In India, the first COVID-19 case was detected on 30th January this year. In the first week of February, Niti Ayog had sent a proposal to all the States to hand over all district hospitals to private parties in the Public-Private Partnership (PPP) model. This shows that there was no focus on strengthening the public health system despite knowing that the pandemic had reached India.
Unethical clinical trials by doctors on patients belonging to all socioeconomic classes have resulted in 5344 deaths and 20,758 Serious Adverse Events (SAE) between 2005 to 2018. Patients undergoing treatment were completely clueless that doctors had used them as clinical research subjects, the worst kind of breach of trust.
Ministry of Health and Family Welfare had issued certain advisories on COVID 19 in February. But there was no urgency in preparing for the pandemic by preparing the public health system. Neither the public hospitals were prepared well nor were necessary logistics arranged. Since then 6 months have passed, and even now the public healthcare system is unable to manage on their own and is heavily dependent on the private sector which remains unregulated. Every state is trying to manage the pandemic using different approaches but the number of cases is going up. If we compare the global test per million data, India is doing far lesser tests than other countries with heavy caseloads. Countries like Brazil are doing better than India. India is doing only 10,664 tests per million, lagging far behind from other heavily impacted countries such as the USA (150,752), Brazil (23000), and Russia (176132) as of 22nd July 2020. Maharashtra, Tamil Nadu, and Delhi are leading with a large number of cases, with Karnataka deteriorating fast.
In the timeframe between June and July, two incidents happened around the issue of the clinical trials. The one on the clinical trial of a drug called Coronil by Patanjali which claimed that they had found a cure for COVID and another on claiming that an Indian vaccine will be launched by 15th August this year.
Before analyzing the recent clinical trial controversies, we need to know what happened in the last 10 years.
Unethical clinical trials by doctors on patients belonging to all socioeconomic classes have resulted in 5344 deaths and 20,758 Serious Adverse Events (SAE) between 2005 to 2018. Patients undergoing treatment were completely clueless that doctors had used them as clinical research subjects, the worst kind of breach of trust. The whole system comprising of doctors, investigators, ethical committees, and the Drug Controller have played with the patient’s right to ethical treatment.
Members of Ethics committees, clinical trial researchers at Vishakhapatnam, Pune, Indore, Jaipur, Bikaner, Ahmedabad, Bhopal, Hyderabad, Mumbai, Delhi, and many other places are still doing unethical clinical trials without due consent or providing necessary information. Thus it is important to view the recent approvals of COVID vaccine trials, immunity boosters, and drugs in the light of these rampant violations that compromise the rights of patients.
Also Read: Health Care Should Always be Available and Affordable – not just during Epidemics (COVID-19)
As per experts, vaccines usually require rounds of trials that may take years as well as time to manufacture at scale. When we look at current global data, a number of vaccines have been in trials for the past months, and those still require until the end of this year to be available to the public at large.
It begs an explanation when ICMR issues instructions to make the Indian vaccine ready for launch by 15th August this year, whereby the first human trial has started only in July.
It came as sudden news when Govt of India announced, in the last week of June, that Bharat Biotech and ICMR have developed an indigenous COVID vaccine and it is set to launch by 15th August followed by clinical trials. While digging deeper into detail, it’s clearly mentioned that participant enrollment for the trials would start by mid-July and all trials will take at least 15 months. But surprisingly ICMR issued a letter asking trial institutions to complete participant’s recruitment before time and hurry up the whole process for an independence day launch. This is completely unscientific and an unethical claim of success when even the first phase of the human trial has not been initiated for the vaccine. There was shock and disbelief at such a claim, and various experts stated that such a feat is impossible and the process of testing a vaccine should be handled with better prudence. Many of the trial sites were pending approval from ethics committees. As of now, the proposed sites are still enrolling trial subjects.
Moving over to COVID drugs in India, there are no less controversies. Recently Glenmark Pharmaceuticals conducted fast track trial of a drug called Fabiflu and claimed that this drug works for patients with co-morbid conditions like hypertension and diabetes. This drug costs almost Rs. 12,500 for a course that is far from the affordability of the poor and middle class. Central Drugs Standard Control Organization (CDSCO) has now demanded clarification on the high price from Glenmark pharma and declared that the claim of efficacy on patients with comorbidity is false and unfounded.
Another controversy involving a claim of an ayurvedic drug that can cure COVID came to light in June. Collector of Indore had approved a clinical trial by Patanjali for a drug to be conducted in MGM medical college, a government medical college. The Drug and Cosmetic Act does not allow a district collector to approve any clinical trials, which is the sole authority of the Drugs Controller General of India (DCGI). As per the Clinical Trial Register of India (CTRI), which keeps detail of all clinical trials in the country, permission was given to conduct trials only in Jaipur. Moreover, this was approved for an immunity booster which was later touted as a cure for the Coronavirus. As Patanjali launched Coronil drug and promoted it as a treatment, various civil society platforms like Jan Swasthya Abhiyan, Rajasthan Nagrik Manch, and Swasthya Adhikar Manch raised these violations.
Ministry of Ayush asked for clarification from Patanjali but has refrained from taking any concrete action.
Both Madhya Pradesh and Rajasthan has history of conducting unethical clinical trials in the recent past.
The legal framework of clinical trials in India is poor and lacks various provisions in the interest of trial subjects such as a strong charter of Patient Rights. A draft charter has been circulated by the Ministry of Health & Family Welfare, however not included as part of the law. It is also silent on the award of a penalty to subjects and criminal action against responsible bodies in circumstances where serious violations are made.
As true for all aspects of public interest, a good democracy needs transparency in research and development as well as adopting a scientific approach while doing new clinical research and trials on COVID 19. India should aspire to high standards of quality ensuring that patient rights are prioritized.
The author is an independent health activist and national co-convener of Jan Swasthya Abhiyan and Swasthya Adhikar Manch