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India becomes global drug trial ground for pharmaceuticals
Published: 19 August, 2010, 08:58
Edited: 23 October, 2010, 14:50
Human rights groups are raising concern over India turning into a hot spot for drug trials, where hospital patients are being used as guinea pigs for the world's pharmaceutical companies, sometimes without consent.
Does India still practice the caste system of classifying people and controlling their opportunities in life? The United States has s similar system called QUOTAS, which is used to play favorites for certain segments of the American population. It is a POLITICALLY CORRECT, phoney system that seeks to categorize the people into racial/ethnic divisions and reward favored categories while ignoring certain other people. Unfortunately, all tax payer's taxes are used to support these give away programs. So the caste system is not foreign to the American system.
It is true that the regulatory systems in India have to mature ,improve and strengthen, but it is wrong to raise alarmist bogey that patients are being treated as guineapigs.Most of the trials in India are currently being grabbed by large corporate,private hospitals in big cities and likewise the pateint poupation being recruited belongs to high caste and upper economic strata. Even in the government hospitals most of the subjects enrolled in the trial are better off in financial and economic terms because they can better understand the nuances of informed consent and trial desisgn.While eagrly awaiting a new lesislation for ovesisght of trials by DCGI and that of Ethics commeettees by ICMR ,it must be sobering to recall that the Contract Research organisations and the Sponsors themselves are bound to take utmost care in ensuring that the code of Good Clinical Practices is adhered to at all site, because the are also ultimately anwerable to various FDAs including the ones in USA and European Union. Anvita
This public health activist "Anand Rai" has this history:
1. Expelled from medical school for criminal charges(a unique distinction for MGM medical college indore)
2. Dean medical school advised psychiatric evaluation
3. Criminal charges still pending in courts of indore.
4. Gained admission in medical school using reservation (belongs to other backward cast)
Characterizes the muck in Indian politics. Corrupt, and criminals only enter politics. Epitomizes "Politics is the last refuge of scoundrels".
luca Valenzin is absolutely correct.Not just drugs but even organs donation is done by the poor for the sake of very little money for their livelihood.People from all over the world flock to the hospitals who do transplantation because here is where you get organs replaced cheaply.Unfortunate and shocking but it is there including drug trials on poor.
It is not a matter of lower cost of conducting a clinicaltrial in India.It rather represent concern of central government to safeguard Indianpopulation from side effect of drugs discovered outside India by making itmandatory to conduct clinical trial in India before giving a marketing approvalas given on page 503 of Drugs and Cosmetics Rules, 1945 and given below.
"(b) for new drug substances discovered in countries other than India,Phase I data as required under items 1, 2, 3, 4, 5 (data from other countries)and 9 of Appendix I should be submitted along with the application. Aftersubmission of Phase I data generated outside Indiato the Licensing Authority, permission may be granted to repeat Phase I trialsand/or to conduct Phase II trials and subsequently Phase III trialsconcurrently with other global trials for that drug. Phase III trials arerequired to be conducted in Indiabefore permission to market the drug in Indiais granted;"
This is analogous to taking a pilot project in various social schemes, to seethe results and if successful, implementing the scheme nationwide, if notsuccessful, terminating the project.
Just think of the situation, if a drug is allowed to be marketed without doinga clinical trial, and if some serious side effect occurs, that would put wholepopulation at risk. We should not forget story of thalidomide which resulted inbirth of childs with shortened limbs
What maybe people do not know is that India does NOT have a public health system; like the US. Therefore poor people are easily targeted and used for experiments. I doubt these experimental drugs are used on high caste people.... I am wrong?