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Serialization and traceability mandates move forward there; anti-counterfeiting is also a focus
Noting that India’s export of generic pharmaceuticals has more than doubled from 2008, to $16.5 billion in 2014, and that the country itself represents a $26.4-billion market, Systech International is deepening its commitment to that market, even as it builds business in the US, where pharma packagers are under a November 2017 deadline to serialize their products with unique barcodes, and Europe is under a planned 2019 deadline for compliance with the similar Falsified Medicines Directive. First up in India is the company’s sponsorship of an invitation-only conference, the Uniquity Global Conference, in Mumbai on Oct. 6.
India’s Directorate General of Foreign Trade (DGFT) established an unusual requirement for serialization several years ago: All export products must be serialized in compliance with the US, EU and other mandates (domestic serialization will come later). “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," noted Dr. Avi Chaudhuri, who is spearheading Systech's India expansion. “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.”
Systech has been a longtime player in the serialization market, with its products for managing the barcoding process, collecting and verifying packaging data and reporting it to trading partners now branded as the Uniquity solution. Additionally, the company will be expanding efforts toward adoption of its UniSecure technology, which enables serialized products to be authenticated. (It bears mentioning that while the US and EU mandates minimize counterfeiting and diversion of products, they are not bulletproof solutions—there will still be a need in some cases for additional anticounterfeiting measures.)
Industry demand is for “globally-compliant solutions that meet the vast array of complex regulations that continue to evolve,” said Robert DeJean, Systech CEO. “As a result, there’s a need for solutions that are comprehensive, versatile, and cost-effective.”