Posted by Roger Bate
Rather than address directly the problems within its industry, India’s Commerce Department and drug industry affiliate groups are claiming “vested interests” are at work to unfairly undermine its reputation
. “India is showcasing its best pharmaceutical manufacturing facilities to regulators from emerging economies to counter adverse publicity the country's drug industry has endured in recent times”, reported the Economic Times.
Health ministers and officials from countries including Kenya, Ghana, South Africa, Vietnam, Egypt and the Philippines were hosted by India at the end of 2013. "The idea behind this programme is to promote Indian pharmaceutical exports, apart from improving confidence among the global community that India is a trusted source for quality generics at affordable prices," said PV Appaji, director-general of the Pharmaceuticals Export Promotion Council. "There has been propaganda by vested interests among the global community, particularly trying to project India as a country with poor regulatory standards," said Appaji, echoing remarks by Commerce Department staff.
In any commercial sector there are always vested interests which can benefit from a competitors misfortune, and hence even promote narratives about that misfortune. In that sense India is correct that western industry is probably making the most of India’s problems (although I have seen no public pronouncements to this effect), but that doesn’t mean the problems don’t exist, or even that western industry is misleading anyone about India’s problems.
As the author of the Economic Times piece wrote wrote, “The commerce ministry is of the view that "vested interests" are deliberately tarnishing the Indian drug industry and that some countries are not adequately aware of the stringent regulatory standards being enforced in the domestic market.”
But as we point out in our working paper with Ranbaxy whistleblower Dinesh Thakur
, the idea that India enforces stringent regulatory standards is quite simply laughable.
Until India acknowledges its problems, solutions will not only not be found, but they won’t even be looked for.
Today, we published our fourth SearchingForSafety Working Paper
focused on India’s paradox – it is the largest drug exporter and the most isolationist drug industry. As we argue, India’s main problem now is that nationalism has replaced health protection as the guiding principle of drug regulation.
Regulatory collaboration is increasing at the global level. In the past two years the Brazilians and Chinese (two nations which like India have fought intellectual property battles with the west) are collaborating with western regulators and working out how to improve drug quality. Yet as more players come to the table to formulate policy for access to quality, safe and effective medicines, India continues to remain outside the fold.
A co-author on the paper is Dinesh Thakur who draws on his experience bringing to light the quality control failures at Ranbaxy, India’s most famous drug producer. The result of Thakur’s whistleblowing was a historic criminal case with Ranbaxy found guilty of seven felony counts, paying a $500 million fine. The impact on patients of Ranbaxy’s mendacity is simply unknown. Thakur joined me for a lively panel discussion on the subject at the American Enterprise Institute
We also heard from Dr. Andreas Seiter, the World Bank’s leading pharmaceutical expert who acknowledge high levels of corruption in pharmaceutical production in emerging markets like India, and Dr. Harry Lever, a renowned cardiologist who discussed having to switch patients from generics back to brand medications due to poor responses.
You can watch a video of the full event here
Posted by Roger Bate
When it comes to purchasing medicines from certain Indian generics companies, buyer beware. As my colleague Dinesh Thakur and I lay out in a new op-ed
in the International Business Times, Americans are ingesting a large—$4.2 billion last year—and increasing volume of generic medicines imported from India. But the government of India has proven complacent at ensuring the quality of those medicines, including commissioning but then ignoring reports on the regulatory failings of the country’s pharmaceutical industry.
Earlier this year, one of India’s largest pharmaceutical companies, Ranbaxy, pleaded guilty
to seven criminal charges, including falsifying clinical data and distributing adulterated medicines to the United States. As an editorial
last week in the leading Indian newspaper The Hindu stated, “Until a deeper, institutional change takes place to break the nexus between drug companies and India’s regulatory regime—a change that incorporates everything from surprise checks on manufacturing facilities to greater transparency in, and policing of, drug approvals processes and clinical trials—there is a strong likelihood that Indian consumers of drugs made by these companies have poison coursing through their veins.”
