Stemming the tide of counterfeit medicines

Global trade in counterfeit medicines kills on a grand scale. Manufacturing Chemist investigates some of the worst affected areas and efforts to counter this illegal trade

If there is one crime condemned worldwide it is the sale and smuggling of counterfeit medicines. Sometimes close copies and sometimes dangerous substances, this crime kills on a grand scale.

Counting the number of its victims accurately is difficult because of the subversive nature of the trade, but some think-tanks have tried. The US-based International Policy Network has claimed fake tuberculosis (TB) and malaria drugs alone kill 700,000 people annually worldwide. This was based on World Health Organisation (WHO) analysis claiming that at least 200,000 malaria deaths per year would be prevented if patients were not using counterfeit medicines. It added this to peer-reviewed academic studies suggesting 10% of TB medicine is fake – and with 9 million TB victims worldwide and a 50% chance of death if the disease is not treated properly, counterfeit TB meds kill another 450,000 people anually.

The manufacture and trade in fake pharmaceuticals is almost impossible to measure precisely. In future, the extent of the problem may become clearer through a new WHO initiative. At a meeting in November 2012, 200 member states agreed to develop data collecting systems on substandard and falsified medicines. A WHO capacity-building project is also testing and developing surveillance tools for low- and middle-income countries.

The goal of having clear data adhering to common collection standards is to help orientate drug quality programmes. The IoM report noted: ‘If the data indicate that substandard medicines are the main problem in one part of the world, then better regulation of manufacturers can do much to improve the problem.

‘Similarly, if it becomes clear that a country has a problem with diverted medicines in commerce, then distribution chain improvements would enhance the national drug safety programme.’

The Pharmaceutical Security Institute (PSI) conducted an open source review of fake medicine seizures in 2011. In India, it highlighted the seizure of 250,000 counterfeit dosage units of Coscold cough tablets; and 388,000 ‘spurious’ antibiotics. While the Indian government and pharma companies are battling the menace of fake drugs, the country’s vast population and a deeply ingrained disregard within the public and private sector to respect legally mandated procedures pose serious challenges.

A study conducted in 2009 by the Central Drugs Standard Control Organisation of India found only 0.3% of drugs sold in India to be counterfeit. However, according to Bejon Misra, founder of the Partnership for Safe Medicines India, the real figure is much higher: ‘The study was confined to retail outlets while most of the counterfeit medicines are distributed through government-run hospitals or by small chemist in remote areas.’

According to T S Jaishankar, chairman of the Confederation of Indian Pharma-ceutical Industry (SSI), counterfeit drug makers in India use makeshift units and target a few, popular, high-value drugs that have packaging that is easy to copy. However, according to Misra, the drugs of big multinationals are less likely to be faked: ‘These companies maintain a very effective private intelligence service to track duplicates of their own drugs.’

Hardly anyone asks for the receipts in India, so fake drugs get passed off as originals

Both Misra and Jaishankar said that while Indian laws are adequate, their implementation is not. According to Jaishankar, many Indian chemists store a mix of originals and duplicate drugs.

‘Hardly anyone asks for the receipts in India, so fake drugs get passed off as originals,’ he said. Furthermore, it is a common practice among Indian chemists to sell loose tablets after cutting a strip. ‘This way, the whole system goes out of control,’ said Jaishankar.

Pharmaceutical exports from India are largely considered free from fakes, at least compared with the situation in China. ‘They are protected with unique barcodes to assure their authenticity,’ said Nakul Pasricha, VP of Operations at PharmaSecure, a US-based company that provides drug authentication services. The awareness of the problem is growing rapidly. ‘There are several hundred consumer interactions with our system every day,’ said Pasricha.

Of course China is accused of being the largest source of counterfeit medicines, with many cargoes sent abroad, especially to sub-Saharan Africa. In a long list of transgressions, the PSI report noted the seizure of 6.9 million counterfeit doses of genito-urinary medicine and 1,440 arrests associated with fake medicines worth around US$314m.

Chinese consumers suffer as well, despite annual Chinese government crackdowns on counterfeit medicines. In 2012, Chinese law enforcement reported 14,000 seizures of faked drugs within mainland China, more than double 2011’s figure of 6,500. The retail value of the medicines seized in 2012 exceeded CNY16bn ($2.52bn), according to China’s State Food and Drug Administration (SFDA). In a statement, the SFDA said criminals have become ‘more organised, discreet and tech-savvy’ by heavily using business-to-consumer sites to reach victims.

China’s strong e-commerce sector has been a boon for the counterfeiters. For example, a quick online search for Pfizer’s heavily counterfeited Viagra reveals many China-based B2C sites. To fight against fake Viagra, Pfizer China has launched a smartphone app, which allows customers to scan the barcode and verify if the drug they bought is authentic.

