You’ve spent many millions researching a drug and getting it through the licensing process.
Then, after all that hard work and expense, people inconsiderately start dying and suffering serious adverse reactions while on the drug.
It gets so bad (and it has to be really bad for this to happen), the drug regulators finally withdraw your licence.
What do you do? Easy, you start selling to developing countries.
This has just happened with the non-steroidal anti-inflammatory drug (NSAID) nimesulide. The drug has been linked to liver toxicity, and has been refused a licence in United States, Europe, Canada and Australia. Last year, it was banned in Turkey, Finland and Spain.
But it’s good enough for the Indian market, where it has been sold with impunity since 1994, when it was granted a licence. In fact, it’s been quite a success, and isn’t being used just for arthritic conditions, for which it was intended, but is also prescribed as a painkiller and for treating fever.
So how many Indians have been harmed while on the drug? Nobody seems to know, but a committee has been set up to look into it. So that’s alright then.
(Source: British Medical Journal, 2003; 326: 70).