautam is Head of the Department of Pharmacology, Government Medical College and Hospital, Chandigarh. Prof Shashi Sharma is former Chairman of Law Department, Panjab University Chandigarh
International ethical guidelines involving human subjects
Based upon issues faced during the drug trials after World War II, many declarations were made subsequently. The International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS and WHO, 1993).
n
Individual informed consent. n
Essential information for prospective research subjects. n
Obligations of investigators regarding informed consent. n
Inducement to participate. n
Research involving children. n
Research involving persons with mental or behavioural disorders. n
Research involving prisoners. n
Research involving subjects in underdeveloped communities. n
Informed consent in epidemiological studies. n
Equitable distribution of burdens and benefits. n
Selection of pregnant or nursing women as research subjects. n
Safeguarding confidentiality. n
Right of subject to compensation. n
Constitution and responsibilities of ethical review committees. n
Obligations of sponsoring and host countries.
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