It is human nature to perceive change as a threat. But turning this threat into an opportunity is a crucial skill. Take for example, Brexit. After the initial knee jerk reaction, which included plunging share prices of corporations seen to have a large UK presence, countries and companies seemed to be adjusting their sails. Read our cover story ‘Brace for Brexit’, in the August 1-15, 2016 issue for a detailed analysis of Brexit on Indian pharma companies and how some are now waiting to seize the advantage. Isn’t it ironical that as we celebrate our 70th Independence Day, we have a cover story on UK’s independence from the EU!
The war against counterfeit medicine is another example of how a threat (capital intensive anti counterfeiting measures) will eventually become an opportunity to create a sharper business edge for early adopters. In the past few years, more than 20 countries, including India, have rolled out serialisation/ track and trace mandates. Measuring upto these mandates could change the pecking order in the pharma industry, which is why the current Express Pharma August 1-15, 2016 issue has a section on serialisation.
In ‘Race against time’, Kjell Johansson, President, Manufacturing Services – Europe, Recipharm, a global CDMO, cautions that in general, pharma companies need to place serialisation higher up on their agenda in order to meet the US and EU deadlines. The deadlines may seem far away (November 2017 for the next phase of the US Drug Supply Chain Security Act (DSCSA)) Implementation Plan and February 2019 for the EU Delegated Act, to name just two mandates) but considering the complexity of multiple regulations from different countries, smaller CDMOs might be forced to prioritise markets and might lose out.
As a specialist in computerised system validation and serialisation project management, Arjun Guha Thakurta, Director-Operations, Life Science Consulting highlights the compliance deadlines looming ahead and more importantly the project bottlenecks in his article, ‘Serialisation World – A global regulatory canvas’. He estimates that there are less than 20 track and trace vendors and thus the rush to book their services and personnel could see the laggards struggle to start/ progress their serialisation projects.
Shaunak J Dave, Asian Market Director, Optel Vision, one of these vendors, applauds the sea change in the awareness and commitment levels in Indian pharma companies over the past six years. But in his article, ‘Challenges of global track and trace: Holistic approach, common solution’, he also cautions that the lack of time calls for immediate action. Most global serialisation vendors have created customised solutions by tweaking products and services. For example, Antares Vision, another such vendor, is currently launching a pilot project in India for a top-ten global pharma, which is a leaner, more cost-effective serialisation solution for the Asian subcontinent that performs on par with European standards and mandates. Express Pharma will feature case studies on such projects in forthcoming issues because we’re confident India Pharma Inc will rise to this challenges as well.