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 (government) compel the sponsor (of clinical trials) to pay compensation to people who are seriously affected. They may have suffered more than death (during clinical trials),' 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 (the compensation) then see to it that the sponsor (of clinical trial) must pay it. We don't know the suffering that seriously-affected patient (of clinical trial) 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 (government) as a facilitator make the payment and later recover it from the sponsor (of the clinical trials). 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. (Read: Pharma companies consider leaving India over clinical trial ban)
'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'. (Read: Supreme Court stands firm on clinical trial ban)
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. (Read: Should the government ease norms for clinical trials?)
Illegal Clinical Trials -- India's hall of shame
Earlier the SC had taken the government, NGOs and even the drug regulatory bodies for failing to safeguard people who take part in clinical trials. All this after it emerged that a US-based NGO called PATH (Programme for Appropriate Technology) which tested cervical cancer vaccines on tribal girls. It charged the government with inaction and allowed to carry out illegal trials in the guise of an 'observational project'.
The trials were suspended following the deaths of five girls in Andhra Pradesh, and two deaths in Gujarat in 2009-10 after being administered the HPV vaccines. What is even more shocking is the fact that the vaccines were provided by Merck and GlaxoSmithKline and was in collaboration with the Indian Council of Medical Research (ICMR) the country's apex body for the formulation of biomedical research and was reportedly funded by the Bill and Melinda Gates Foundation!
A parliamentary standing committee noted that the purpose of the tests were simply to promote the commercial interests of the manufacturers who would have made a lot of money if the vaccine was included in the government-run Universal Immunisation Programme.
The panel said in the report that it was a 'serious breach of trust by any entity' and a 'violation of human rights of the girls who were unaware of the implications'. The committee also blamed the head the the Drug Controller General of India (DCGI), the head of the CDSCO because it 'remained a silent spectator even as its own regulations were being violated' while there were also irregularities in the approval of the clinical trials, the import licenses and even the marketing approvals.
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