Demand for bringing clinical trials in the public domain

About 20 people fell ill in Rajasthan after being given an orthopaedic drug

May 04, 2018 10:54 pm | Updated 10:54 pm IST - JAIPUR

The Rajasthan Nagrik Manch and Swasthya Adhikar Manch have demanded that all clinical trials conducted in the State between 2005 and 2018 be made public and their results and health impact revealed.

The demand has been raised in the wake of claims by about 20 persons that they were subjected to “unethical trials” without their consent in a private hospital in Jaipur.

About 20 labourers from villages of Churu and Bharatpur districts were reportedly administered an osteopathic-orthopaedic drug here on April 20 in an alleged instance of unethical clinical testing. When the health of some of them deteriorated, the villagers said they were given the medicine on the pretext of treatment for indigestion. The hospital has refuted the allegation.

The activist groups working in the health sector said here on Friday that though some of the victims of trial were yet to recover from the adverse side effects, the State government’s Medical and Health Department had failed to do their health check-up.

Detailed information

“The Supreme Court has directed that those taking part in clinical trials are to be provided with detailed written information about the trial, including the risk involved in participation and their right to withdraw anytime during the trial,” Nagrik Manch general secretary Basant Haryana said.

The two groups, supported by the National Alliance of People's Movements (NAPM), asked if the delay in action against the hospital was meant to protect the guilty.

CDSCO report

The Central Drugs Standard Control Organisation, which is investigating into the Jaipur case, is yet to make its report public.

In an ealier case, the State government had acknowledged in an affidavit filed in the Supreme Court that there were 386 “adverse health events”, including 95 deaths, due to clinical trials which took place between 2005 and 2012. While demanding that all clinical trials be made public, Mr. Haryana said 214 trials were currently being conducted in the State, mostly in Jaipur and Bikaner districts.

The two activist groups demanded proper treatment and compensation to the victims, immediate registration of criminal cases against the hospital management and guilty doctors and an independent inquiry into all ongoing trials in the State.

The Jan Swasthya Abhiyan has also demanded rigorous monitoring of the centres where clinical trials are conducted, while affirming that poor and uneducated people were often coerced to become the objects of tests for paltry sums of money and subjected to adverse consequences without being compensated for them.

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