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Ethical violations and the regulation of clinical trials UPSC NOTE


  • 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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Learnerz IAS | Concept oriented UPSC Classes in Malayalam: Ethical violations and the regulation of clinical trials UPSC NOTE
Ethical violations and the regulation of clinical trials UPSC NOTE
Learnerz IAS | Concept oriented UPSC Classes in Malayalam
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