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Govt issues new guidelines for API exports to EU

24 May 2013 Evaluate

In order to comply with the European Union (EU) Good Manufacturing Practice (GMP) standards and to boost pharmaceutical exports to the EU, the government has issued new guidelines on the same, which will come into force from July 2. This move is expected to have a positive impact on the companies aspiring to export to developed countries.

Ministry of Commerce and Industry in a statement said, ‘India has demonstrated its keenness to meet international requirements for exports of pharmaceutical products yet again by taking timely action for complying with the new procedural requirements of the EU for export of Active Pharmaceutical Ingredients (API) into the EU.’

The new legislation requires a written affirmation by a competent authority nominated by the government that the API has been manufactured in accordance with EU GMP standards. Further, written confirmation is also required about the manufacturing facility where the API was manufactured is subject to control and enforcement of GMP standards and is equivalent to those in the EU countries.

On November 12, 2012, the Department of Health & Family Welfare officially declared the Central Drugs Standard Control Organization (CDSCO), to comply with the above requirements. It was also decided that a protocol for the procedure to be complied by the India API Exporters would be laid down by CDSCO, which has been done.

Earlier, on June 8, 2011, the EU had issued a new directive to lay down a community code relating to medicinal products for human use and to ensure that the defective products do not reach consumers, operational from July 2, 2013. The directive lays down a system of control over the entire supply chain for pharmaceuticals, which controls manufacture and import for marketing, wholesale and retail distribution.

However, with various EU industry members expressing their concern about the ability of India to comply with the new procedure by the deadline of July 2, India is optimistic that its pharma industry would be able to meet regulatory requirements within the given time frame. Further, as per the Ministry, in due course of time, online application filing and tracking system would be evolved to bring in sufficient expediency and transparency in the system.

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