We see an increasing amount of highly recognised brand drugs for chronic diseases

‘Most of the fake drugs we caught are for sexual performance enhancement. But we also see an increasing amount of highly recognised brand drugs for chronic diseases,’ said a police source for Quzhou, Zhejiang province, south of Shanghai, referring to fakes of Iressa, AstraZeneca’s cancer treatment, and Bayer’s Glucobay for diabetes. He added medical professionals are usually involved in manufacturing and marketing such fake high-end drugs. Quzhou police participated in a national crackdown against fake drugs in August last year led by China’s ministry of public security (MPS). According to an MPS spokesman, these fake drugs are made from anything from harmless flour to potentially harmful (if taken wrongly) active ingredients glyburide and metformin.

Cross-border trade is also rising, according to the SFDA. In June 2012, policemen in Tianjin caught traders selling fake cancer drugs from India and Hong Kong online to Chinese patients. According to China Customs, imported fake drugs are mainly from South Korea, India and the US, while China-made counterfeit drugs usually go to the UK, US, Australia and Japan.

Probably the most embarrassing cross-border fake drug scandal for the Chinese government is the counterfeit malaria drug exported to Africa, which has provoked international criticism. According to the US National Institutes of Health, about 42% of antimalaria drugs sold in southeast Asia and sub-Saharan Africa are fake or poor quality, and many are made in China. In December, China’s ministry of foreign affairs denied China is the major supply of fake anti-malaria drugs in Africa, saying it is ‘nonsense’.

And it would seem all sub-Saharan African countries are targeted by these illicit medicine exporters – indeed a World Customs Organisation crackdown on illicit medicines in 16 African countries last October netted 82 million doses of illegal drugs. A Gallup poll of countries in the region released in 2011 showed a widespread appreciation by consumers that they could be taken for a ride when buying medicines. Between 25% (South Africa) and 91% (Cameroon) said they were aware of the presence of fake medicines on their respective markets, driving an arguably dangerous renaissance in traditional healing.

Western companies and governments are not the only parties interested in halting the spread of counterfeit medicine into African markets; local pharmaceutical producers in Africa’s own burgeoning industry are also trying to stop them. ‘They are fake and illegal,’ said Tsungi Moyo, spokesperson for the Federation of African Pharmaceutical Manufacturer Associations. ‘There are no benefits.’

A World Customs Organisation crackdown on illicit medicines in 16 African countries last October netted 82 million doses of illegal drugs

A good example of a problem market is Cameroon. Douala, with its airport and seaport, is the centre of Cameroon’s illicit drug trade. Many drugs imported into the country through these portals come from India and China. Minister of Health Andre Mama Fouda ordered that the painkiller Tramol and the drug Cotecxin be withdrawn from the country’s market because versions of these drugs containing no active ingredients had flooded the market. According to Dr Joseph Bekoti, from the health department for Cameroon’s Littoral region, whose capital is Douala, one in four drugs in circulation across Cameroon is counterfeit. As former head of the Littoral region’s illicit medicine unit, he insists the problem is complex, and almost impossible to assess with precision. However, his statistics show that, last year in Douala, Central African Francs (XAF)700m ($1.39m) worth of illicit drugs were destroyed.

Vice president of the Pharmaceutical Society of Cameroon, Dr Prosper Hiag, estimated that the legitimate pharma sector in Cameroon loses between 30% and 40% of its sales to the counterfeit trade. To make matters worse, there is no specific legislation outlawing the trade, only general criminal laws, which are hard to enforce in the sophisticated world of counterfeit medicine sales. Regional governments have established committees to assess the problem, but they lack resources.

National government sponsored insurance for everyone is what is needed to make inroads in the fight against this cankerworm

Poverty, of course, is a key driver of the trade. A drug treating pregnant women for Rhesus negative blood type related health conditions sells for XAF25,000 ($49.80) in the pharmacy. On the black market, however, the price is XAF5,000 ($9.98). The small clinics that sell these counterfeit drugs convince women they have the same efficacy as legitimate drugs, which is hard to check, especially as even legitimate drugs are often smuggled into Cameroon through theft and illegal importation.

Dr Hiag thinks the government should do more than educate consumers about the risks: ‘National government sponsored insurance for everyone is what is needed to make inroads in the fight against this cankerworm.’

Regionally, the Federation of African Pharmaceutical Manufacturers Associations (FAPMA) was formed earlier this year to help combat the influx of counterfeit medicine, uniting pharmaceutical associations from across the continent. And Ms Moyo stressed at FAPMA’s launch that fighting fakes had economic benefits too, helping local medicine manufacturers survive: ‘Self-sufficiency in healthcare is important for economic growth,’ she said.

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