The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has released procedures from the country’s Central Drug Standards Control Organization (CDSCO) for how Indian active pharmaceutical ingredient (API) manufacturers can obtain a written confirmation of quality that will be needed to ship their products to the EU.
Pharmexcil, which was set up by India’s Ministry of Commerce & Industry, explained that CDSCO is the body that will oversee the quality of APIs shipped to Europe.
The EU’s 2011 Falsified Medicines Directive (FMD) requires that, beginning in July, APIs cannot be imported into the EU unless accompanied by a written confirmation of GMP compliance from the authority in the third country that supervises the API manufacturers (IPQ “The News in Depth” May 31, 2011). In addition, the supervisory authority must establish GMPs and an inspection regimen that is deemed equivalent to those in the EU.
The CDSCO procedures released by Pharmexcil include: ● “Requirements for submission of application for issue of ‘Written Confirmation’ for active substances exported to the EU for medicinal products for human use, in accordance with Article 6(2)(b) of Directive No. 2001/83/EC ● “Procedure for Planning and Preparation of GMP Inspection for issue of ‘Written Confirmation’ for active substances exported to the EU,” and ● “Procedure for forwarding of non-compliances to EU.”