India’s government is contemplating suing my coauthors and I for defamation for some research we published last month. In our National Bureau of Economic Research working paper on the quality of Indian medicines exported to Africa we concluded that poorer quality products were intentionally being sent to Africa because of the continents generally weak oversight of drug quality. Litigation is rarely an effective method of finding the truth, more often a process to limit investigations and hide the truth, especially when those threatening have problems with jurisdiction, standing and no case at all. But the obvious indignation of many well-educated Indians made me think that there could well be folks within the Indian government and even Indian industry that have absolutely no idea of the problems its Industry has.
Assuming the data we presented in our NBER paper are accurate, is there a possible explanation for the bold-faced denial of leading Indian commentators? One possibility is that Indian companies actually do largely follow good practices, but still make some even many bad products.
Suppose a company follows decent pharmaceutical practices in formulating medicines, one could still make an inferior medicine if the ingredients were incorrect in some way. If you’re using a regular supplier, one you’ve used for years, you might have initially tested what they sent, but after a while decided to limit or cut testing in order to save costs. In such a way inferior, incorrect or generally sub-par ingredients could be used in otherwise correct formulations.
In fact your regular supplier may not have changed its practices either, but the practices of another intermediary they buy from may have changed. The world of pharmaceutical chemical supply is convoluted and largely ignored by drug regulators. Customs agents pay attention to what is transported but only to the extent that paperwork demanded is complied with – in many places the paperwork doesn’t have to be accurate. Even when it is exposed as incorrect many customs agents have neither the incentive nor the ability to follow up. If a criminal act has been exposed, or trade in a dangerous (immediately toxic or explosive) product, has been exposed then customs agents in most parts of the world will act. But many ingredients for drugs are inert and never immediately dangerous, and paperwork irregularities for such products are a low priority for customs agents.
My research in Asia and the Middle East over the past decade culminated in several papers and books documenting some of the flaws in the intermediary stage (see most recently this article with links). Ignoring flagrant criminal action such as cargo theft, most problems for drug quality come from inaccurate paperwork, sometimes flagrant fraud. For example I saw a bill of lading indicating that chemicals had originated in Italy, when they had been processed somewhere in China. Presumably one of the reasons for passing off Chinese chemicals as Italian, is because of the latter’s better reputation for quality. Italy remains one of the largest producers of active pharmaceutical ingredients in the world. If Chinese production is of Italian quality then there will be no problem, but if the ingredients were inferior in some way, and an Indian firm is buying what appears to be good value Italian chemicals that are no such thing, then correct production could take place in India, but an inferior medicine being produced. At that stage, assuming testing is undertaken the problem may be unearthed, but it may not. Perhaps the product is entirely fine in good storage conditions but is unstable at higher temperatures or humidity – conditions that may exist in Africa. In such a way inferior products may end up being consumed in Africa with few errors from the Indian producer, and certainly no intent to export inferior products.
Investigating deeper into the middle of drug supply chains is not straightforward, but it may be vital if we are to root out substandard medicines. Companies have to secure up those parts of the chain that others cannot follow easily. If they don’t they will continue to hear bad news about their products, and potentially damaging economic consequences to them and devastating consequences to patients.