India’s government may scrap an important compensation rule for human subjects in clinical trials in a bid to placate pharma companies

• In its draft guidelines published in February 2018, India’s drug regulator mandated the upfront payment of 60% of compensation fee if a human subject was found to have suffered a permanent disability or death as a result of a clinical trial.
  
• The payment was to be made within 15 days after a decision was taken by a pre-appointed ‘Ethics Committee’ overseeing the trial, with the remaining 40% of the compensation fee coming within 30 days of the decision.
  
• However, after backlash from pharmaceutical companies and even the World Health Organisation (WHO), the Indian government is considering a plan to scrap the compensation clause.
  

When India’s Central Drugs Standard Control Organization (CDSCO), the national drug regulator, released the draft guidelines for laws on new drugs and clinical trials in February 2018, it included an important compensation clause to protect human subjects.

The clause mandated that a sponsor of a clinical trial would have to pay upfront 60% of the compensation fee if a human subject was found to have suffered a permanent disability or death as a result of the trial. The payment was to be made within 15 days after a decision was taken by a pre-appointed Ethics Committee overseeing the trial, with the remaining 40% of the compensation fee coming within 30 days of the decision.

However, after backlash from pharmaceutical companies and even the World Health Organisation (WHO), the Indian government is considering a plan to scrap the compensation clause, an official told Indian Express.

In July, the WHO asked India’s health ministry to reconsider the compensation rule because if approved, it would discourage pharmaceutical companies as well as the WHO from conducting clinical trials in India.

The agency explained that the appointment of the seven-member ethics committee by the Indian government was not in line with international best practices, and would raise questions about their competence. Similar sentiments were also echoed by the Indian Council of Medical Research (ICMR).

The issue of speedy compensation for people affected in drug trials is a particularly contentious one.

Out of the nearly 5,000 deaths that have resulted from clinical trials between January 2006 and November 2017, compensation has been afforded to the kin of only 187 participants, according to an RTI request filed by the Swasthya Adhikar Manch, an Indore-based NGO.

The Indian government knows that clinical trials are key to supporting homegrown research and innovation in the pharma sector. However, if it eventually scraps the compensation clause, it will have to introduce an adequate clause that protects the rights of trial participants. If not, this will likely be seen as another case of the government giving into the pressure from big business at the expense of its citizens’ interests.

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