FROM MAGAZINE: Industry stakeholders collaborate to fight illegal pharma supply chains

Africa is the only continent where counterfeit medicines cause more deaths than non-communicable diseases such as cancer, diabetes, cardio-vascular diseases and respiratory diseases. Every year, more than 100,000 Africans lose their lives as they fall prey to counterfeit anti-malarials. The onus lies in the hands of logistical service providers, pharmaceutical companies and regulatory bodies to fight illegal supply chains of spurious drugs. Surya Kannoth reports.

Imitation may be the sincerest form of flattery but when it comes to spurious pharmaceuticals, it is far from flattery and could pose a serious threat to life.

Counterfeiting medicines is one of the world’s largest and fastest growing industries. Recent studies suggest that one in 10 drugs around the world is counterfeit, and this statistic can reach seven in 10 in developing countries.

As for Africa, it is the only continent where counterfeit medicines cause more deaths than non-communicable diseases such as cancer, diabetes, cardio-vascular diseases and respiratory diseases. Every year, more than 100,000 Africans lose their lives as they fall prey to counterfeit anti-malarials.

One of the major challenge associated with a fake drug is that a layman cannot differentiate between genuine and counterfeit drug without the help of a special instrument or device. The packaging, shape and size of counterfeit drugs are made identical to that of an authentic drug by the counterfeiters. However, these fake drugs might not contain any active ingredients at all; they might contain the correct ingredients but at the wrong dose; or they could contain highly toxic ingredients. While ingesting a fake aspirin without any active ingredient most likely won’t have any major negative health effects, counterfeit medicines used to treat patients with life-threatening conditions like HIV/AIDS and malaria have devastating consequences.

The demand for counterfeit drugs is highest in impoverished, underdeveloped countries where a majority of the populace cannot afford or obtain medicines from legal sources. Weak, inconsistent laws and regulations, combined with a lack of visibility in the supply chain, allow illicit distributors to introduce counterfeit medicines, which often end up being sold in pharmacies or administered in hospitals

Pfizer, in one of its report, points out, “…growing involvement in the drug supply chain of under-regulated wholesalers and re-packagers, the proliferation of Internet pharmacies, advancements in technology that make it easier for criminals to make counterfeit drugs, and the increased importation of medicines.”

Increasing technologies to combat counterfeits

Over the past decade, with increased publicity about the devastation caused by diseases like AIDS and malaria and more recently about the quality of drugs distributed in Africa, the situation has begun to improve. Some brand-name and generic drug companies have increased production of essential drugs, making products available to aid programs at cost or donating them for free, providing the imprimatur — staked on their reputation — of a high-quality product. Some pharma companies like Bristol-Myers Squibb or Merck are operating complete treatment programs, training staff and building clinics.

As counterfeits grow, so have technologies come up to detect the legitimacy of drugs. From authentication technologies to Track & Trace to RFIDs, pharmaceutical companies are trying to find solutions to bring an end to this menace.Apart from these technologies, many other significant measures have been taken by pharmaceutical companies and government authorities to tackle this growing problem.

Authentication Technologies (the technologies providing overt and covert security features) and Track & Trace Technologies (the technologies facilitating visibility of products throughout the supply chain) govern the anti-counterfeit supply chain. Specifically in the authentication segment, technologies providing covert security features are very popular and occupy a major share in of the overall authentication market. These technologies are very difficult to mimic and require special instruments / devices for verification of drugs by the manufacturers.

Managing supply chain, especially in case of pharmaceutical industry, remains a big challenge. Given the complexity of the pharmaceutical supply chain, it makes an ideal target for counterfeiters. Several countries across the globe have passed legislations, making it mandatory to implement serialisation by the manufacturers. Serialisation is being thought as a one stop solution to prevent counterfeiting in the pharmaceutical industry by securing the supply chain.

The field has attracted several companies which have developed many technologies with an aim to prevent counterfeiting in the pharma industry. The overall interest continues to rise as is evident from the number of counterfeit incidents and various laws and legislations being passed throughout the world. Small companies that have developedanti-counterfeiting technologies are likely to play a very active role in the near future.

Sproxilis a technology firm, which has set up Africa’s first national, mobile-based anti-counterfeit service in Nigeria, and has already has sold more than five million anti-counterfeit labels.

The service requires participating drugs companies to apply for scratch-panel stickers that can be attached to their packets of drugs. Customers scratch off the panel to reveal a code which they text to Sproxil. The company checks the code against its database of genuine drugs and texts back a confirmation of authenticity.

Buyers can also scan the barcode or simply ring a call centre which works 24 hours a day, seven days a week to verify that the drugs are genuine. And Sproxil has introduced incentives for consumers to use the service, such as mobile phone air time rewards. In Africa, the scheme operates in Kenya, Ghana, Nigeria, South Africa, Tanzania, and Mali.