Read the full op-ed here
Posted by Roger Bate
The Wall Street Journal released details this week
of an investigation into large quantities of stolen—aka “diverted”—malaria medicines that the US government had donated to African countries through the President’s Malaria Initiative.
According to the article, the President’s Malaria Initiative has had a huge hand in reducing Africa’s malaria rate by a third between 2000 and 2010.
From the article by Benoît Faucon, Nicholas Bariyo and Jeanne Whalen:But the effort has been partly hijacked by organized networks that steal large quantities of donated malaria drugs and ship them from East to West Africa, where they end up for sale at street markets, according to people familiar with the U.S. investigation. … Angola's health minister, Jose Van-Dunem, says that "maybe 15%" of donated malaria drugs are stolen annually. According to a person familiar with the U.S. investigation, more than 20% of donor-funded Coartem in Africa may be diverted each year—with a street value of about $60 million.
As the journalists correctly point out, in addition to the criminal ramifications, the theft of such large quantities of medicines could have severe negative public health consequences. If medicines aren’t stored properly, including while being trafficked across the continent in hot trucks, their quality could degrade. Not only could that leave people to die as a consequence of ingesting substandard Coartem—it could facilitate the emergence of resistance to one of the most important malaria drugs.
Hopefully the investigation is successful and leads to arrests and an end to the activities of the organized criminals involved. The theft of malaria medicines has been a challenge for several years, as my colleagues and I documented in 2010 when we published a study
showing that 6.5 percent (of 894 samples) of anti-malaria medicines purchased from markets in 10 African cities had previously been stolen and diverted to the informal market.
The Global Fund to Fight AIDS, Tuberculosis and Malaria—the world’s leading source of international financing for malaria control efforts—held its most recent board meeting on November 7-8. At the meeting, the Global Fund’s inspector general reported
that it is working with Interpol, the inspector generals of USAID and UNDP, and other agencies to ramp up its efforts against the infiltration of falsified medicines as well as the theft of medicines. They reported finding “a number of” falsified versions of artimisinin-based combination therapy (ACT) medicines used to treat malaria in West Africa, including samples with little or no active ingredient. Such collaborative efforts between the world’s leading public health agencies and financers is necessary to curb both large-scale theft and falsification.
Read the WSJ’s story here
Read the Global Fund Inspector General’s Progress Report here
This post is by Roger Bate, Adjunct Scholar at the American Enterprise Institute.
Our third SearchingForSafety Working Paper is published today, analyzing surveys of attitudes on medicine quality among pharmacists and their customers in Delhi. Initially conducted in 2008, we repeated a set of surveys this year and found some interesting differences.
Notably, fewer of the pharmacy staff were willing to speak to our surveyors and insisted we speak with the pharmacist himself. Pharmacists also appeared far more knowledgeable about the terms; reporting that they had not been offered “spurious” products. They also reported being comfortable providing “cheap medicines”, and didn't care, as one put it, “if the medicines were deceptively similar to a well known [trademarked western] product”.
It doesn't appear that Indian pharmacists are directly aware of the international fights on trademarks, but rather believe that “western interests” are out to get them. Indian pharmacists opinions appear to have become both more nationalistic and certain since 2008, and could be summed up this way – our products are safe, only westerners claim we sell poor quality medicines, and they do that to damage our industry because we sell safe, cheap medicines that outcompete them.
Surveys were also conducted of customers leaving pharmacies, who appeared to have purchased medicines, in an effort to understand their knowledge about medicine problems in India. We suspected that Indian consumers would underestimate the dangers of low quality medicines.
We found that the vast majority of customers had even stronger views about counterfeit medicines than pharmacists. When asked whether they were concerned they might have just bought counterfeit or substandard medicines, over 90% said they were not. Most of them thought such medicines would be cheaper and probably just as effective, especially the counterfeit medicines, since many had similar opinions to one customer who stated that “brands just mean higher prices, and I don’t want to give my money to corporates [big business]”.
You can read the full paper here.
This blog comes from Lorraine Mooney, Contributor to SearchingForSafety.net.
Having worked on the fake medicines issue for a number of years, it came as a surprise that the issue is reaching the mainstream, which is what happened at London’s Chatham House recently when the issue of poor quality medicines was presented to an audience of international affairs analysts.
