Humans as guinea pigs: Whither systemic changes, transparency, accountability?

By Anushree Naik* 
The struggle with illegal clinical trials and their cryptic impact on the victims, their families has been long drawn. The battle began somewhere around 1995. Clinical trials are the testing of drugs that happen on research participants, known as subjects, as a part of clinical research by pharmaceutical companies or a health tech companies.
Government agencies and regulations and laws are supposed to regulate the execution of these tests throughout a definite process. Ethics committees is responsible for monitoring the process. These ethics committees have to register themselves with the government.
Stage I of the clinical trials in India lasted up to 2005. It was the time when India had a ‘Phase Lag’ policy. The ‘Phase Lag’ policy specified that all the clinical research in India should begin at its first phase. These mandated foreign countries coming to India for clinical trials to begin their process in India itself. It ensured more authenticity and transparency.
The next stage was the duration from 2005 to 2010. This was the time when radical provisions and progressive laws were introduced in India. In 2005 the provisions of the Phase Lag policy were relaxed. This meant that foreign companies could start the clinical research outside India and come to India in some of the intermediate phases of the research, test the drug/vaccine on the Indian public.
This new rule lacked transparency. The cost of conducting trials outside India had been very high, and it was expensive to pay compensation to every subject, hence foreign companies came to India for this process. When the public demanded information on these trials, the government denied revealing the same on the grounds of confidentiality. Thus the entire process lacked accountability.
In 2009, the Central Drugs Standard Control Organization mandated the clinical researchers in India to preregister in the Clinical Trials Registry of India before enrolling any research participants.
In 2010 the anti-clinical trials movement began and more and more people started questioning the legality of clinical research in India. But this was also the time when clinical trials were happening on a large scale without the knowledge of the subjects.
There was no regulatory framework, no consent taken from the subjects/participants of the trials, no or fake ethics committee monitoring the process, and mass exploitation by clinical researchers as no fixed compensation was decided. The consent form was printed only in English, making it difficult for the subjects to understand what they were enrolling for.
After two years, a legal request for an investigation was put forth, and subjects were interviewed. The anti-clinical trials movement moved from a text book issue to a more realistic one. Common men revolted. It shifted from a doctor-centric issue to an expert-centric issue. These experts were the ones who had studied the entire history and existing scenario in detail.
In 2012, the media exposed the dark reality and truth behind unregulated clinical trials. Social workers received support from the media channels. Leaders of opposition parties showed some support when the government refused to reply to the appeals of the mass leaders.
The movement gained traction when the victims came together along with the big media and communication houses all over the country. That is when the judiciary intervened, and the state assembly passed the appeal of investigation. The success of this campaign was due to mass public mobilization.
From 2013 to 2016, efforts were made to regularize the clinical trials process. Certain systemic changes brought transparency and accountability to clinical research. The official registration of ethics committees started, the video recording of the trials was made compulsory, there were specific rights given to the subjects.

Social activists have demanded disclosure of information on vaccine trials.  They are awaiting reply for information filed by RTI

In 2013, a law for compensation of the subjects was also passed. But certain pleas regarding retrospective compensation are still pending in the court of law. In 2019, the government enacted the New drugs and clinical trials rules 2019 which provided more guidance on how the ethics committee of a clinical trial should monitor and review it.
The Covishield vaccine trials were in the limelight in 2020. Social workers including Amulya Nidhi of the health rights NGO Jan Swasthya Abhiyan filed an affidavit demanding disclosure of information on the vaccine trials of Covishield. But the urgency and chaos of the pandemic did not allow the social workers to push this concern strongly. They are awaiting reply on their request for information filed by a Right to Information (RTI).

Fight against silicosis

Another concern that has been a long drawn struggle is that of the fight against silicosis. Silicosis is an occupational health hazard caused by inhaling tiny particles of silica that eventually get trapped in the lungs. Silicosis was for a very long time misjudged and misdiagnosed to be tuberculosis or pneumonia.
Taking advantage of this, the medical practitioners often diagnosed it as TB on purpose to negate any suspicion on an occupational hazard. Hence the official numbers of Silicosis cases have consistently been underreported.
When the deaths in Madhya Pradesh due to lung diseases increased tremendously, people demanded an investigation of the people dying of lung diseases. The medical practitioners had to cut open the lungs to find out fine silica powder in there. They called it the ‘Safed Dhul Ki Bimari’ and that is when the cause of the deaths was established.
Madhya Pradesh later had 480+ confirmed silicosis cases. In 2009 the Supreme Court finally passed the law for compensating the victims of Silicosis. This was only possible when the medical researchers confirmed of Silicosis on examining the Xray of lungs. This was a people-driven movement. It wasn't easy to shift the onus from TB to silicosis.
This movement spread in many states of India, including Maharashtra and Gujarat. Since most of the affected person's were migrant workers, there wasn’t any mechanism to identify them. Moreover the anonymized employees were unaware of this causality.
But legal intervention and the continuous support of media enabled establishing a systematic preventive and remedial procedure to curb Silicosis cases in India. The preventive measures included mandating pollution survey and a dust survey before employing people at the site. It also included identifying the illegal sites, conducting annual health check-ups at the camps and executing occupational health programmes.
The remedial measures included rehabilitation of the employees and their families, paying them compensation, etc. These were implemented by conducting a village-level mobilization activity. Thus a long-drawn struggle of 10 years finally culminated in fixating Rs. 3 Lakh compensation (Now Rs 5 lakh) to more than 550 workers as a part of their rehabilitation.
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*Second Year Student of the Post Graduate Programme in Management at IIM Ahmedabad. Based on interview with Amulya Nidhi. For secondary sources click here, here and here