The clinical trials industry in developing nations, particularly India, has exploded over the last few years as drug companies have realised the potential for outsourcing trials to this region for fast subject recruitment and major cost savings.
Globally, more than 80 per cent of clinical trials fail to enrol on time, and this recruitment problem is extremely costly for drug companies, contributing to 85-95 per cent of the lost days in a clinical trial.
The fact that much of India's population is not supported by government health insurance virtually presents clinical trial subjects on a plate, eager to participate, as it may be seen as their only hope of affording access to medication and treatments.
As a result, India is now holding the lion's share of the world's contract research business as activity in the pharma market continues to explode in this region.
In 2005 contract research in India was valued at $100-120m (€78-94m) and growing at a rate of 20-25 per cent each year. India holds nearly double the business of its nearest rival, Italy, with a market value of $60-70m.
Fuelling the business are over 15 prominent contract research organisations (CROs), who are now operating in the country, as well as the presence of over ten large multinational pharma companies.
Any companies conducting a clinical trial must make sure they are following the internationally accepted Nuremberg code, laid down in 1947, citing 10 standards to which physicians must conform when carrying out experiments on human subjects.
The code, states that voluntary consent of the person is absolutely essential. The person should have legal capacity to give consent and be able to exercise free power of choice, without any coercion; and should have sufficient knowledge and comprehension of the elements involved as to enable them to make an enlightened decision.
The 2005 amendment to the schedule Y of the Drugs & Cosmetics Act is moving India towards the acceptance of International Conference on Harmonisation (ICH) guidelines for clinical research and the implementation of the product patent act confirms its willingness to accept global confidentiality and data security norms.However, at present, Indian regulatory authorities are not experienced enough and do not have the infrastructure set up to adequately cope with this clinical trial explosion and monitor the situation tightly. Evidence from whistleblowers is leaking out of the country of many patients falling through the cracks of the Nuremberg code.
"The regulatory process in India still has many holes in it and these will take a while to stamp out," Dr Faiz Kermani of Chiltern International, the largest independent employee-owned CRO in the world, told Outsourcing-Pharma.com.In this potential legal and ethical minefield, "Indian regulatory authorities are still trying to find their feet."
Media reports suggesting that the clinical trials being conducted in India often target poor, illiterate and sometimes mentally incapacitated patients, many who are unaware they are even taking part in clinical trials that could be detrimental to their health.
Certain trials carried out in India on Johnson and Johnson's anti-psychotic drug, Risperdal, were among several suspect trials that were singled out in a recent BBC report.
There are even allegations that patients have been killed or severely injured from some of the trials that have been carried out in India on behalf of international drug firms and that some of the drugs being conducted have not even being tested before in animals.
It has been reported that even when consent forms are signed by participants, many of them were signed without the patients really knowing or understanding what they were doing.
The culture in India is one where most patients blindly trust that anything a doctor gives them or tells them to do will make them better, so if they are asked to sign a consent form, they do so without question.
Issues such as language barriers and level of education have also been cited by doctors in India as problems they experience in making patients understand what they are signing.
The recent drug trial scare involving six men in the UK was widely publicised, causing an international stir, however, this alarming situation in India is only just beginning to come to light.
While conducting clinical trials in India and other developing countries may seem attractive to a pharma company's bottom line, continuous reports of ethical concerns such as these may eventually do more harm than good if they lead to a consumer backlash.
"This is an incredibly difficult issue, not just in India but in other developing regions such as Latin America that are now being increasingly used for clinical trials," said Kermani.
India's Drug Controller General has publicly acknowledged the problem and has said he is looking into ways at dealing with the issues.
"In Brazil, the regulatory agencies are also now looking closely at how patients are recruited for clinical trials and putting measures in place to monitor this situation," he said.
But it will take some time for the regulatory authorities in these developing nations to catch up with the much higher standards of the West.
In the meantime, the onus is on pharma companies and CROs operating in the region to do all they can to regulate themselves.
"All we can do as an industry right now is try and work together to set up a system where patients don't just blindly go along with trials without being fully aware of what they are doing," said Kermani.