By 2020, track and trace regulation is expected to cover 80 per cent of the global drug supply. More and more countries are introducing laws that will have an impact on companies producing, distributing, or dispensing pharmaceuticals across the globe.
US FDA has already started first phase of Drug Supply Chain Security Act (DSCSA). European Union sets February 2019 for serialized authentication of pharma products. Emerging markets like Australia, Egypt, Russia, Saudi Arabia and Taiwan are coming up with track and trace regulation.
In Australia a new regulation for bar code identification for all pharma products was passed last year. The country has bar coding and serialization law for blood components and fresh blood products. In September 2016, new regulations were published, requiring enhanced labelling (but not serialization) for all medicines for the Australian market. The law will be enforced by September 2020.
In Egypt the serialization and track and trace reporting requirement includes bar coding, serialization, and government reporting of information on all pharmaceutical products and transactions to a central repository. The country has evinced an interest to follow Turkey’s model for a traceability and compliance reporting system. The implementation of track and trace law in Egypt spans over 10 months starting from September 1, 2017 to June 1, 2018.
In Russia pharma serialization and tracing pilot guidelines approved by Minister of Health in March 2017 is the latest stage in a pharmaceutical serialization initiative that could become mandatory by the end of 2018 – although this is not yet confirmed. The system involves applying unique serialized identification codes to drug products, and capturing and reporting to a central repository key events associated with the those products as they move through the supply chain. It is due to run from February 1 to December 31 this year, with a final report expected by February 1 2018.
In Saudi Arabia regulators have completed phase 1 which requires bar coding on products. Enhanced serialization has been implemented in the second phase beginning March 2017. The requirements are following GS1 standards for both the bar code and data. Product scope for the regulations includes all pharmaceutical products, including human and veterinary. The original law has always stated that there will be forthcoming requirements for reporting information about the products to some central repository.
The country is looking at Turkey as a potential model for a traceability and compliance reporting system with enhanced serialization requirements including navigation. Pharmaceutical companies need to replace linear bar codes with GS1 Data Matrix bar codes which comprise of a unique product identifier, batch number, expiry date and serial number.
As the Pharmaceutical Affairs Act, Taiwan Food and Drug Administration (TFDA) has implemented track and trace system for three priority categories -- Plasma-derived medicinal products, Vaccine and Botulinum toxin from July 1st, 2017. The product license holders, wholesalers and retailers are required to submit the tracking and tracing information electronically before 10th of every month.
The degree of risk, and quality, efficacy and safety of medicines are taken into account to prioritize these three categories of medicines to be implemented with the prescription drug track and trace system.
Serialization of pharmaceutical products and reporting to a national, centralized hub will be mandatory in Brazil as per law 13.410. On December 28, 2016, after lengthy discussions and a temporary suspension of already active legislation related to pharmaceutical serialization, the Brazilian President signed the law 13.410, thus amending the ones dating back to 2009 and 2013.
Serialization at both the unit and case (transport packing container) levels will be mandatory in Brazil for all pharmaceutical products. Cases will have to include information as to which units they contain. Tracking will be required at each level of the supply chain, including certain events beyond entry/exit at manufacturer/importer, wholesaler, distributor, and pharmacy levels. Pharmaceutical products manufactured outside of Brazil may be serialized upon entering the Brazilian market.
The 2D bar code or Datamatrix must be encoded with ANVISA registration number, Serial number, Lot number and Expiry date. Brazilian coding standards are similar to GS1 standards but not exactly the same. Batch number and, obviously, a GTIN follows the same format required by GS1. However, there are differences regarding the (numerical) serial number (13, not 20 digits), the production and expiration date (MM/AAAA format). The numerical ANVISA registration number contains 13 digits.
Each player within the drug supply chain will have to report when a product passes through their facility. This has previously been the case, however, until now, pharmacies, distributors and other trading partners fed supply chain information back to the Marketing authorization Holder (MAH). In the future, information will be reported to a centralized reporting authority established by ANVISA. This centralized system will store and better analyse all information related to pharmaceutical products covered by the new law.
From the signature of Law 13.410, ANVISA has four months to define the scope of the pharmaceutical products covered under the law and specify detailed instructions. Pharmaceutical companies and CMOs then have one year to put prototype testing of three batches in place. Results will need to be communicated to ANVISA. ANVISA then has 8 months to analyse industry feedback and serialization prototypes. Once reports are validated, players in the pharmaceutical industry will have three additional years to fully implement serialization which will result in a December 2021 deadline. By 2022, all pharmaceutical products will have to be serialized and traced throughout the supply chain.
According to the public notice issued by the Directorate General of Foreign Trade dated 10.01.2011, exported pharmaceutical products should have track & trace capability using the bar code technology as per GSI global standards. Requirements are that 2D bar code at the primary level; 1D or 2D on the secondary level and 1D at the tertiary level packaging encoding the GTIN code, batch number, expiration date and serial number of respective packaging. However this system does not ensure the absence of counterfeit as effectively as serialization. Bar codes increase the risk of being caught if counterfeits are present, whereas serialization uniquely identifies every entity and ensures absence of counterfeits. Serialization using bar codes as data carriers is a more secure strategy and is even more economical compared to RFID system.
