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Delhi to examine 'weak regulation' of clinical trials

Trial and Error - Part 3: Indian authorities admit to the failings exposed by The Independent's investigation into drug tests

Andrew Buncombe
Wednesday 16 November 2011 01:00 GMT

Indian authorities have claimed they plan to tighten regulations over the way medical trials are conducted in the country and address some of the concerns highlighted in The Independent's investigation.

As campaigners in India and around the world repeated their call for better oversight, official sources admitted that weak regulation was a problem that needed to be tackled by the Drug Controller General of India (DGCI), the body charged with overseeing and regulating trials.

Last week, Dr V G Somani was appointed to head the body, which is part of the Ministry of Health and Family Welfare. The Health Minister Ghulam Nabi Azad failed to respond to inquiries.

A source within the drugs control department said its priorities would be the establishment of clearer guidelines – especially for dealing with adverse reactions to drugs taken during a trial – a focus on affordable medicine for India, and the development of research and development. "I don't think you can say the oversight was a failure. But it was weak oversight," said the source, who asked not be identified given the sensitivity of the issue.

In regard to ethical committees, the supposedly independent bodies that oversee and monitor trials, the source added: "The committees have to be made more accountable, by law." But the source said the committees' ability to oversee was limited. "They cannot inspect every day," the source added.

Sandhya Srinivasan, executive editor of the Indian Journal of Medical Ethics, said there was a pressing need for more effective oversight, given the abuses that have come to her attention. "In theory much of it can be addressed by regulation," she said. "Another larger concern is that effective, life-saving drugs tested in India are not available in India at anywhere near an affordable price."

Dr Anand Rai, a physician turned whistle-blower from Indore, where he exposed trials that a police inquiry said breached ethical guidelines, also said it was important the authorities focused on the trials of drugs designed to tackle diseases that are common in India, such as malaria and dengue. He also called for better regulation of ethical committees.

Brinda Karat, an opposition MP who has led calls for better oversight, said changes made to legislation that loosened regulations "must be reviewed in the light of the experience of the last six years. Also, the pending bill on regulation must be placed before the parliament". She added: "Strong action [must be taken] on the cases you have written about."

Some say there must be a complete overhaul. Dr Chandra Gulhati, editor of the Monthly Index of Medical Specialties and the man who has collated much of the data regarding drug trials in India, said many believed the changes made in 2005 had helped foreign drug companies by reducing costs and providing easy access to trial subjects, but had provided little benefit to India.

"What does India get as a nation?" he said. "I believe the issue is not of tightening the rules but revisiting the entire process of unconditional liberalisation. When India permits British Airways to start a service to India, Indian carriers in return get the same facility. This is reciprocal. In the drug field there is just one-way traffic."

Europe: MEPs target companies using 'guinea pigs' overseas

An influential group of MEPs have vowed to stamp out unethical clinical trials by forcing European regulators to take more robust action against drug companies guilty of violations.

The MEPs are urging a key European committee to hold emergency discussions amid growing evidence of ethical abuses in developing countries. The European Medicines Authority (EMA) has been accused of failing to enforce existing laws that stipulate only drugs tested ethically, to international standards, should be licensed in Europe.

The EMA, responsible for approving new drugs in Europe, told The Independent that the globalisation of clinical trials posed a "huge challenge" that needed more resources and better cooperation from the pharmaceutical industry.

Dr Peter Liese, German Christian Democratic MEP, said rejecting just one unethically tested drug from the European market would serve as a "powerful message" to the whole industry. "We have a big problem and we need to do better," he said. "But it is not a question of new laws, it is about implementing existing ones."

Margrete Auken, Danish Green Party MEP, said Europe must treat unethical clinical trials with the same gravity as organ trafficking and called for companies to be "named and shamed".

There are almost 120,000 clinical trials currently taking pace in 178 countries. But only 36 of those countries have effective drug regulators, including just one in Africa, one in Latin America and three in Asia. This means Western regulators, including the EMA and the US Food and Drug Administration, know that huge numbers of clinical trials are taking place without adequate supervision. The EMA has never rejected a new drug solely on the basis of ethical violations.

