17/18 September 2019
The "Central Drugs Standard Control Organization" of India's Ministry of Health and Family Welfare has published on its website a list of Written Confirmations for manufacturers who export APIs to the EU. The page lists the sites including postal address, the names of APIs manufactured at the site concerned as well as the dates of issue and validity of the Written Confirmation. Moreover, you can click on the linked Written Confirmation number to open the respective scanned copy. The Written Confirmations are consecutively numbered.
Currently, there are 215 Written Confirmations in the list which is being constantly updated.
By the way, according the Q&A document of the EU Commission the use of one of these Written Confirmations is accepted. The answer to the corresponding question (No 18 in the Q&A document) is basically: yes, a copy may be used as long as the original is still valid (see our GMP News from 24 April 2013).
The CDSCO website also provided an access to the "Indian GMPs" in a document entitled "Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products".
Do you have any questions, comments or suggestions regarding the "import of API into the EU" and "Written Confirmations"? Send us an e-mail to firstname.lastname@example.org.