Renewal of WCs for API exports to EU: Need of the hour

There is an urgent need for renewal of Written Confirmation (WCs) issued by the Drug Controller General of India (DCGI) for API exporters to EU.


June 08, 2016: The WCs have been issued since July, 2013 due to the directive of falsified medicines, when it was mandated that all APIs used in medicinal products would need to be attested by WCs stating that each API unit is compliant with Good Manufacturing Practices (GMP) or similar rules applied in the EU. The move has been a result of collaborative efforts of the Ministry of Commerce and Industry and DGCI and has been issued with a three year validity.


There is a growing concern in the pharma industry circles that due to lack of manpower in DGCI offices, delay in renewal of such certificates would hugely impact API exports to EU. The Pharmaceuticals Export Promotion Council (Pharmexcil) representing the industry has requested 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. It has been suggested that the renewal details should be displayed on the website to ensure transparency and accessibility for EU authorities or anyone interested for such details.


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