‘Serialisation can analyse business value’ | Shashikant Joag, Technical Consultant, SynergyPharma Formulations India
The world is full of complex situations and almost every matter has two sides either brighter or darker in common sense. However, when it comes to medicines it is decidedly serious as it relates to health in general and life in particular of humans and animals. Existence of Falsified Medicines over the pharmacy counter thus has remained a grave concern for regulators all over the world. Until recently, the most frequently falsified medicines in wealthy countries were expensive ‘lifestyle medicines’ and high value ‘Branded medicines’ but the criminal and greedy elements of the society have now included medicines to treat ‘life-threating conditions’ also. The phenomenon of falsified medicines is on increase and hence dangerous to the human and animal life. To fight with this menace the regulators are constantly thinking of identifying ways and means to weed out falsified medicines from the market and ensure that authentic, authorised, safe and quality medicines will be available to the patients.
In November 2013, the Federal government in the United States passed the Drug Quality and Security Act to create a national pharmaceutical serialisation and track and trace regulation. The act is designed to hinder the production and distribution of life threatening imitation or counterfeit pharmaceuticals. The act demands identification and authenticity features on primary, secondary and tertiary packaging levels in the form of unique, non-predictive, serialised and machine readable codes. The serialisation can also provide opportunity to view and analyse product movement data and business value.
On February 9, 2016 the European Commission also published delegated regulation that introduces two safety features to be placed on the packaging of most human medicines a unique identifier( a two-dimension barcode) and an anti-tampering device. Marketing authorisation holders must place these on the packaging of prescription medicines from February 9, 2019. EMA and the European Commission have prepared an implementation plan including regulatory requirements and timelines, to guide applicants and marketing authorisation holders in meeting these requirements. Supply chain and good distribution practices for wholesalers and brokers have also been introduced by the Directive. The European Medicines Verification Organisation (EMVO) a Belgian non-profit organisation representing stakeholders united will help in securing the legal supply chain from falsified medicines.
The EDQM in 2006 has also set up a data repository for network members involved in the testing of counterfeit / falsified and illegal medicines. This information platform is used by the Official Medicines Control Laboratories (OMCLs) on a voluntary basis to make test reports available in a standardised format. It allows network members rapid exchange of information on testing activities in the area of falsified medicines. In 2014 the data repository was replaced by a more advanced database ‘KnowX’ which now collates test reports from OMCLs and reports issued by customs, police and health authorities on falsified medicines. The CDSCO in India has also planned to create a working group to critically appraise its proposal to set up a ‘trace and track’ mechanism to identify fake medicines from the market using a 14 digit unique code number on the product pack based on recommendations made by Drugs Technical Advisory Board.