India to allow API firms to request EU quality confirmations online

By Gareth Macdonald

- Last updated on GMT


Related tags European union

Indian regulators will allow API firms to seek the confirmations needed to ship to the EU online from next month.

The Central Drugs Standard Control Organization(CDSCO) outlined the plan in a note​ this week, explaining the aim is to streamline the application process for written confirmations to facilitate “ease of doing business.”

 “Written confirmation”

In 2011, the European Commission set out its rules on the importation of active pharmaceutical ingredients (API) in Directive 2011/62/EU​.

The directive was part of a wider effort to ensure that fake and substandard ingredients do not enter the supply chain.

A central requirement was that API manufacturers outside the European Union (EU) should provide written confirmation their production sites meet with standards regardless of whether they have been inspected by regulators from an EU member State.

API firms have needed to send these written confirmations with each batch shipped to Europe since July 2013.

The only exception is if the manufacturer in question is located​ in a country where standards have been deemed to be equivalent to those in eht EU.

India was not granted this exemption, which meant that since 2013 CDSCO has had to inspect the manufacturing operations of companies seeking to tap the European market.


Active pharmaceutical ingredient (API) manufacturers will also be able to apply for Certificates of Pharmaceutical Products (CPP) – which certify a products’ quality for importing countries – via the same portal.

The note also states inspections of applicants’ manufacturing facilities will be carried out by authorities in the relevant state with assessment tools provided by the CDSCO.

The CDSCO did not respond to a request for further information.

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