India’s journey towards Ethical Clinical Research

Amulya-Nidhi

By Tanmay Lad (MBA student from IIM Ahmedabad)

Since the emergence of the COVID-19 pandemic, all eyes have been set upon the development of a successful vaccine that could take humankind out of the socio-economic crisis. On Jan 16, 2021, India launched the world’s largest vaccination program amid clinical trial allegations. Several trial participants, most of them being illiterate, had come forward against unethical practices during COVID-19 vaccine trials about lack of proper consent and unavailability of reporting mechanism in case of adverse effects. But this is not very surprising considering India’s history of irregularities in clinical trials.

Though humankind has benefitted greatly due to advancement for knowledge in the medical science field, risks associated with the same cannot be ignored. And in India, many had suffered due to the darker side of the coin. India’s journey of clinical trials started in 2005 by removing the Phase with amendments to the Drug and Cosmetics Rules of 1945 and Patent Bill of 1970. This attracted many international pharmaceutical companies to India. But the weak regulatory system was still based on the archaic Drugs and Cosmetics Act, 1940 and allowed many pharmaceutical companies to exploit the ‘subjects’ who were generally poor and illiterate. As opposed to the developed world, where it was difficult to recruit the patients and involved higher costs of operations and clinical care, India was proving to be a very attractive destination to carry these experiments. This was mainly due to multiple factors such as lower costs, easy availability of a large number of patients due to unawareness, and fewer regulatory hurdles. This continued for several years, taking many precious lives until Swasthya Adhikar Manch (SAM) led the initiative and forced the apex court to intervene in the matter. Let us look closely into their journey to make India move towards adopting ethical practices in medical research.

The city of Indore came into the limelight for the wrong reasons in 2004-10. During the period, around 73 clinical trials were conducted on more than 3,300 patients (or “subjects’ as they are referred to in the medical world), including 1,833 children. These trials were sponsored by multiple multinational pharmaceutical companies for the treatment of many diseases, including epilepsy, heart failure, depression, and schizophrenia. The majority of these subjects were illiterate, and their thumbprints were taken on the consent forms written in English. About the medicines, they were told that these new imported medicines were made available to them by a charity foundation by the doctors – who those people saw as a god. As many as 81 suffered serious adverse events and deaths in which 33  lost their lives. When this was reported by a local Hindi daily newspaper, along with a team of medical doctors and activists, questions were raised in state assembly and investigation was initiated by the Government. Dr Anand Rai had filed initial complaints which were later followed by Veejay Chaudhary, Paras Saklecha and many others. This was a meagre amount compared to the payment of Rs. 5 crores that 6 of the doctors had received from the pharmaceutical companies. Amulya Nidhi and his organization SAM pursued this matter further. They lodged a complaint against practitioners at the Medical Council of India, which resulted in a temporary suspension of the license of these doctors.

But it wasn’t that simple for activists like Amulya Nidhi and his organization since the issue ran much deeper. It wasn’t just doctors who were at fault; there were multiple bad actors who they had to fight to seek justice. All the stakeholders, including regulatory agencies, ethics committees, drug testing laboratories, pharmaceutical companies, contract research organizations (CROs), and doctors, were aware of the trials and their implications except the subjects themselves! Regulators, investigators, and sponsors had formed nexus while CROs were unregulated. Doctors also had vested interest in the process, were often sponsored with lavish foreign trips or received a hefty amount of money.

Not only in Indore, but there was a downright violation of patients’ rights across the country. In Bhopal, clinical trials were conducted on the victims of the 1984 gas tragedy, and 14 of them had perished due to side effects of the drugs. The Bhopal Memorial Hospital made more than Rs. 1 crore from pharma companies, but no action was taken against the doctors in this case. In another case, around 24,000 adolescent girls were given HPV vaccine trials in Gujarat and Andhra Pradesh in 2009. All this was done without informed consent, where the form was signed by the hostel warden. Many girls suffered from adverse effects, while 7 succumbed to the side effects.

Coming back to the Indore case, SAM filed many complaints and RTIs, but much of the data was never made public. Doctors and other concerned parties refused to cooperate, citing confidentiality of the process for obvious reasons. Since these impediments made it difficult to get evidence, they had to interact with the families involved in the clinical trials extensively and spread awareness among the common public regarding the issue. They launched a public campaign and published materials and evidence on their website to spread awareness through digital media. But they eventually had to close it down since pharmaceutical companies used these documents against the activists by spreading false accusations. Some of the pharma companies’ stakeholders even labelled them as anti-development, while some multinational pharmaceutical giants highlighted the statements against them. And this was despite the fact that some of the vaccines or medicines being tested were relevant for diseases not generally found in India; the poor subjects were essentially just guinea pigs for the western corporates.

The team at SAM persevered with the fight for justice until the apex court took notice of their PIL petition in 2013. The Supreme Court censured the government for its failure regarding the issue. It suspended all clinical trial approvals by the Drug Controller General of India (DCGI) until a monitoring mechanism is set up to control the process. Based on the recommendations of 59th parliamentary committee report, the Ministry of Health and Family Welfare (MHFW) and Central Drugs Standard Control Organization (CDSCO) amended existing laws and regulations which included reporting mechanism of serious adverse events, compensating subjects in case of injury/death, mandating informed consent, improving approval process, etc. The event defined a chapter in India’s journey towards making medical science more ethical. After the establishment of new rules, India witnessed a steep decline in the applications as well as approvals for clinical trials, declining by 67% from 253 in 2013 to 83 in 2016. This was mainly due to the issues related to implementing rules and frequent changes by the government. And the corporates were clearly not happy with this. Kiran Mazumdar-Shaw of Biocon called it “a black day for Indian science and a sad reflection on the judiciary”!

Nonetheless, SAM continued its efforts and submitted its suggestions to the parliamentary committee. In this judicial activism the crucial role played by Senior advocate Sanjay Parikh, who fought this case in the supreme court, played a crucial role in this judicial activism.  The government accepted half of their recommendations and introduced the New Drugs and Clinical Trials (NDCT) rules in 2019. New rules aimed at promoting clinical research in the country by putting in place transparent and effective approval and regulation processes and at the same time empowered ethics committee. According to Amulya Nidhi of SAM, the battle is still far from being won, though. The new law ignores the rights of the subjects as recommended by National Human Rights Commission and still lacks transparency in the clinical trials process. Since 2013, more than 5,000 people have lost their lives, and around 20,700 suffered through serious events while a mere 244 were compensated for the loss.

As we rush to get inoculated to save ourselves from the prevailing pandemic, we must be cognizant of what happens behind the scenes for the development of these vaccines. I would like to close with a beautiful poem by Amulya Nidhi on the plights of victims:

गम है अनगिनत मौतों का

डर है इनको गिनने का

न जाने कितनी हक़ीक़त

मिट्टी में दब गई

पानी में बह गई

रह गई वो राख

वो कब्र

और वो फोटो

जो पुकार के कह रही

अब बस भी करो सरकार

– अमूल्य निधि

This article is based on the interview with Amulya Nidhi, health activist and founder and national co-convener of Swathya Adhikar Manch. He has played a pivotal role in winning the Silicosis case and the Clinical Trials case in Supreme Court. He is currently working on Primary Health Care in India.

Written by Tanmay Lad, a post-graduate student at IIM Ahmedabad.

External sources used:

https://www.drishtiias.com/to-the-points/Paper2/drugs-and-clinical-trials-rules-2019

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