The Indian Central Drugs Standard Control Organization (CDSCO) issued details of the firms it has issued with renewed written confirmations (WC) today.
Publication of the list comes days after industry group Pharmexcil suggested CDSCO’s “lack of manpower” could delay renewals and “hugely impact API exports to EU.”
Pharmexcil said it asked the “CDSCO to issue the renewals on the basis of their current USFDA, MHRA,EDQM or CDSCO approvals and conduct the inspection later as and when inspectors would be available from the central and zonal offices.”
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) would need to provide written confirmation their production sites meet with appropriate standards regardless of whether they have been inspected by the EDQM or 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.
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.
The first group of written confirmations which the agency issued to Indian API manufacturers in June 2013 were due to expire this month.
An EMA spokesman told us the CDSCO is permitted to renew written confirmation documents without conducting new inspections, citing a European Commission questions and answer document published last year.