Critics say that the watchdog's current approach is inadequate. "The EMA must start asking drug companies for information about how they safeguarded the safety of participants before they grant authorisation," Annelies den Boer, of the Dutch health NGO Wemos, said. "Europe is the second-largest drug market in the world, so we need to send a strong signal to companies that they cannot get away with it."

Dr Amit Sengupta, from Health Action International, said: "The [Western] regulators are becoming wary about poorly regulated countries not because of the unethical practices, but because they are worried about quality of the data which could harm their own patients."

In the UK, Lord Leslie Turnberg, former NHS doctor and chair of the All Party Parliamentary Group on Medical Research, said he would consider investigating the issues raised by The Independent. British and US lawyers are also considering the evidence to determine whether civil cases can be brought.

Nina Lakhani

Polio vaccine: An ethical dilemma

A new vaccine tested in Indore has emerged as a key tool in India's battle against polio. And in the process it has shown how complex the questions over ethical drug trials are bound to be.

Some of the research on the medication was carried out at the Maharaja Yashwantrao hospital in Indore, the same one that has had new trials suspended amid allegations that a small group of doctors conducted trials in breach of regulations. (The doctors and the hospital deny the charges.) The vaccine is important because it can immunise children against two key strains of the virus in a single dose. The long-running struggle to eliminate polio in India is looking better than it ever has: last month officials said there had been only one reported case this year.

Dr Hemant Jain, a US-trained paediatrician who was involved in testing the vaccine and who denied there had been a breach of guidelines, claimed the controversy had put back drug trials in India by 10 years. "The WHO came to us with a request to test a new vaccine. Credit has been given to this new vaccine and 75 per cent of the work was done in Indore," he said.

Breaking the rules A worldwide epidemic


There are 2,520 trials for China currently on the US registry, but it is almost impossible to ascertain the regulatory situation. Researchers working for the Dutch NGO Wemos tracked down trial participants by hanging around hospitals and university campuses where recruitment posters are common.

Ms Liu, 47, a poor farmer from near Beijing, agreed to take part in a trial for an anti-cancer drug by a Chinese company manufacturing traditional herbal medicines. She had been diagnosed with brain and lung cancer and could not afford treatment. The hospital conducted a lottery because so many poor people were desperate for the free care. "I didn't really understand what a clinical trial means," she said. "But we are poor farmers and the most important thing for us is to save money... I had the treatment a few months ago but I have no idea if the medicine worked. I am still very ill."


Data from 167 pivotal trials was submitted from Poland to the EMA between 2005 and 2009, making it the sixth most popular European destination at that time.

Research by the NGO Wemos published in 2010 found CROs and drug firms actively recruiting vulnerable people, such as the homeless, in return for small payments.

In one case, Ania, 34, a successful businesswoman from Warsaw, volunteered for a fertility drug trial sponsored by a US company. She fell pregnant but miscarried after six weeks, and signed up again three months later. In the meantime her husband, a doctor, obtained the medical reports and found that the foetus had been severely deformed. "The CRO was very reluctant to let us get out of the [second] contract... if we said anything or anything showed up in the media, they would sue us." Ania is in a legal battle to get out of the confidentiality agreement.


With only one language and a large, ethnically diverse population concentrated in major cities, Brazil is the most popular destination for clinical trials in South America. There are 2,520 trials currently listed on the US clinical trials registry, partly explained by the 150 million uninsured Brazilians who are desperate to gain access to medical treatment.

Brazil, like India, has recently relaxed regulatory systems to speed up the approval of clinical trials, allowing CROs to operate without accreditation – registration with the chamber of commerce is enough to start testing drugs on humans. At least 26 CROs operate in Brazil, mostly in Sao Paulo, including eight of the top 10 multinationals.

Independent oversight by regulatory authorities and ethics committees in Brazil "leaves a lot to be desired", the NGO Somo has warned.

* From tragedy to travesty: Drugs tested on survivors of Bhopal
* Without consent: how drugs companies exploit Indian 'guinea pigs'
* Leading article: Drugs firms must not prey on poverty
* Drugs policy advisor under fire over links to pharmaceutical company

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