A new directive from the European Union (EU) passed on June 8 to prevent sales of ‘falsified drugs', or drugs that fake their identity, origin or distribution history, is set to give pharmaceutical exporters a headache.

The directive assumes significance for India as about 15 per cent of the $10.3-billion pharmaceutical exports as on March 31 were to Europe.

The directive, framed by the European Parliament and the Council of the EU, prescribes that organisations or individuals involved in packaging of medicinal products should have an authorisation.

“There is an alarming increase of medicinal products detected in the Union which are falsified in relation to their identity, history or source,” the directive observed.

The directive also requires that all medicines be covered by a marketing authorisation as the falsified products are making it to EU markets through legal as well as illegal channels.

It makes it mandatory for everyone involved in sales of medicines to be registered with the national authorities in the EU.

The holder of the authorisation will have to follow ‘good manufacturing and distribution practices' whereby it will have to conduct audits at manufacturing and distribution sites, the directive says.

There should be an ‘anti-tampering' device that will help verify whether the outer packing of medicines has been tampered or not.

Measures to tackle fraudulent drug sale through Internet will also be put in place.

“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,” Dr P.V. Appaji, Executive Director, Pharmaceutical Export Promotion Council, told Business Line here.

When contacted, pharma experts from some companies that export to Europe said a detailed impact analysis would take some time.

Provisions of the directive will come into force in about one to two years.

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