New drugs are pouring on to the streets of India without having undergone proper clinical trials. That’s what the journal Nature is claiming and it doesn’t surprise me in the least. In fact, welcome to the future. Here’s a quote from the story:
India’s drug-regulatory system is failing in its job, according to a report from an Indian parliamentary committee. The report found evidence that pharmaceutical companies exploit loopholes in Indian law and sometimes collude with the drug-regulatory authority to get licences for their products without adequate tests being done.
The result?
As part of its analysis, the [Indian] parliamentary committee reviewed the approval process for 42 randomly selected drugs, most of which were awarded licences between 2004 and 2010. Documentation for three of the drugs — which the report describes as “controversial” because they are not licensed for use in most Western nations — was missing, and 11 of the remaining 39 had been licensed apparently without undergoing phase III clinical trials.
As I mention in The Fix, Big Pharma is scared of developing psychotropic drugs because so many of them – tranquillisers, anti-depressants, cognitive enhancers – have side-effects that trigger lawsuits. But could the developing world act as a laboratory for testing these medicines?
A point to remember: there are illicit labs all over the developing world which produce fake or rip-off pharmaceutical drugs that cross the medication/recreation barrier. They put pressure on major companies to meet demand (without being sued out of existence, of course). The situation is getting messier by the day.
Here’s an important question. India has a fast-rising population of 1.2 billion. By the time it reaches 2 billion, how many Indians will be taking licit or illicit pills for medical and/or recreational purposes?
Posted in: Drugs, Pills
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