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.
