Double standards in quality control?
January 25, 2009
The other day, I stumbled upon this alarming piece of news. In it, the Canadian site raises serious doubts about the safety of “generic drugs” that are being sourced from countries with “few standards and low accountability.”
The report raised several valid points. Yet, I felt amused that the concern stems from a market that often thinks nothing about lowering ethical norms in ordering clinical trials on human “guinea pigs” in India, drawn, as these companies are to the country’s “huge patient pool representing both chronic and infectious diseases, easy recruitment and high cost savings.” But when it comes to consuming the same drugs (an outcome of the clinical studies) suddenly there is a lot of hue and cry about the safety of the drugs!
Do you see evidences of double standards here?
India, you would be surprised to learn is rapidly emerging as a great laboratory for the world, accounting for nearly 2% of the world’s clinical trials and this ‘industry’ is pegged to grow to 5% by 20012.
An RNCOS sponsored report, ‘Booming Clinical Trials Market in India’ notes that parameters such as diverse patient pool, regulatory environment, cost, infrastructure and human resource are big drivers for this industry, although (or because of?) there is still a woeful lack of Good Clinical Practice (GCP), certified sites and investigators, all of which could be extremely dangerous for the Indians volunteers.
The Times of India recently carried a report about laid-off diamond industry workers in the West Indian state Gujarat who have been volunteering for clinical trials to feed their starving families.
Over 85,000 diamond workers in city who have been rendered jobless in the past three months and are now being actively recruited by dozen-odd clinical trial units that have spawned up in the recession-hit state. The testing fetches each volunteer anything between Rs 7,000 to 20,000 per week, which, we beleive, would be enough to keep their home fires burning and then some.
Along with this, you would have also read about the seizure of generic drug consignment off the European ports, where there is increased scrutiny and questions being raised about the quality of these preparations. The latest such seizure was of a consignment heading for the US. The manufacturer was Cipla, one of the largest manufacturers of generic drugs in India. Dr Reddy’s, Sun Pharma and Ranbaxy have also been hauled up in recent months for what the FDA calls “manufacturing deficits.”
The point that I am trying to make here is NOT that control or scrutiny of any chemical composition is bad. That, of course, is needed. My question is merely whether there is also not an equal justification for ensuring safety of the volunteers who are instrumental in getting these drugs manufactured in the first place —- drugs that are so cost-effective that anybody in the US or Europe can afford them. Whether they do it for monetary inducements or a genuine interest in furthering the goals of science is a different matter altogether.
For the record, India is the fourth largest supplier of generic medicines by volume to the US, the world’s largest market that sells generic drugs worth $33 bn annually.
All this begs one question — should ethical norms, good manufacturing practices, quality, and safety issues be concerns only for one part of the outsourcing industry? And if yes, should these norms be different for these two set of population?
The answers to these questions are by no means simple. I look forward to your comments….
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