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CDSCO renews WC certificate to API units to ease export to EU countries
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Swati Rana, Mumbai
June 28 , 2016
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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.
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