Aiming to make clinical trials of drugs safer for humans, the Apex Court has directed the Centre to ensure that pharma companies are made responsible to answer significant questions on each experiment conducted for a new drug.

According to sources, responding to a public interest petition by a non-government organization called Swasthya Adhikar Manch, the Apex Court asked additional Solicitor General Sidharth Luthra for details on compensation paid to patients adversely affected during clinical trial of new drugs.

While the NGO reportedly claimed that in 2012 and 2013, there were around 4,000 cases of severe adverse effects of drugs trial, including deaths, the government claimed the figure stood at 506, with 89 cases of deaths. The Supreme Court passed the order after it found that there were discrepancies in the numbers given by the petitioner NGO and the government.

According to sources, the NGO had alleged that unmonitored clinical trials of new drugs are being carried out by pharma companies on poor people in Madhya Pradesh without their informed consent, putting their health, lives in danger.

The NGO also said that no compensation was paid either by the government to the victims who had suffered injuries or to the kin of those who had died as a consequence of the experiments

The Apex Court suggested that the compensation must be paid jointly by the government and by the companies.


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