Under the falsified medicines directive, from July next year active pharmaceutical ingredients (API) made outside the European Union (EU) for the European market must be manufactured to standards equivalent to the region’s good manufacturing practices (GMP) regulations.
The rules also state that a non-EU exporter’s compliance with appropriate manufacturing standards must be confirmed in writing by local regulators, unless the country in question is granted exemption for the rules.
To date only Switzerland and Israel have asked for exemption from such requirement – neither of which has been approved – and it is unclear at this stage with any other countries will ask for similar treatment ahead of the July deadline.
Opposition
However, the rules have already raised some concerns. In March, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) said that it worried about how the July 2013 deadline the EU has imposed will impact manufacturers in countries that supply the majority of the APIs used in Europe.
“There is very little time before implementation to engage with exporting countries: we would urge that the Commission does this as quickly as possible to discover how the main exporters especially China and India intend to take action to secure supply routes.”
The comments were followed a few months later by speculation and various media reports that India and China - which supply around 80 per cent of Europe's APIs - would team up to appeal against the EU laws on the basis that the breach of the World Trade Organisations (WTO) barrier to trade provisions.
This scenario - for India at least - now appears to be less likely following a meeting of the Pharmaceutical Export Promotion Council of India (Pharmexcil) and representatives from the Indian Ministry of Health that took place last Thursday.
According to a report in The Hindu Business Line earlier this week, Pharmexcil DG PV Appaji said that: “The Government will appoint the required competent authority in two weeks. Our compliance with the new EU norms will be completed well before the July deadline.”