Domestic drug manufacturers in India are concerned as the European Union (EU) is all set to issue a new directive on falsified medicinal products from July 2013 to check import of counterfeit medicines. Under the directive, companies supplying active pharmaceutical ingredients (API) have to submit equivalence certificates to the European authorities to prove the quality of their products.
According to the Pharmaceuticals Export Promotion Council of India (Pharmexcil) lobby group, India exports a total of around Rs 10,769 crore of drugs to EU annually and if companies fail to get an EU equivalence certificate by 2 July 2013, 30% of this could be affected.
Industry officials say currently India does not have the infrastructure and manpower to comply with the new directive.
However, various industry bodies are trying to lobby with the government and international bodies like World Trade Organisation to get a concession for the Indian companies to be able to continue their exports.
Under the EU falsified medicines directive, each shipment of active pharmaceutical ingredient (API) or drug raw materials from India should be accompanied with a written confirmation, vouching that the quality of the exports conforms to EU standards. The legislation was adopted by the EU Council in May 2011 with the objective of preventing the entry of fake drugs.