“As per the Directive of EU countries, we need to implement FMD. In case of UK, we need to comply to the FMD requirements before February 2019. Hence, it has become important for companies dealing with Europe and UK, to invest in FMD although it will add to the cost, not only by way of initial investments, but also recurrent payments to the service providers. This has to be done in spite of lowering margins for generics in highly competitive environment.
Our company Fourrts has already made the necessary plans and we are hopeful of being FMD ready before November 2018. I am sure, other companies also need to do the necessary compliance, so that their exports are not affected.
The advantage of EU FMD implementation may result in better traceability and avoid spurious or non registered drugs. The disadvantage will be the additional cost involved and slowing down of production. The advantage of serialisation is also not fully established.”