Shameful complicity

The Supreme Court has again had to intervene to ensure payment of rightful and adequate payment of compensation to victims of clinical trials conducted by pharmaceutical companies, mainly multinationals, in India.

It has instructed that sponsors of trials held in 2005 should pay immediate compensation to those who suffered adverse medical effects because of the trial.

It is surprising that they had to wait for so long for this. The matter had to be raised in the court by a non-government organisation which pointed out that Indians are used as guinea pigs by foreign pharmaceutical majors for human trials of new drugs.

It pointed out that the companies have not followed up the matter of consequences and compensation for victims and the court has taken the matter seriously.

The court pulled up the government for its inaction on the matter.

According to the figures presented by the government to the court, 11,972 cases of adverse medical consequences of clinical trials were reported during the period from 2005 to 2012.

These did not include 80 deaths which were attributed to trials. In fact there were inconsistencies in the figures and the court has asked for more details.

Though the kin of 80 persons who died were compensated, the living victims were left in the lurch.

The court noted that the patients who suffered serious adverse effects may be suffering more than those who died.

The government could only submit that it had not seriously looked into the matter. This only shows lack of responsibility in protecting the interests of vulnerable people who become subjects of trials.

Most of them are poor and illiterate and are not aware of the consequences of the trials. Informed consent is meaningless in such cases.

Though a regulatory framework is in place for clinical trials they are not implemented effectively.

The petition has sought more stringent guidelines and safeguards for conducting such trials in India.

It has also been proposed that trials should be allowed only if the drugs which are being tested are needed in India.

Other criteria like the extent of risk involved and availability of safe alternatives should also be considerations.

While there is a case for improving the rules, their implementation is more important.

The problem lies in a nexus between the authorities and the companies which conduct the trials. Inaction and indifference are a part of that nexus.

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