The development of potential therapeutic agents is often complicated by subjective and sometimes objective violations of ethical guidelines.
The development of life-saving medicines is a morass in our country.
While we have a vibrant industry that manufactures generic (copy-cat) drugs, developing innovative therapies has not been our cup of tea.
Development of life-saving medicines often entails balancing the risk to the patient with the projected benefit from using the therapeutic candidate.
In most cases, there is not enough data to make an informed decision, which is not straightforward and requires specialised knowledge and experience.
Using an approved drug that is on the market does not qualify a medical doctor to make such decisions.
Drug development is a separate area of expertise.
While we see green shoots of late, we do not have deep expertise in managing clinical development.
Therefore, we make do with appointing medical doctors to oversee the development of therapeutics.
This requires better guardrails than we have in order to ensure that the basic tenets of ethics are not violated in the process.
The bigger issue in our country is the historic and repeated violation of informed consent when patients are enrolled in clinical studies.
More than anecdotal evidence exists that poor and uneducated people are enrolled in such studies without fully informing them of potential harm from the therapeutic candidate being evaluated in a clinical study.
The job of ensuring such atrocities do not occur falls to what is called an institutional ethics committee.
While such committees exist on paper and in our regulations, their function and effectiveness are at best patchy.
Challenges in Indian Clinical Trials
A recent interventional studies registered in the Clinical Trials Registry–India (CTRI) identified as many as 30 problems with the way in which our ethics committees function
These include clinical trials without any ethics committees, and trials with more sites than functional ethics committees
The simple takeaway from this analysis is that the primary guardrails that are supposed to be a check on abuse of medical ethics do not function in our country.
The biggest abuser of these regulations is a section of the industry that is actively promoted by the Ministry of AYUSH.
The poorly designed, ill-executed “clinical studies” with zero oversight are often used to provide a veneer of scientific validity to their concoctions and nothing more.
Way forward
Even well-designed and well-run systems of checks and balances on accountability are often run roughshod over by those who have the means and power.
We are nowhere even close to how such systems function in the West.
If we truly wish to hold wrongdoing to account, we have a very long way to go before we even get the basics right.
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