In 2013, the approval of new clinical trials in India came close to a halt after a ruling by the Indian Supreme Court and new, tougher regulations — both responding to unethical practices in trials over previous years.
Things now seem set to change. Following industry predictions that clinical trial activity may again increase, the government has stated its intention to rewrite the rules entirely, with reported objectives including “to facilitate the ease of doing business”. And the research community has called for the government to permit types of research not previously used in the country, including first-in-human trials in healthy volunteers.
But India’s experience offers wider lessons relating to the vulnerability of poor and marginalised people recruited in clinical trials. That experience illustrates why vulnerability needs to be recognised as more than a characteristic of particular groups, but as something common to everyone that merits stronger protection of rights. And this ought to be central to our thinking on health, research and justice.