CDSCO renews WC certificate to API units to ease export to EU countries

The Central Drugs Standard Control Organisation (CDSCO) has started renewing the written confirmation (WC) certificate to active pharmaceutical ingredients (API) manufacturers for exporting APIs to European Union (EU). The certificate was made mandatory by EU in 2013 which confirms the compliance of good manufacturing practice (GMP) as per EU standards with the validity period of 3 years. Most of the companies have completed the validity terms and approached CDSCO for renewal.

Approximately 30 companies have received the renewed written confirmation certificate to export APIs to the EU countries. The EU mandated the written confirmation certificate to prevent falsified medicinal products from entering EU from other countries.

An official from CDSCO says, “We have started issuing the renewed written confirmation certificate as most of the companies have completed the validity of the certificate this year. The written confirmation certificate is issued to the companies since May, 2013 as mandated by EU. For exporting the APIs to EU countries, written confirmation certificate is must and we are receiving application from the companies for the renewal.”

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 2 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 active substance 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 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.

Source: Pharmabiz