SC seeks details of cash relief to drug trial victims

Health ministry told to file reply in four weeks

The Supreme Court on Monday asked the Centre to explain if it was adhering to safety norms while allowing testing of the new chemical entities.

The apex court also asked the government how it proposed to compensate those who suffered serious adverse effects during clinical trials.

A bench of Justices R M Lodha and Kurian Joseph expressed concern after being told that out 506 cases of serious adverse effects on the subjects of clinical trials, there was no information about compensation paid to any of the victims, even though money was paid in case of 89 deaths.

The court asked the Health Ministry to file an affidavit within four weeks about the quantum of compensation to be paid to such victims.

Appearing for the petitioner, Swasthya Adhikar Manch, an NGO, senior advocate Sanjay Parikh contended that the Health Ministry has not been forthcoming about details regarding the approvals granted to new chemical entities.

He also submitted that it failed to furnish details if the approvals granted by the technical committee and the apex committee only after considering the three parameters of safety and efficacy, particularly in terms of risk and benefit to patient; innovation vis-à-vis existent therapeutic option; and unmet need in the country.

The three parameters were ordered to be followed by the apex court on October 21.
The apex court also sought the government’s response on the submission regarding non-adherence of the parameters within four weeks.

During the hearing, the court asked the ministry to inform about the impact of the testing of new chemical entities between January and December, 2013, including death and serious adverse effects on the subjects of clinical trials.

The court asked the ministry to respond to an application alleging that 215 Bhopal gas victims who were subjects of clinical trials were not paid the requisite compensation, and that the Serious Adverse Events (SAEs), including death, were not reported in time.

The petitioners also raised the point that the technical committee included Dr Ranjit Roy Choudhary, who is the Chairman of task force for research in Apollo Hospital, which has conducted 300 clinical trials, including multicentre global trials, on behalf of multinational pharmaceutical companies.

In spite of this being a clear case of conflict of interest, he was still selected to be a member of the technical committee, they claimed.

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