Drug Quality in the Developing World

Good morning, it's a pleasure to be here with you today to begin this discussion on the fight against dangerous medicines. I'm going to discuss my recent paper on Indian drug quality, but will also range wider and won't need my time on the panel.

For at least the past five years this has been the topic which has interested me more than any other and I always enjoy the chance to talk about it. I should start by saying that my general approach to the subject has been from the stance of public health rather than being first interested in breaches of various intellectual property rights. So I've analyzed medicines which are substandard or otherwise seen as clinically inappropriate, to estimate what the market for these drugs is, and am searching the proximate and ultimate causes of quality failures. Of course the overlap with breaches of IP are often significant, but not always where you'd expect nor as often as you may think. And so the research project I'm leading is trying to find ALL the causes of substandard medicines.

I sometimes think we have more uncertainty than we need because of lack of research and we do things simply out of inertia and without good reason, which exacerbate problems with allies like India.

I stress this because this is a very immature topic of study and I'd argue that I'm only just getting to grips with the causes, some which may be universal others which are very local. I say this, of course, as a self-interested researcher, but it is interesting to see how many policy decisions are made on such truly woeful and often non-existent data.

Don't get me wrong I'm always happy to weigh in on immediate policy or practical solutions and realize policy has to be set within a framework of uncertainty. It's just I sometimes think we have more uncertainty than we need because of lack of research and we do things simply out of inertia and without good reason, which exacerbate problems with allies like India.

As we all know, pharmaceuticals have enormous potential to improve the health of citizens across the world, but too many life saving drugs in the markets of developing countries are ineffective. As the slide shows these drugs may be counterfeits (mislabeled products, possibly with no API or maybe expired products repackaged); or they may be substandard, legal products just made badly, or which have deteriorated in distribution and storage. Some people want to focus only on the labeling infractions (trademark concerns--saying the blue is non-existent, there are no good quality fakes), apparently assuming non-counterfeit substandards are rare or unimportant (that is the pink), others take a counter position saying we should only focus on substandards, saying some trademark violators make good standard products--the blue is large in their eyes.

There is much to disagree about, at least in terms of the importance of each segment and the issue is complex and replete with paradoxes. And nowhere are these better illustrated than in India.

The title of my publicized talk refers to a paper published last week with several coauthors on some limited assessments of drug quality in India. This is part of an ongoing assessment of essential drug quality from a variety of countries, where my aim is to further understanding of the causes of all types of substandard drugs. Indian entities are slap bang in the middle of all of this ... perpetrators, victims, conduits.

Take this slide looking at an Indian generic antibiotic (colleagues bought these at a pharmacy in Lagos--it is a cipro product, apparently a top brand in Nigeria--the good contains cipro, the bad a mix of talcum powder and other compounds).

So the Indian company as victim here, but in this next slide we see headlines from Indian newspapers attesting that Indian patients can also be victims of Indian companies, albeit companies which break the law.

Over the past two years my research team have been sampling drugs from India, some of the results were reported last year in the peer review literature, , others just reported in the policy paper published last week, pdf can be pulled from online, or I believe picked up here today.

This is what we've found.

We sampled five essential drugs, for treating bacterial infections, TB and malaria.

The covert shoppers were nationals of the city in question. I didn't buy any drugs, a white foreigner would certainly bias the sample.

The results varied but we found that on average about 8% of drugs from 52 pharmacies failed at least one test, often more than one--all drugs failed roughly equally, easily within on standard deviation, whereas the pharmacies failures occurred in were more varied. The pharmacies in Chennai did better than in Delhi. We found that the majority of the pharmacies traded in high quality and remarkably cheap products, but a sizeable minority were trading in products which failed basic quality tests for active ingredient, failures were confirmed by the use of a raman spectrometer (the same spectrometer where we generated the spectra of that Indian ciprotab).

In this next slide one can see how the pharmacies did in each city, 2 poor in Chennai, many more in Delhi.

We also tested from a few wholesalers, the results whowed slightly lower failure rates than from the pharmacies.

I'm still analyzing the products we procured, (which is why there are no photos of these products), but it's fair to say that many of the drugs that failed quality tests were expired products that had been relabeled. Some other products appear to be entirely legitimate, they were either made with poor API or have been stored very badly. The sample sizes were pretty small and I'd be the last person to say they "represent" the state of the problem for the cities sampled, let alone the whole of India, but I think these data are indicative that there are myriad problems (we are not sure of the scale of course), some sloppy production and storage as well as the more widely advertised criminal activity--especially when backed up by the numerous media reports of illegal activity and drug adulteration going on (which are discussed in the report and I showed some of the related newspaper headlines earlier).

Perhaps as interesting as the drug quality findings are the reactions of the pharmacists we spoke too--for example nearly every one of the pharmacists in Delhi, that is 24 out of 26, said they had been offered fake drugs at some time or other. To me this is evidence of a thriving and overt market in fake products, if small by comparison with the mainstream distribution. And given that wholesalers had problems, poor quality is not solely a problem of bad action by pharmacists.

