In less than four months, by February 9, 2019 the Falsified Medicines Directive (FMD) will be implemented in more than 30 countries in the European Economic Area. It imposes strict serialisation requirements on pharmaceutical manufacturers, distributors and dispensers. However, companies are slightly apprenhensive about outsourcing serialisation to partners and ensuring compliance. The long terms strategy would be to see beyond the February 2019 deadline to see how partners can help optimise supply chain management given these new data requirements. Usha Sharma finds out more
‘Need of the hour is to regulate 2D bar-coding machinery and software’ | Dr Dinesh Dua
In my considered opinion, this is akin to what we have been experiencing in terms of 2D bar-coding in India, which has been postponed for a while particularly on account of cost considerations besides complete collapse of DAVA portal which has been proved to be a big deterrant. However, in the case of the Europe situation it is different and we don’t foresee any chances of deferment of this decision under any circumstances.
It’ll be in interest of the Indian pharmaceutical industry which is predominantly in Europe either to get organised for this, failing which exports to EU will get severely affected.
As Chairman of Pharmexcil, this is my personal and professional endeavour to disseminate this message to all Pharmexcil member companies to start gearing up for compliance to this upcoming regulation.
A word of caution here is about getting the right equipment and software support, which in the past has proven to not only mislead user industry but also has a hidden agenda of hiding cost in the initial offers and ballooning it up after a year or two under the pretext of ‘Software Upgrade’ which accounts to an virtual arm twisting and is also prohibitively expensive. Pharmexcil will reach out to its parent Ministry of Commerce to help contain and regulate these malpractices to ensure that the pharmaceutical industry gets a fair deal as has happened in case of several pharmacos.
To sum it up, the time has come for the Indian pharmaceutical industry to completely gear up for Post Marketing Surveillance (PMS) and also for the track and trace of the medicines supplied across the globe which sooner or later shall become harmonised all over the world particularly in North America, Europe, Japan, Korea, South Korea, Brazil, Mexico and emerging markets followed by African countries and rest of the world. Need of the hour is to regulate 2D bar-coding machinery and software and to make sure equipment manufacturers offer competitive prices and excellent quality as per global standards.
Next article – ‘It is a major step for anti-counterfeiting’ | Parag Kothari
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