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.
2. 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.