Responding to the growing public health crisis of counterfeit drugs, the World Health Organization launched the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) to promote and strengthen international collaboration to combat counterfeit medical products.
Product serialization
Pharmaceuticals companies and governments of countries worldwide believe that counterfeiting by organized crime can be reduced significantly by implementing product serialization.
Serialization requires a comprehensive system to track and trace the passage of prescription drugs through the entire supply chain. Every product should be identified by a unique serial number in addition to the origin, shelf life and batch number. This will allow the product’s life cycle to be traced from production, through distribution and finally to dispensation to patients at the drug store or hospital.
The World Health Organization (WHO) estimates counterfeit drugs are approximately one per cent of the supply in developed countries and 30 per cent to 40 per cent in developing countries. Though the one per cent figure seems small, it consists of millions of prescriptions in the US alone.
There are various solutions available to rein in counterfeit menace. Technological protection is seen to be the best way to avoid this problem; Different technologies came into existence like overt, covert and track & trace technologies. Developed countries like the USA have implemented RFID while the European trend is towards 2D bar codes.
An ideal anti-counterfeit technology should possess a high level of security (non-clonable), higher+ product application and authentication speed, proven standards, be difficult to remove and re-apply, easy to check, have automatic authentication, be usable by consumers and must be legally compliant by the industries. However, it is recommended that the use of multiple, periodically changing, authentication measures on a product specific basis.
Tamper-evident/tamper-resistant packing; product authentication; holograms; track & trace technology; pedigree; mass serialization; global trade item number (GTIN); serialized global trade item number (sGTIN); data carriers are some of the current anti-counterfeit technologies.
Anti-counterfeiting market
The global pharmaceutical anti-counterfeiting market will grow at a compound annual growth rate of 13.6 per cent from 2014 to 2020, dipping to a still healthy 9.5 per cent CAGR between 2020 and 2026, according to a study.
The US and the EU dominated shares of the market in 2015. However, emerging markets will increase their market shares throughout the forecast period as the demand for such technologies will be greatest in areas where illegal counterfeiting is greatest. Much of the new legislation coming in over the next five years will be in the emerging national markets such as Brazil, India and Russia, the study points out.
According to some of the analysts, the increasingly global pharmaceutical supply chain will also act as a catalyst for growth in this market. Since China and India are among the largest exporters of pharma products, the growth in the anti-counterfeiting technologies market of these two big economies will boost the global market, they add.
The pharmaceutical anti-counterfeiting technology market will almost double in the next few years, rising from $3.4 billion last year to $6.5 billion by 2020, the study adds.
Though the technologies like RIFD, Taggants, Bar codes, Holograms/OVD and Others - notes that are still an emerging sector in pharma, but their use will expand quickly as "criminal activity associated with counterfeited medicines rises.
Africa, Asia and South America remain popular destinations for counterfeiting operations, notes the study but the problem is now widespread in developed countries too. Over the course of the forecast period, traditional bar code technology and new radio-frequency identification (RFID) technology will compete for market share, says the report.
This year the bar codes submarket holds the highest proportion with a market share of 29.8 per cent, and will grow at a CAGR of 6.5 per cent from 2014-2020 and 2.7 per cent from 2020-2026. RFID will be the fastest growing submarket from 2014-2020 with a CAGR of 22.3 per cent.
Holograms/optically-variable devices (OVDs) will start as the fourth and finish as the second leading submarket in 2026, while taggants - such as security inks or dyes, biological markers or nano- and micro-particle taggants - will finish as the smallest submarket.
Though the US, EU and Japan were the top three leading national markets in 2015, but the study predicts China will overtake Japan as the third largest market in 2020 and will be the fastest growing national market overall.
According to an analyst the introduction of tougher criminal penalties for counterfeiters coupled with government involvement demanding e-pedigrees on all pharmaceutical products will help to expand the anti-counterfeiting technologies market.
To implement anti-counterfeiting technologies on a global scale there must be cohesion between different national regulatory authorities, he added.
According to WHO, the cost of pharmaceutical counterfeiting to the global economy was estimated to be about $75 billion in 2010, and this figure exceeds the illicit drug trade by around 50 per cent ($50 billion).
The supply and distribution of counterfeit medicines is also growing exponentially (90 per cent increase when compared to 2005 figures) - the counterfeiting business is far more lucrative and less risky than illicit drug activities, with criminals less likely to be prosecuted than those engaged in illicit drug trafficking.
Security devices on pharmaceutical and healthcare products and packaging will ensure quality and check smuggled and illicit products, while items not displaying security holograms will be seized and destroyed.
The use of well-designed and properly deployed authentication solutions, as advocated in ISO’s 12931 standard, on authentication solutions, enables examiners to verify the authenticity of a legitimate product, differentiating it from the counterfeits coming out of China.
Even those that carry a ‘fake’ authentication feature can be distinguished from the genuine item if that item carries a carefully thought-out authentication solution.
Drug counterfeiting has become a worldwide problem. There is no country, which can deter the existence of counterfeit drugs in its pharmaceutical market. Counterfeiting or falsified medicines requires collaboration at national, regional and international levels between the law providers, enforcement agencies, manufacturers and suppliers. Health professionals and medical practitioners in particular have a crucial role to play in notifying patients to counterfeit medicines and educating them to detect their presence.