Ethical issues and violations in medical trials in India

Source: The post ethical issues and violations in medical trials in India has been created, based on the article “Trials, medical ethics and the orbit of power” published in “The Hindu” on 4th July 2024

UPSC Syllabus Topic: GS Paper 2 governance -Issues relating to development and management of Social Sector/Services relating to Health and GS paper 4- Ethics-medical ethics

Context: The article discusses ethical issues and violations in medical trials in India, focusing on informed consent, the effectiveness of ethics committees, and the protection of vulnerable trial participants. It highlights the challenges in upholding medical ethics and the need for stronger oversight and whistleblower protection.

What are the Allegations Against Covaxin’s Clinical Trials?

1. Violation of Informed Consent Procedures: The trials reportedly enrolled participants without adequately informing them about the risks involved, which is a crucial aspect of ethical medical practice.
2. Enrollment of Vulnerable Populations: Vulnerable groups were allegedly targeted for the trials, raising concerns about exploitation.
3. Non-reporting of Adverse Events: It was claimed that adverse reactions during the trial were not reported, which is essential for assessing vaccine safety.
4. Lack of Adequate Monitoring and Follow-up: The trials lacked proper monitoring and follow-up of participants, compromising the integrity and results of the study.

How Do Ethics Committees Function in Clinical Trials?

1. Lack of Oversight: Some clinical trials in India proceed without any ethics committee oversight, as highlighted by the 2022 publication by Gayatri Saberwal et al.
2. Insufficient Committees: The study found instances where the number of trial sites exceeded the number of functional ethics committees, indicating inadequate oversight capacity.
3. Functionality Issues: The same study identified 30 problems related to the operation of ethics committees in India, which suggests significant shortcomings in their effectiveness.
4. Competence Concerns: The effectiveness and competence of ethics committee members were also questioned, particularly during high-profile trials such as those for COVID-19 treatments.

What Role Do Whistleblowers Play?

1. Highlighting Ethical Concerns: Whistleblowers such as Dr. Jacob Puliyel filed writ petitions in the Supreme Court to ensure transparency and accountability in clinical trials, as discussed in connection with the Covaxin trials.
2. Facing Retribution: Despite their crucial role, whistleblowers often face significant personal and professional risks. Individuals like Satyendra Dubey and Shanmugam Manjunath suffered severe consequences for their actions.
3. Legal Weaknesses: In India, the protection for whistleblowers is limited and was further weakened in 2015, reducing their ability to safely report wrongdoing.

What Are the Broader Implications for Drug Development?

1. Ethical Shortcuts: There are concerns with practices such as the “emergency use authorization in clinical trial mode” for Covaxin, which lacks explicit support in the regulatory framework under the Drugs and Cosmetics Act.
2. Lack of Specialized Expertise: The management of complex drug development processes often involves medical practitioners without specific expertise in clinical trials, which can lead to inadequate handling of specialized requirements.
3. Ineffective Oversight by Ethics Committees: Failures in ethics committee oversight are evident, such as approving more trial sites than there are functional committees, leading to compromised ethical standards in trials.

What should be done?

1. Enhance the legal framework to protect individuals who expose unethical practices, similar to stronger protections seen in other countries.
2. Ensure every clinical trial has effective oversight by a competent ethics committee, as gaps in this area lead to ethical violations.
3. Appoint specialists with expertise in clinical trials to manage drug development, avoiding the misuse of general medical knowledge for complex drug approvals.

Question for practice:

Examine the ethical issues and violations in medical trials in India.