More than 70 drugs companies have signed up to the service, including multinationals such as GlaxoSmitKline and Novartis, according to the technology firm, and about 28 million verifications have taken place globally since the launch of the scheme.

As a part of the MPA technology, Sproxil gathers important consumer data that brand owners can leverage to optimize their marketing program, monitor for counterfeiting hot spots, or gain a better understanding of consumer purchasing habits. Sproxil’s MPA solution is compatible with any tangible item, and is widely used by top ten global pharmaceutical companies as well as top ten Indian pharmaceutical companies.

In addition to Sproxil’s flagship MPA, Sproxil offers a comprehensive track and trace solution for the supply chain called Cascading Authentication, as well as advisory services to help brand owners streamline business processes, enhance product’s reputation, and increase profits. Sproxil’s flexible, mobile-based solution can also supplement communication efforts and marketing campaigns. The solution can be used to deploy consumer loyalty campaigns, sweepstakes, and consumer engagement programs that have proved to both encourage consumer use and increase sales.

Another entrepreneur Bright Simons has also set up a similar ‘verify-by-mobile’ system called mPedigree Network nearly 10 years ago. Printed barcodes and scratch-off stickers, developed in partnership with US tech giant Hewlett-Packard, help consumers check authenticity against a central database.

The US Pharmacopeial Convention (USP) has been working to address this menace across the world, including in Africa. Three years ago, the USP opened the Center for Pharmaceutical Advancement and Training (CePAT) in Accra, Ghana, to improve pharmaceutical quality in Ghana and across Africa. The centre serves as a platform to train African professionals and build capacity for domestic and sustainable drug quality systems. Since 2013, CePAT has helped train 190 professionals from 32 African countries, writes Ronald Piervincenzi, chief executive officer of the United States Pharmacopeial Convention, in an opinion piece for SciDev.

Apart from training the professionals, CePAT is also involved in drug screening. In 2013, USP — through its Promoting the Quality of Medicines Program and in collaboration with Ghana Food and Drugs Authority (GFDA) — discovered serious issues with the quality of oxytocin, a drug used to treat excessive blood loss within 24 hours of birth. In fact, data showed that 90 percent of the oxytocin tested in Ghana was substandard.

Based on these findings, the Ghana FDA met with the ministry of health procurement unit to impress upon them the need to have all government-procured products vetted and registered by the FDA before they are imported into the country. The FDA also issued nation-wide press release informing the public about the poor quality batches and recalled them from the market.

In February 2016, the USP and CePAT opened a brand new lab to train pharmaceutical and regulatory professionals in microbiology testing. This new laboratory will hopefully help more pharmaceutical professionals across Africa learn to detect medicines that have been contaminated by microorganisms, and will be able to keep more people in their community safe from poor quality medicines arising from contaminated products.

In October 2016, Merck Germany, a leading science and technology company, donated two Minilabs to the Ivory Coast (West Africa) thus acknowledging its support to fight counterfeit medicines. The handing over of the Minilabs took place during the opening of Merck’s new office in the capital of Abidjan.

The Minilab is a mobile mini-laboratory that helps in the detection of counterfeit medicines with simple but reliable test methods for rapid drug quality verification. Almost 800 Minilabs have been supplied to health facilities worldwide so far. Due to the donation of Merck, the Minilab is now also available in Côte d’Ivoire. The Minilab development and project work is run by the Global Pharma Health (GPHF), Merck’s charity arm in Frankfurt.

According to The Access to Medicines Index 2016, published on November 14, the GPHF-MinilabTM is one of the exemplary international healthcare projects. Through its fundings, Merck enables the projects of the GPHF for a long time. Meanwhile more than 750 mobile GPHF-Minilabs to detect counterfeit drugs are in operation all over the world. Further projects by Merck rated in the index are the donation of medicines to fight bilharziosis and a national program to control malaria in Namibia. The Access to Medicine Index is published every two years by the Access to Medicine Foundation, an international not-for-profit organisation dedicated to improving access to medicine for people in need. The organisation receives financial support from donors such as the Bill & Melinda Gates Foundation and the Dutch Ministry of Foreign Affairs.

While watchdogs have been finding it challenging to trace the network of counterfeit trade and make a stop to the business affecting people's health, countries and global agencies like Interpol are working together to curb the floatation of fake drugs. Logistic companies also play a major role in the safe and secured delivery of pharmaceutical products to countries across the globe and an effective collaborated effort between logistics solution providers, drug manufacturers, and regulatory bodies can be instrumental in bringing down the supply of counterfeit drugs in the market. Global logistics company DHLacknowledges that while it is difficult to estimate the loss of revenue for pharmaceutical companies, counterfeit or falsified drugs can damage public trust, resulting in a decrease in investment in the pharmaceutical industry.