The European Fine Chemicals Group (EFCG) is insisting for compulsory audit of the active pharmaceutical ingredient (API) manufacturers from developing economies like India and China. The Group is of the view that the new Falsified Medicines Directive (FMD) would not be useful to ensure the  quality and safety standards of the APIs imported into the European Union (EU) from these countries.

In this regard, EFCG which is an active European Industry Group has published a paper which pinpoints the factors that need to be taken care of by EU which would be enforcing the FMD in the first half of 2013.

According to EFCG, “The EU has been depending on Asian suppliers for generic APIs and pharmaceutical products. Many companies from these regions have been operating manufacturing plants that have never been inspected by the EU authorities and are unlikely to meet the required EU GMP standards for many years to come.”

Further, EFCG disputes that the new FMD (2011/62/EU) designed to minimise counterfeit medicines entering the EU market does not adequately address the API quality issues and that in reality it does little to improve upon the present Directive (2001/83/EC). To support the call for action, the EFCG communication appends a list of hard evidence of illegal API manufacturing activity in Asia since 2003, the most quoted being the 2008 Chinese-sourced heparin case in the USA that caused over 100 deaths due to a deliberately included and undeclared impurity, indicated the paper.

“Over the past decade, driven by the need of national health services for cheaper medicines, the market for generic APIs has increased dramatically. Today, about 70 per cent of all API’s consumed in Europe are imported from China and India, where plants are rarely inspected for compliance with EU standards by EU authorities,” reported the EFCG paper.

“This has led to certain unregulated API manufacturers in developing countries, especially in China and India, to compete aggressively in the market with ~30 per cent lower prices due to lower labour costs and non-compliance with local environmental and safety regulations, for an API quality often less than the required EU standard. It is difficult for an EU customer to trace the real manufacturer of the API, because the original manufacturer, who initially certified the product, now uses another, lower cost, uncertified API manufacturer to supply them for export to the EU,” stated the EFCG paper.

The EFCG stated, “The new FMD (2011/62/EU ) does not require either mandatory inspection of all global API manufacturers for GMP compliance, or the traceability of the manufacturing sites that produce APIs sold in the EU. Instead, the responsibility to verify compliance remains with the EU Manufacturing Authorisation Holder auditing the supplier themselves or via a third party. There is a difference between regulatory approvals between EU  and national authority.”

According to senior industry officials, this paper by EFCG reaffirms the need for Indian regulatory authorities to speed up their efforts to have a common understanding of guidelines with the support of EU regulatory authorities.