The Campaign for Fighting Diseases, part of the UK-based International Policy Network, says in a report that to remove support for India’s emerging clinical trials industry would be a mistake.
"Although it is not clear if the clinical trials were culpable, should the inquiry suggest new regulations, the real winner will be the Chinese economy rather than Indian patients," write the report's authors, Philip Stevens and Julian Harris.
They suggest that even if wrongdoing is uncovered, the fault will lie in the enforcement of existing regulations, rather than a need to implement new laws.
There were 49 infant deaths reported from trials at the All-India Institute of Medical Sciences in New Delhi. Because contract research is conducted at AIIMS for pharmaceutical companies, the deaths have caused some to question the safety and morality of multinationals conducting clinical trials in India.
Health minister Anbumani Ramadoss is pushing for a government inquiry into the matter, to ensure that poor people are not used as “guinea pigs.”
There is no question that India is a very attractive location for clinical trials, as it has a fast-developing medical infrastructure, and a huge population which has little exposure to pharmacological treatments and is motivated to take part in studies. In addition, there is a large number of English-speaking physicians and scientists – and faster data processing times.
With India already a global powerhouse in pharmaceutical manufacturing, initially focusing on chemical ingredients but latterly moving into secondary production, observers believe it is only a matter of time before a satellite clinical research industry becomes established. Consultancy company McKinsey predicts the sector will be worth $1.5-$2bn by 2010.
One of the key drivers for that is the estimated 60 per cent saving on the expense of running a study in India compared to the USA, where a typical trial costs upwards of $150m. That provides a clear cost-incentive to the industry.
Regulations have already been tightened up to improve standards in clinical research, as part of a wide range of drug industry legislative reforms that came into effect in 2005, bringing the country into line with standards drawn up by the World Health Organization and the International Conference on Harmonization.
Any attempt to add further regulatory restrictions could incite clinical trial firms to shift their attention to China, as well as potentially reduce the number of new medicines becoming available to Indian patients.
“In 2007, the consulting firm AT Kearney ranked China above India as the most attractive location for clinical trials,” according to the report’s authors.
“Like India, it has a vast pool of patients, ethnically distinct groups and a growing respect for intellectual property.”
China joined India as a member of the WHO Clinical Trial Registry Platform in 2007, and is harmonising its regulations to make it more attractive to companies seeking eventual regulatory approval in the US and the EU, they add.