In December, 2011, Shivraj Singh Chouhan, chief minister of Madhya Pradesh revealed in the central Indian state’s legislative assembly that 233 psychiatric patients in a number of state-run institutions had been used as subjects in a drug trial without their consent. In the next 12 months, a number of them suffered from dementia, lung infections and cardiac arrests. Some also died.
Mr Chouhan’s speech was an important moment, but it was also just one among many cases that highlight the ways in which multinational pharmaceutical companies exploit some of India’s poorest and most vulnerable citizens.
Last year, the market for global clinical trials was valued at more than $44 billion. According to recent studies, it is expected to rise to more than $65bn by 2025. The exact amount it brings to the Indian economy is opaque, but the value of the Indian pharmaceuticals market increased from $20.95bn in 2011 to $27.57bn in 2016. Clinical trials are a major driver in this growth.
Owing to rigorously enforced laws relating to consent, payment and healthcare provision for participants, undertaking clinical trials in the developed world is an expensive and complex process. However, pharmaceutical companies operating in India are able to perform trials at around half of the cost they would accrue in Europe or the US.
This is largely thanks to amendments made in 2005 to India’s Drugs and Cosmetics Act, 1940. The most significant of these changes removed the requirement for the “phase lag” in clinical trials by multinational companies. Previously, global pharmaceutical firms could only launch clinical trials, which are divided into a number of clearly defined phases, in India, if testing had reached a more advanced phase elsewhere.
This rule was meant to prevent large numbers of Indian people being used as guinea pigs by drug companies. Its removal has opened the country up to the testing of chemical compounds that are not approved as drugs anywhere else in the world and whose potential side effects are not yet known. It has also resulted in a multifold rise in the number of clinical trials being carried out in India.
The effects of this upsurge in activity are extremely worrying. A Right to Information response received in late 2017 by the public health advocacy group Swasthya Adhikar Manch shows that nearly 5,000 Indian citizens died during medical trials between January 2005 and September 2017. A further 20,000-plus are reported to have suffered severe health complications. According to the founder of Swasthya Adhikar Manch, only 187 bereaved families have received any form of compensation. Almost all of the victims were poor and from socially marginalised groups.
I began looking into this matter seven years ago. One week after Mr Chouhan made the information about non-consensual testing in Madhya Pradesh public, I visited Indore, the largest city in the state. There, I heard of numerous instances of doctors – encouraged by money and perks from pharmaceutical companies – luring patients into trials with the promise of free treatment and foreign medicine. Several of them died or suffered severe health conditions as a consequence.
In 2010, I went to visit Yatharth Naik, who at two days old had been injected with a vaccine by a local doctor. Yatharth’s father Ajay Naik, who worked as a day labourer, was told by the doctor that the injection would provide immunity against a number of diseases and was being administered free of charge by the Indian government. Within days, Yatharth had developed mysterious white patches all over his skin, which remain to this day. That’s when Mr Naik found out that his son had been used in a clinical trial.
Yatharth was relatively fortunate. A report submitted to the chief secretary of Madhya Pradesh some months later showed that 18 babies had died in the same trial. It was subsequently revealed that doctors had been paid $500 for every child they injected.
In 2012, a parliamentary committee report on health and family welfare claimed that there was an “apparent nexus … between drug manufacturers and many experts” at the Central Drug Standard Control Organisation, India’s national regulatory body for pharmaceuticals and medical devices. Soon after, the Supreme Court directed that no new drug trials be allowed to begin unless they were conducted strictly under Schedule Y of the Drugs and Cosmetics Act.
This meant that the only trials allowed would address specific unmet medical needs in the country, where risk-and-benefit analysis had been conducted, and which related to an innovation pertaining to an existing therapy. Additional amendments also included limiting the number of trials an organisation could undertake in India, mandatory audiovisual recording of the informed consent process and reporting deadlines for serious adverse events experienced by trial participants.
After these regulations were brought in, the number of new trials being performed in India plummeted. But since 2015, following pressure from pharmaceutical companies, many of these changes have been diluted. Now, the requirement for audiovisual recordings of consent procedures only applies to trials involving new chemical compounds or those of HIV and leprosy drugs. As a result, the clinical trials market in India has rallied and new reports of malpractice are surfacing each day.
Ethical clinical trials are, of course, vital to the advancement of medical research, but oversight in India leaves much to be desired. Regulations must once again be strengthened and robust laws introduced to prosecute medical practitioners guilty of breaches. A minimum payment to each participant should also be established and transparency maintained for all trials.
If such measures are not agreed upon and strictly enforced, India will continue to be used as a laboratory for the rest of the world. This cannot be allowed to happen.
Published by The National on October 6, 2018