India's drugmakers 'will struggle to meet DSCSA deadlines'

Around half of all India's pharma companies face losing market share in the US because they are unlikely to meet medicine traceability mandates, claims an industry expert.

Arjun Guha Thakurta of Life Science Consulting tells Indian trade journal Pharmabiz that with the deadline for implementation of second phase of US Drug Supply Chain Security Act (DSCSA) just over a year away, drugmakers are struggling to meet the level 3 (site level software and hardware) and level 4 (business logistics systems) requirements.

If that level of non-compliance is evident by the next deadline in November 2017, it will raise a question mark over India's ability to serve the US market - or the ability of the US authorities to enforce compliance without risking drug shortages. As it stands, North America is the destination for more than a quarter of India's pharma exports.

Thakurta says that meeting the 2017 serialization requirements will require Indian drugmakers to implement "a slew of upgrades of existing lines and make additional investments into aggregation lines and reporting software." For smaller manufacturers that is a significant problem, he suggests.

The DSCSA was signed into law by President Obama in November 2013, setting a 10-year deadline to implement an individual package level system to track medicines through the supply chain and allow them to be verified using the unique product identifier.

Phase I came into effect on January 1, 2015, requiring pharma manufacturers and other supply chain actors to start recording transaction histories at the lot level, in either paper or electronic format, but the next phase is considerably more challenging.

From November 27, 2017, serialisation becomes a requirement with drug manufacturers having to add a unique product identifier to each package and homogenous case of a product introduced into commerce.

Manufacturers must provide transaction information, history, and statement in electronic format and respond to trading partner’s request for product identifier information within 24 hours. In November 2018 those requirements will apply to repackagers, a year after that wholesale distributors must comply and in 2020 dispensers such as pharmacies come into scope.

According to Thakurta, unless manufacturers have serialization in place for levels 1-4 they will not be able to respond to the request of wholesalers and repackagers within the stipulated time.