Renewal of Indian WCs for API exports to EU urged

9 June 2016

There is an urgent need for renewal of Written Confirmation (WCs) issued by the Drug Controller General of India (DCGI) for active pharmaceutical ingredient (API) exporters to the European Union, according to Brand India Pharma.

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 India’s Ministry of Commerce and Industry and the 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 the EU, says Brand India Pharma.

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