June 19: Transnational pharma companies have been carrying out clinical trials in India knowing well that Indian clinical trials are not recognised by many developed nations including the USA.
Clinical trials, when successful, are redone in developed nations for quick approval of drugs. In case of failed results, the pharma companies abandon the drug trials midway, leaving behind Indian “volunteers” to suffer from the after-effects of the drugs.
India along with Pakistan and Bangladesh have emerged as the preferred destination for clinical trials, according to the WHO news bulletin.
As the rush for clinical trials (CT) gained pace in the last three years, the CT industry in India is now worth Rs 5000 crore. It was just Rs 800 crore three years ago. Though highly qualified technical workforce and low costs are cited for attracting drug firms, it is the patient availability (both healthy and patients) and a “friendly drug-control system” which gives India the edge.
The WHO bulletin points out that while it is “good news for India’s economy, the booming clinical trial industry is raising concerns because of a lack of regulation of private trials and the uneven application of requirements for informed consent and proper ethics review”. “Only trials conducted in the randomised controlled trials setting have a proven value in determining whether or not the drug in question is effective (the best form of evidence). But very few trials in India follow,” regrets senior oncologist, Dr P. Raghuram.
Health researchers point out that most trials in India are undertaken without compensation mechanisms in place, though the Indian Council of Medical Research has strict guidelines in place.
