Bhopal (Madhya Pradesh): The Supreme Court has allowed petitioners to file their objections and suggestions regarding the new rules formulated by the Centre for the regulation of new drugs and clinical trials. These rules were initially introduced in 2019, and later amended in 2024 to streamline the approval process for clinical trials and new drugs in India.

The aim of these amendments is to enhance patient safety protocols and ensure adherence to global standards in clinical research. The Madhya Pradesh Economic Offences Wing (EOW) had earlier submitted a detailed report on the unethical drug trials conducted in the state.

Prepared in June 2011 and later placed before the state assembly, the report stated that between 2006 and 2010, 32 persons lost their lives due to illegal clinical trials. Moreover, the report stated that 49 other participants in these trials were left with permanent physical harm after unknowingly volunteering for these experiments.

According to the EOW, the doctors involved in these illegal trials earned approximately Rs. 5.10 crore by conducting 76 clinical trials on 3,307 persons in Indore, without informing them about potential risks.

The NGO Swasthya Adhikar Manch, which filed a Public Interest Litigation (PIL) in 2012, accused multi-national pharmaceutical companies of conducting largescale clinical drug trials across the country, exploiting poor and vulnerable people as "guinea pigs."

The organisation has also raised concerns that the trial victims are not being compensated adequately for their suffering. Amulya Nidhi, convener of Swasthya Adhikar Manch, expressed frustration over the lack of compensation for the victims, stating, “No compensation has been provided to the victims of these unethical drug trials. These cases have been already raised in cities like Indore and Bhopal, with Bhopal gas tragedy survivors also raising their concern regarding the drug trials.”

Bhopal Gas Tragedy survivors too had raised the issue

The issue of unethical clinical drug trials has been raised by survivors of the Bhopal gas tragedy as well. The survivors, who have been subjected to numerous health complications due to the 1984 Bhopal gas leak, also highlighted the illegal drug trials conducted on them without their consent.