 "Carbogen Amcis' facility in Bubendorf (Switzerland)")
To keep a check on counterfeit drugs, pharmaceuticals companies and governments across the world are implementing product serialisation - a comprehensive system that helps in tracking and tracing the passage of prescription drugs through the entire supply chain. As governments in the developed countries, such as US and Europe, make it mandatory for pharmaceutical industry to implement serialisation, Indian companies are increasing looking at adopting the technology.
In response to a growing need for its solutions and an expanding client base in the region, Systech International, a global leader in serialisation, traceability, and brand protection technologies, recently established an office in Mumbai.
“With the incredible opportunity to service the pharmaceutical industry comes the demand for globally-compliant solutions that meet the vast array of complex regulations that continue to evolve. As a result, there’s a need for solutions that are comprehensive, versatile, and cost-effective. Systech’s industry-leading serialisation and track-and-trace offerings have been proven for more than 30 years as the best solutions to meet this need,” commented Robert DeJean, CEO, Systech International.
Pharmaceutical manufacturers in India supply a huge volume of high-quality medicines to every market in the world, and the nation’s pharmaceutical export segment has more than doubled from $ 7.8 billion in 2008 to $ 16.5 billion in 2014, according to the Indian Ministry of Commerce and Industry. In 2016, sales are expected to increase by nearly 84 percent to $ 26.1 billion with generic drugs dominating, accounting for nearly 70 percent of the market. Furthermore, over 55 percent of exports from India are to highly regulated markets whose governments have enacted stringent serialisation and tracing regulations.
“The problem is that no two of these regulations are the same, and therefore Indian exporters must not only comply with all the individual mandates, but also keep abreast of a rapidly-changing regulatory landscape. Our core commitments to the industry are that we provide a comprehensive set of solutions and ensure full compliance against any and all new regulations that come into force,” noted Dr Avi Chaudhuri, who is spearheading Systech’s India expansion.
Systech International offers a full suite of software applications to manage these complex requirements, allowing serialisation mandates to be met anywhere in the world - including the export serialisation requirements of the Indian Directorate General of Foreign Trade (DGFT). Systech is already seeing significant demand for its solutions as Indian pharmaceutical companies rush toward complying with the looming deadlines for key regulations such as the US DSCSA (Drug Supply Chain Security Act), EU FMD (Falsified Medicines Directive), and others.
According to Harry Saint-Preux, director, global alliances & channels, “Systech is the only provider in the world that offers a complete palette of solutions encompassing serialisation, aggregation, reporting, rework, and enterprise traceability. Companies that implement Systech’s stack obtain a unified solution to cover the entirety of pharmaceutical requirements. This unique capability increases the value we bring to our clients.”
The demand for Systech’s services in India is also due to the versatility of its offerings. By being hardware-agnostic, Systech can collaborate with a multitude of local vendors and integrators who have served the Indian market with distinction. Many pharmaceutical companies have already made significant investments in line-level hardware. Systech can work with such existing setups to preserve those past investments, and therefore deploy only the subset of its highly configurable solutions that would be needed to complete the task toward DSCSA or other regulatory compliance. This in turn makes for a highly economical offering to its prospective clients.
The combination of advantages offered by Systech also makes it particularly attractive to contract manufacturers and packagers. Mid-market companies that offer services to other drug manufacturers must develop and follow a program of adding multiple serialisation-related capabilities to all of their packaging lines within the next 15 months, or risk losing their business to competitors who are DSCSA-compliant. Systech’s product suite is extremely attractive to the Indian SME sector because it is designed to work with a wide array of packaging and labeling equipment to ensure cost containment.
In addition to its serialisation and traceability solutions, Systech is also introducing its highly acclaimed brand protection technology, UniSecure. Pharmaceutical and consumer brands are major targets of counterfeiters in Asian markets. UniSecure offers a unique approach to global brand protection due to its immunity from many of the problems that affect other anti-counterfeiting solutions. As an example, UniSecure does not require brand owners to fit any printers on the packaging line, or to make major investments for variable coding.
Chaudhuri explained, “The biggest benefit to UniSecure is its non-additive and non-intrusive technology, instead using an existing overt mark already produced during packaging - such as a linear barcode - to create a unique covert identifier. The UniSecure technology does not require addition of any print matter on a package, and yet it can be used with serialised barcodes to create a highly robust solution that simply cannot be copied or reverse-engineered. In effect, it serialises a non-serialised product and, in doing so, averts all of the security issues that have been problematic with use of mass serialisation purely for brand protection.”
To further support its entry, Systech will convene its next Uniquity Global Conference in Mumbai on October 6, 2016, featuring a roster of prominent guest speakers. The conference will focus on global serialisation regulations affecting the pharmaceutical industry and how effective technologies will be necessary to meet a wide range of compliance requirements.
