"The court said that before any approval for conducting clinical trials was given, the government should see that it satisfies three parameters of risk versus benefit to the patients, innovation vis-a-vis existing therapeutic option and unmet medical need in the country."
New Delhi, April 21 - Expressing concern over the plight of seriously-affected patients of the clinical trials of new chemical entities, the Supreme Court Monday asked the government to compel the sponsor companies of such trials to pay compensation to such patients.

Why don't you - compel the sponsor - to pay compensation to people who are seriously affected. They may have suffered more than death -, said a bench of Justice R.M.Lodha and Justice Kurian Joseph.

You as a government should act as a facilitator. If you don't have to pay - then see to it that the sponsor - must pay it. We don't know the suffering that seriously-affected patient - is facing, the court observed underling the importance of timely compensation to such people.

Going a step further, Justice Lodha said: Why can't you - as a facilitator make the payment and later recover it from the sponsor -. You constitute a committee which pays and then it is recovered.

Referring to the government's affidavit, Justice Lodha said those who suffered during the course of clinical trials in 2005 or 2006 can't be made to wait for years to get compensation.

They just can't remain waiting for seven to eight years. This is an admitted position that emerges from your affidavit, he told Additional Solicitor General Siddharth Luthra.

The clinical trials of new chemical entities is a stage before such an entity upon verification could be declared as a drug to treat an ailment.

Unnecessary debate must end at your level. You must find ways and means to ensure affected people get the compensation, said Justice Lodha apparently unimpressed by response of the government on the steps taken by it.

The court said that before any approval for conducting clinical trials was given, the government should see that it satisfies three parameters of risk versus benefit to the patients, innovation vis-a-vis existing therapeutic option and unmet medical need in the country.

The court's response came while taking note of a submission by senior counsel Sanjay Parikh appearing for the petitioner - Indore-based NGO Swasthya Adikhar Manch, that the office of the drug controller was issuing approval of the drugs in bulk just in one day. Seeking a comprehensive response from the government, the court adjourned the matter for eight weeks.


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