DCGI directs API manufacturers to submit applications online

All Zonal and Sub-Zonal Offices of CDSCO have also been intimated the same.

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DCGI CDSCO

Last Updated on September 12, 2021 by The Health Master

The Drugs Controller General of India (DCGI) has directed bulk drugs manufacturers to submit applications online of already issued valid Written Confirmation Certificate (WCCs) through “Historical” mode in the new module of SUGAM portal.

Centre for Development of Advanced Computing (CDAC) in collaboration with Central Drugs Standard Control Organisation (CDSCO) has developed a module for online processing of applications for issuance of WCC as per the requirement of EU for import of APIs into the EU region for medicinal products for human use, in accordance with Article 46b(2)(b) of Directive 2001/83/EC.

All Zonal and Sub-Zonal Offices of CDSCO have also been intimated the same.

VG Somani DCGI
Dr. VG Somani, DCGI

According to the DCGI Dr. V. G. Somani, “The module is functional now. Suggestions and comments received from stakeholders have been incorporated to help improve the module which is part of the SUGAM portal.

Such applications are compulsory from IT perspective for issue of WCC for endorsement of products in existing WCC.”

The WCC is compulsory for exporting active pharmaceutical ingredients (APIs) to European Union (EU) countries. WCC which was made mandatory by the EU in 2013 confirms the compliance of good manufacturing practice (GMP) as per EU standards.

The module can be accessed through https://cdscoonline.gov.in.  The EU mandated the WCC to prevent falsified medicinal products from entering the EU from other countries.

The WCC confirms the compliance with GMP standards or rules, equivalent to the rules applied in the EU. The union health ministry, Government of India has nominated CDSCO as the competent authority for the purpose of issue of WCC.

The WCC states that the standards of GMP applicable to a manufacturing plant are at least equivalent to those laid down in the EU.

The manufacturing plant is subject to regular, strict and transparent controls and to the effective enforcement of GMP, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in the EU.

CDSCO in pursuance to implementation of the e-governance mechanism had launched various online services through the SUGAM portal on November 14, 2015.

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