So why do these multiple quality problems exist? Ignoring criminal action for a second, why, as it appears, is there poor API being used, why are storage conditions so bad, why are expired products not being destroyed (or expired packaging not being destroyed even if the drugs are. Overall why is good practice not followed?

I have my opinions but it's not easy to tease out the various causes, other than the obvious ones (poverty and illiteracy). But are these things that can simply be improved in India quickly?.

If one looks at the history of drug development and oversight in US, it is not one story but a series of events (catastrophes would be the emotive word), legislation and increasing quality over the best part of a century. In my opinion there are some processes, maybe even those events/catastrophes, that all developing nations will have to go through, before they reach the overall quality in US.

America has had its pharma criminals and probably still has a few, but India appears to have a lot. I hypothesize that the reason Delhi has a more than double failure rate of Chennai is because it is in the North where production of fakes is known to be worse, in particular it is surrounded by Haryana and UP. More people have focused on this than the substandard question and we have more answers.

Until recently India had weak laws against counterfeiting of drugs. And while in recent times India has put the laws in place to make the faking of drugs a serious offence, it has yet to deal with the corruption which makes inaction at the state level widespread.

For example, how can counterfeiters be caught on film (as Pavel Garg of Haryana State, bordering Delhi, was by the BBC) describing their bribery of state officials yet still be at large practicing their odious trade (as I was told last week was still the case). If the Federal Government were truly serious they'd take action.

But even when someone is caught, legal redress is still interminably slow to the extent that much of the legal system acts as a preventative to removing any threats. The result is that every kind of bad drug imaginable is available across India--perhaps the most shocking is ineffective anesthetics leading to patients awakening in the midst of major operations.

It is first and foremost vital that these major problems are exposed--hence part of the reason for this paper. Which makes it of concern that the Indian government started leaking statistics 8 months ago saying that they basically didn't have a problem (11 fake samples out of 24,000 I believe it was), but the Indian Government is still to actually release the detail behind these figures. This is something we've called for from the Government, and I'd be interested to hear from those who've met recently with the Indian Government whether this has been addressed. After all, and I think this applies to every one working on this topic ... . nothing good is likely to come without transparency--especially on a topic so ill understood.

For while we know some things that need to be improved, and not just in India, we must encourage these to be done without undermining the great role the very good Indian generic drugmakers can play for the world's poor. They make very cheap drugs very well and we must ensure not to damage these companies when targeting the bad players in the Indian market

And there are self-interested reasons for doing so--major fights with India will not be resolved until some bigger picture concerns are acknowledged and addressed.

For at least the past decade I've watched and commentated on the often fierce debate about intellectual property rights and access to medicines in poorer nations. This debate is replete with obfuscation and thinly veiled vested interests. Most of the time the alleged solutions have been anything but that. They've been useful, sometimes sensible, but primarily useful, arrangements for the respective players concerned. The path of least resistance has usually been chosen, whether we'd like to admit it or not.

We know about the vacillating positions of Brazil and India over IP enforcement but we should think about the policies and programs western governments and companies have put in place over the past decade and acknowledge when they have not been suitable or beneficial and why that has been the case. If we don't I doubt we will resolve the issues under discussion today, at least not for the foreseeable future.

What am I talking about? Well East African anticounterfeit legislation arguably conflates generics with counterfeits and seems to have been encouraged by IP interests from EU. Also EU generic drug seizures--plays into powerful elements in India and Brazil that see all such moves as being at the behest of the pharma industry I couldn't get a straight answer from the European DG for Trade about who has been prosecuted for importing these allegedly IP infringing products ... Even if these seizures can be seen as an acceptable application of IP law by the specific member state they are unhelpful in the grand scheme of things.

Am I overstating things? Well I didn't see much movement on these differences at last weeks World Health Assembly. Reading the US and Indian texts and the final texts of the meeting on language about counterfeiting definitions I see little hope of movement. And this is a major stumbling block to concentrated international action against counterfeit production.

Maybe I'm wrong and people can correct me, but I doubt Brazil and India will work within the current framework. It may be time to think of a separate framework convention within WHO for going after pharmaceutical crimes. This might benefit Indian government enforcement since it might provide officials greater political cover to go after poor producers (those not up to GMP).

Recall these overlapping sets. If one believes data from China and India most of the problem is non-counterfeit substandard products.

I don't know if they're correct, but in the data we generated in our study over half the drugs we found were substandard were not obviously violating a trademark or other labeling infraction.

At the same time--trademark enforcement is still vitally important, it is often the first, often the only, means of finding out about poor quality medicines in the market. And here it will come down to Indian businesses wanting greater enforcement of intellectual PR. On this topic I am optimistic--the various partnerships between western and Indian companies are vital in this regard. And we need more of them.

Roger Bate is the Legatum Fellow in Global Prosperity at AEI.

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