Pharma companies across the world are racing against time to meet the November 2017 deadline of the US DSCSA followed by the February 2019 deadline of the EU Delegated Act. Are Indian companies ready for the complexities of serialisation? By Viveka Roychowdhury
By the end of this decade, industry estimates indicate that more than 80 per cent of all pharmaceutical products available globally will have rolled off a packaging line that has serialisation at the tertiary level, i.e. bottle/ strip/ vial level. Some companies are well on track to meet these deadlines. For instance, in late June, Recipharm, a global contract development and manufacturing organisation (CDMO), announced the formation of a global partnership with Marchesini, SEA Vision and TraceLink to introduce new serialisation capabilities. According to a press release, this marked the next step in the global CDMO’s plans to invest €40 million over the next three years to ensure state-of-the-art solutions for serialisation processes.
However, Kjell Johansson, President Manufacturing Services Europe, Recipharm sounds a cautionary note for pharma companies in India. He says, “In general, pharma companies need to place serialisation higher up on their agenda in order to meet the US and EU deadlines. Many companies are not currently aware of the scale and complexity of the task ahead. While the EU 2019 deadline is three years away, the European Stakeholder Model (ESM) suggests that four to five years is a more realistic time-frame. As many manufacturers have a number of markets they need to address, ranging from the EU and US to South America and Asia, there is a degree of legislative complexity that must be effectively managed and this will be a challenge for pharma companies in India. Many companies are also concerned about the financial investment involved. Hence, our novel pricing model to reduce upfront investment costs.”
Most of the bigger Indian companies are gearing up to the serialisation challenge and this is attracting global serialisation solution providers like Optel Vision to expand their presence in the country. (See story on pages 35-38). The good news is that solution providers are tailoring their products for the India market. For instance, in partnership with a top-ten global pharma company, Antares Vision, yet another provider of serialisation-based track and trace solutions, which is reportedly currently in the process of launching a pilot project in India, is developing a leaner, more cost-effective serialisation solution for the Asian subcontinent that performs onpar with European standards and mandates. The goal is to implement track and trace in India that is forward-thinking in terms of ‘pre-meeting’ inevitable regulatory requirements, according to the company.
Will these offerings convince pharma companies in India to commit to serialisation?