Panel member Professor McKee gave an overview of ‘falsified’ medicines – suggesting the solution was to strengthen national regulation through advice and support, improve intelligence and enforcement of criminal activities, especially organised crime – but he fears that money will not be found to support public health.
Professor KcKee is right to emphasise that this is a problem of under-capacity in developing countries, although there is a strong role to be played by international co-operation on intelligence and enforcement, which was discussed by other panel members. But his pessimism may be misplaced because those worst affected are taking action, witness the agreement signed in Washington DC at the end of October
between regulators and business to deploy Minilabs to Ghana and train staff to use them to detect medicines of poor quality.
Dr Charles Clift, who convened the meeting, suggested a discussion of possible action against legal, but deliberately substandard products (where licensed producers cut corners to reduce costs while disregarding safety standards), which may also be distributed on a far greater scale, and attract no suspicion if they come through international aid channels.
Sadly, no panel member chose to take up this thread even though what evidence we do have suggests that substandard but legal meds are a far greater risk to public health than fakes made by criminals.
Representing WHO and Novartis respectively, Michael Deats and Andrew Jackson held similar stances – they want information about the nature of the counterfeiting business: what demand is it feeding? What are the logistics – where and how are the products moved around?
In fact, both are part of international cooperation with the likes of INTERPOL, WCO, WIPO which have been quietly doing sterling work in building partnerships, running training and technical programs and orchestrating large-scale operations to break up international criminal networks involved in trafficking fake medicines.
There are of course, advantages in raising awareness – not least in that it increases the chance of funding – but it can be a distraction and the old hands like Deats and Jackson were visibly weary at having to rehearse long-familiar arguments to a new audience in the face of their various, tangential and often misconceived views.
Ah well, someone’s got to do it.
This post is by Roger Bate, Adjunct Scholar at the American Enterprise Institute.
India’s medicines regulator (DCGI) says it wants to assess the quality of medicines in India, following complaints from the west.
He says this will cost about $40-50m Rupees, or less than $1 million dollars. This would be a welcome assessment, and it appears he wants to involve external experts such as Interpol. But as I have pointed out before
, if the sampling method chosen by the Indian regulator is flawed then the results will be useless. Taking samples from NGOs to test could introduce biases, some known (depending on the aims of the NGO) some not. If the Indian regulator wants to improve western acceptance of Indian medicine quality, then he should involve some foreign experts who have actually overseen samplings to minimize bias.
If he doesn’t’ this will simply be a repeat of the 2008-10 CDSCO exercise, the results of which are unreliable.
This post comes to us from Dr. Paul Orhii, Director General of Nigeria's National Agency for Food and Drug Administration and Control, and Roger Bate, Adjunct Scholar at the American Enterprise Institute.
A decade ago, half of Nigeria’s medicines were fake or substandard. Today, it’s less than 15 percent, based on a new study I’ve published today
with Paul Orhii, Head of NAFDAC (Nigeria’s health regulator), and others.
The Nigerian government has accomplished this by seizing shipments of fake medicines
, making arrests
, and deploying hand-held technology to help find bad drugs before
they hit the marketplace.
TruScan, a handheld raman spectrometer that can determine, with considerable accuracy, whether a sample of medicine has the appropriate chemical makeup or not. NAFDAC agents are deploying the tool in the field; when samples fail the TruScan test, they’re collected and followed up with testing in the lab.
Our study comparing TruScan quality testing results with those from the lab is the largest field study of its kind to date. And the results demonstrate that the TruScan device is effective at identifying fake and substandard medicines, without falsely identifying good ones.
Nigeria’s progress is inspiring. Still, as we argue in an op-ed on FoxNews.com today
, there is only so much that Nigeria or any country can do on its own, or even through regional cooperation. Winning the global war on bad medicine will require an international treaty that sets clear standards for drug quality – and enforces severe penalties for offenders.
