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Swissmedic welcomes EC ruling on APIs; CDSCO to oversee Indian exports to EU

By Gareth Macdonald , 06-Dec-2012
Last updated on 07-Dec-2012 at 16:30 GMT

Pharmaceutical industry regulator Swissmedic says inclusion on EU third-country list illustrates the high quality of APIs made in the country.

Last week the European Commission (EC) said that active pharmaceutical ingredients (APIs) made in Switzerland do not need to be shipped with written confirmation’ of quality from local regulators after deeming that the country's manufacturing standards meet its requirements.

Lukas Jaggi, a spokesman for Swissmedic, told in-pharmatechnologist.com the decision only applies to APIs that are produced in Switzerland rather than any exported to the EU through the country, which will still need to be accompanied by ‘written confirmation’ of quality.

He also said that the EC's decision “shows that the Swiss medicines control system has a high standard,” and agreed that it will save the regulatory agency time and money.

Swissmedic does not keep data on the number of Swiss made APIs that are exported to Europe each year. However, data from the DCG suggests that the value of drug and API exports to the European Union have been stable at around CHF35bn (€28.9bn) since 2008.

Indian API exports

In related news, reports suggest that India’s Drug Controller General (DCGI) and the Central Drugs Standard Control Organisation (CDSCO) will take charge of assessing API makers and issuing written confirmation for those wishing to export to the EU

According to Express Pharma report from late Novermber  .N. Singh, the current DCGI, confirmed his role and the involvement of regional CDSCO offices in the assessment process and said his organisation is drafting guidelines to enable this certification.

PV Appaji, Director General, of industry organisation Pharmexcil – who hinted that India would pass oversight of the quality of EU-bound APIs to a ‘competent authority’ in September – welcomed the development.

He told the publication that: “Industry is anxiously awaiting these guidelines as they are crucial to pharma exports to the EU.”

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