The European Union (EU) Falsified Medicines Directive (FMD), 2011/62/EU which will be enforced from January 2, 2013 is now of particular concern for Indian active pharmaceutical ingredient (API) industry. Now the government of India is planning to conduct feasibility check to train its drug inspectors on EU standards.

There is an alarming increase in falsified medicinal products (FMP) although its extent is not confirmed. Now the European Commission's (EC) Directorate helps to prevent entry of FMP into the legal supply chain.

The EU rule insists that all imported active substances need to be manufactured in compliance of good manufacturing practices (GMP) adhering to International Conference for Harmonization (ICH Q7) and imported on certification by the competent authority of the exporting country.

The EC order appears impracticable for implementation. Although the apprehension that each shipment of APIs from India should be certified has been removed through an EU Q&A document in October 2012, it now states that API manufacturing plant needs to be certified instead of each API. Of course, more clarity is found wanting before its implementation, pointed out SM Mudda, executive director (Technical & Operations), Micro Labs Ltd, director ISPE India and chairman – IDMA Regulatory Affairs Committee.

Execution of the directive requires knowledge of the EU GMP and practical experience, along with capacities and resources, he added.

Based on the similar experience in the past, industry is apprehensive that, although the directive pertains to APIs, the term ‘falsified’ could apply to generic drugs made in India. Now if an Indian company manufactures a generic version of a drug patented by a multinational company, it could come under this directive and be treated as a ‘falsified’ or spurious drug and be confiscated.

“The EU initiative citing the reasons of safety appears to be protectionist and may perhaps act as an economic barrier for India. In 2010-11, India’s drug exports to the EU were $1.93 billion (around Rs.10,769 crore). If India fails to comply with the EU equivalence certificate by July 2, 2013, when the rule is set to take effect, 30 per cent of the companies could be affected, said Mudda.

The Directive defines FMP as any medicinal product with a false representation of its identity, packaging, labelling, name, ingredient composition including excipients. It now mandates mention of source, including manufacturer, country of production, marketing authorization holder, records and documents of distribution channels used. The quality would be certified by the National Competent Authority (NCA) of the third country. Even the Finished Product Manufacturers need to ensure EU GMP compliance of API used. EU-based Indian API manufacturers, importers & distributors should register with the Competent Authority 60 days prior to commencement of their activity. Those already in operation have to submit their registration by March 2, 2013.

The directive also provides for exceptions of written confirmation to the countries certified by the commission. Few countries like Singapore, Australia, Israel, Brazil, Switzerland have made their application for exemption. It is therefore important to see whether India would like to seek exemption, in which case the regulatory framework of India has to be brought on par with global standards and the industry needs to adopt Quality System and Risk-based approaches for GMP compliance. EU regulatory agencies and WHO are willing to provide necessary support for capacity building in India, pointed out Mudda.

Effective implementation of the current measures should be the first option to explore rather than going for additional controls because only this would lead to an increase in drug costs without corresponding benefit of control on quality. Now Whether EC 2011/62 directive increases the patient safety with regards to falsified medicines in conjunction with the import restrictions remains questionable, stated Mudda.