We’ve had a global treaty against counterfeit bank notes since 1929. Surely patients deserve the same protections in the 21st century. Until then, we may continue to win battles against purveyors of fake and substandard medicines, armed with new technologies and strong political leadership. But we will never win the war on bad medicine.
This post comes to us from Roger Bate, Adjunct Scholar at the American Enterprise Institute.
Shanghai has just opened a free trade zone to much fanfare, loosening some controls on investments in China. But like so many Chinese developments it is a double-edged sword. In this article published today in RealClearPolicy
, I discuss the trade advantages and health risks that come from a free-for-all in the market for bulk chemicals – many of which come from China, but whose exact provenance is not known. These chemicals go into medicines and can make them very cheap, but with poor quality control, such medicines can prove lethal instead of life-saving.
China is home to some of the cheapest products on the planet, but the country also produces many fake ones. My colleague Nick Slepko interviewed numerous folks in China and Hong Kong about the fake trade in China, and here he and I discuss the problems related to baby milk formula
. Over the past decade there have been numerous instances of contaminated, adulterated and outright fake milk formula being sold across China. This resulted in at least six dead babies and hundreds of thousands of sick babies.
It also led to a political backlash, where the Chinese response was to ban worried parents from importing milk formula from overseas. A $50,000 fine and two years in jail awaited parents who just wanted to make sure their child wasn’t contaminated with fake milk.
Hopefully the Shanghai free trade zone will have better controls over product safety than the one in Shenzhen, where much of the fake milk formula is allegedly made.
This post comes to us from Amir Attaran, Associate Professor in the Faculties of Law and Medicine at the University of Ottawa. He also holds the Canada Research Chair in Law, Population Health and Global Development Policy.
Of all the continents, Africa is arguably the worst afflicted by substandard and fake medicines. But African health professionals seem surprised to learn of that fact. This is the unexpected conclusion of a health professionals’ workshop and lecture that I gave in Cape Town at the annual meeting of the Public Health Association of South Africa. Simply put, I scared the wits out of many of my African colleagues, which is hardly what I expected.
To those of us who research poor quality medicines—or to be more precise intentionally “falsified” and unintentionally “substandard” medicines—it often goes without saying that the most concerning studies of medicine quality are from Africa. Although African studies are still too few in number, those that exist almost always point to grimmer results than studies conducted elsewhere. Africa is ground zero in the deadly and dangerous impact of falsified and substandard medicines today.
For example, my colleague Roger Bate with his team recently published results on the most important tuberculosis medicines, isoniazid and rifampicin, and found that the African failure rate was higher than in India or various middle-income countries. Fully 16.6% of these medicines—or one in six—of these medicines is dangerously substandard or falsified in Africa.
If Roger’s results roughly hold across the continent, and there is no reason to believe that they do not, then faulty medicines are possibly the leading cause of multidrug resistant (MDR) and extensively drug resistant (XDR) tuberculosis—which is fatal, becoming more prevalent, and frighteningly near incurable. In India it is well understood that bad quality medicines have contributed to the subcontinent’s resistance problem, including at the severest and invariably fatal level, totally drug-resistant tuberculosis. Africa imports a great deal of Indian-made medicines, so could this be an overlooked explanation for resistance in Africa too?
To my surprise, this question hardly has been posed among African public health experts. While polls show that a majority (sometimes a large one) of Africans are aware of fake medicines where they live, this sentiment seems less common among the African doctors who I addressed, and who of course wish to believe that the medicines they offer patients are helping them. After the workshop, many health professionals from South Africa, Nigeria, Malawi and elsewhere came up to me and said things like, “I never knew.”
So having alerted my African colleagues to this danger, will there now be more rigorous research of medicine quality in Africa? I hope so: Africans’ lives depend on it. Certainly the problem is now a high priority for Public Health Association of South Africa and World Federation of Public Health Associations, who have prepared a communiqué on the workshop. Expect that document to call for more research, and to endorse an idea that we have been advocating for consistently: a global treaty to establish standards of medicine quality, to build drug regulatory capacity in Africa and other poor parts of the world, and to apprehend and punish the organized criminals who so cruelly—and fatally—debase the quality of medicines on which we all depend.