Regulatory Focus™ > News Articles > India issues revised draft guidance for API exports to EU

India issues revised draft guidance for API exports to EU

Posted 13 March 2013 | By Louise Zornoza

On 7 March 2013, India's Central Drugs Standard Control Organization (CDSCO) issued revised draft guidance on the "Written Confirmation" procedure that must be implemented by India's exporters of Active Pharmaceutical Ingredients (API) to the European Union.

The procedure will also be required to be implemented by the CDSCO, including its port offices. Under EU law, the CDSCO has been designated as the "Competent Authority" for India and is responsible for notifying the EU "immediately" of any non-compliance with GMPs. 

The preface to the revised draft explains that the EU has informed India that it will recognize two standards for compliance:

  • the World Health Organization's (WHO) Good Manufacturing Practices (GMP) document for active pharmaceutical ingredients, Annex 2- WHO Technical report Series (TRS), No. 957, 2010
  • the Interional Conference on Harmonisation's (ICH) Harmonized Triplicate Guideline (ICH Q9), the Good Manufacturing Practice guide for Active Pharmaceutical Ingredients. 

Comments on the revised draft must be submitted by 14 March 2013. 

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