A new directive released by the European Union on June 8, prohibits pharmaceutical exporters from marketing or selling “fake drugs,” or drugs that falsify information regarding their origin, identity, and distribution history.
The decree has been drafted by the European Parliament and the Council of the EU, and is of immense significance to India since Europe imports nearly 15% of India’s $10.3-billion pharmaceutical exports (Figures as of Mar.31).
According to the directive, only authorized individuals or companies must be involved in the packaging of medicinal products.
The directive noted, “There is an alarming increase of medicinal products detected in the Union which are falsified in relation to their identity, history, or source.”
Furthermore, the directive mandates the marketing authorization for all medications because fake products are swarming their way into the EU markets by legal and illegal means.
The national authorities in the EU note that it is imperative for everyone involved in the marketing of drugs to be listed with them.
The directive emphasizes that all individuals or companies in possession of the authorization will have to comply with “good manufacturing and distribution practices” and perform inspections at their manufacturing and distribution units.
In order to authenticate whether the outer packaging of the medication has been messed around with or not, there is a need to introduce an “anti-tampering” device. Internet-based fraudulent drug sale will also be tackled with by applying appropriate measures.
Executive Director, Pharmaceutical Export Promotion Council, Dr P.V. Appaji said, “Except the system of barcoding on pharma exports, which will be in force from October, pharma companies need to gear up to meet the requirements mentioned in the directive.”
Certain experts from pharma companies say that it would take a while before conducting a detailed analysis of the drug export to Europe.
The directive is said to be implemented in the next one or two years.