India’s Central Drugs Standard Control Organization (CDSCO) issued finalized guidelines for drugmakers to comply with the EU’s new directive on standards for import of APIs on 23 May 2013. The new EU rules take effect on 2 July 2013.

In order to comply with article 42b2(b) of the EU’s Falsified Medicines Directive 2001/83/EC India’s regulatory agency must provide written confirmation that APIs exported to the EU are manufactured in compliance with standards of GMP at least equivalent to those required in the EU.

On 18 June 2013, the list from the CDSCO included 57 different sites from both India-based manufacturers, such as Ranbaxy Laboratories, and Indian sites from global pharma companies, such as DSM.

The list is good news for the EU with respect to APIs sourced from India, however, China, another major API producer is still experiencing difficulties and needs ‘more work’ in order to comply with the new EU rules. In fact, China’s regulatory authority, the CFDA (formerly SFDA), has stated that it would not issue ‘written confirmation’ for manufacturing sites that are not under its supervision. EMA will therefore need to coordinate the inspections of the approximately 30 sites that this concerns [1]. On a positive note, the China Chamber of Commerce for Import & Export of Medicines & Health Products, which represents API manufacturers, has asked German audit firm Blue Inspection Body to help its members to comply with the EU GMP regulations.

Related articles

EU lists Japan as having equivalent GMP standards

Indian Government moves closer to complying with EU API rules

Reference

1.  GaBI Online - Generics and Biosimilars Initiative. China and India still to comply with new EU API rules [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jun 28]. Available from: www.gabionline.net/Policies-Legislation/China-and-India-still-to-comply-with-new-EU-API-rules

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