Mumbai : The Central Drugs Standard Control Organisation (CDSCO) has directed active pharmaceutical ingredient (API) manufacturers to file online applications for issuance of written confirmation certificate (WCC) on the new SUGAM module. For exporting APIs to European Union (EU) countries, a written confirmation certificate is must.
The certificate was made mandatory by the EU in 2013 which confirms the compliance of good manufacturing practice (GMP) as per EU standards.
CDSCO in pursuance to implementation of the e-governance mechanism has launched various online services through the SUGAM portal on November 14, 2015. In continuation to same, CDAC in collaboration with CDSCO has developed a module for online processing of applications for issuance of written confirmation certificate as per 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, said Drugs Controller General of India Dr VG Somani.
The module has been made functional, which can be accessed through https://cdscoonline.gov.in. All concerned stakeholders are requested to avail this facility and any suggestions to help improve the module shall be addressed properly, Dr Somani said.
No physical application for issuance of WCC will be accepted from July 24, 2021 in this regard, he informed.
The EU mandated the written confirmation certificate to prevent falsified medicinal products from entering the EU from other countries.
The written confirmation certificate confirms the compliance with GMP standards or rules, equivalent to the rules applied in the EU. The ministry of health and family welfare, government of India, has nominated CDSCO as the competent authority for the purpose of issue of written confirmation certificate.
The EU has reformed the rules for importing into the EU active substances for medicinal products for human use. As of 2nd January 2013, all imported active substances must have been manufactured in compliance with standards of GMP at least equivalent to the GMP of the EU. The manufacturing standards in the EU for active substances are those of the ‘International Conference for Harmonisation’ – ICH Q7.
The compliance must be confirmed in writing by the competent authority of the exporting country. The document must also confirm that the plant where the API was manufactured is subject to control and enforcement of good manufacturing practices at least equivalent to that in the EU.
The certificate states that the standards of good manufacturing practice 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 good manufacturing practice, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in the EU.
