Govt of India sets New Standards for Export of Medicines to EU to Comply EU's Updated Standards

The Indian Government has issued New Standards for exporting the drugs to European Union (EU). The change in the standards came after the EU issued new standards for importing drugs into it in 2011. These New standards of EU will be operational from July 2, 2013. So Government of India introduced the new procedural requirements of the European Union (EU) for import of Active Pharmaceutical Ingredients (APIs) into the EU.

"APIs are commonly referred to as bulk drugs in the pharmaceutical industry and are used in the making of formulations (medicines)."

The new legislation coming into force from 02.07.2013 requires a ‘written confirmation’ by a competent authority nominated by the Government of India that the API has been manufactured in accordance with EU-GMP standards and that 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.

The Department of Health & Family Welfare officially declared the Central Drugs Standard Control Organization (CDSCO) on 12.11.2012 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 the CDSCO which was also done.

Salient features of the guidelines laid down by the CDSCO:

1. Application for issue of “written confirmation” for APIs for medicinal products for human use is to be made by the exporter in prescribed format.
2. After satisfying the completeness of documents submitted, inspection shall be conducted and after satisfactory outcome thereof, formal written confirmation shall be issued.
3. Non-compliances noticed after inspection shall be communicated to the EU as per their requirement.
4. A time frame of 45 days has been prescribed for disposal of satisfactory applications and the written confirmation shall be valid for the three years.
5. Detailed forms have been laid down for purposes prescribed under various Articles of the EU Directives by the CDSCO – running into nearly 70 pages.
6. A online application filing and tracking system would be made available to bring in sufficient expediency and transparency in the system

As many members of the EU are raising concerns about India's ability to comply the new standards by 2nd July, but India is optimistic and almost sure that it is ready to do it by specified date.