Transnational pharma companies conduct clinical trials in India for monetary gains
Syed Akbar Hyderabad: Transnational pharma companies have been carrying out clinical trialsin India knowing well that Indian clinical trials are not recognised by many developednations including the United States of America. Clinical trials, when successful, areredone in developed nations for approval of drugs. In case of failed results, the pharmacompanies abandon the drug trials. This, in other words, means transnational pharma firms view India as a natural laboratoryfor testing of new drugs and vaccines. With no monetary compensation component forvolunteers in India, the companies prefer the country for all the three phases of humantrials, which involve both healthy people and patients. As the rush for clinical trials (CT) gained momentum in the last three years, the CTindustry in India is now worth Rs 5000 crore. It was just Rs 800 crore three years ago.According to World Health Organisation news bulletin, India along with Pakistan andBangladesh has emerged as the world's preferred destinations for clinical trials. Though the reasons cited, for India emerging as a major attraction for clinical trials,are its highly qualified technical workforce and low costs, pharma companies actuallyprefer the country for patient availability and a "friendly drug-control system." It isthis friendly drug control system that frequently puts economically disadvantaged groupsto high risks of complications associated with new drug tests. The WHO bulletin points out that while it is "good news for India’s economy, the boomingclinical trial industry is raising concerns because of a lack of regulation of privatetrials and the uneven application of requirements for informed consent and proper ethicsreview". According to the FDA, less than 25 per cent of drugs introduced in the last 10 years havebeen breakthrough drugs. About 75 per cent of the new drugs have had only a marginalbenefit or no benefit as ‘add on’ drugs. "Only trials conducted in the randomised controlled trials setting have a proven value indetermining whether or not the drug in question is effective (the best form of evidence).But very few trials in India are done in the randomised setting," regrets senioroncologist Dr P Raghuram. Health researchers point out that most trials in India are undertaken withoutcompensation mechanisms in place. Although the Indian Council of Medical Research hasstrict guidelines relating to compensation mechanism in case of injury or death of thepatient in question participating in the trial, very few trials in India have robustinsurance cover. They demand that research must be part and parcel of medical curriculum in MBBS andpostgraduate training in all medical colleges in the country. Doctors, who have notpublished widely in peer reviewed journals, must not be allowed to participate inclinical trials.