Earlier this week the Indian regulator published the list of the active pharmaceutical ingredient (API) manufacturers it has issued with the “written confirmations” which, from July 2, must accompany all drug ingredient batches shipped to the European Union (EU).
The document includes 40 or so manufacturers - both Indian firms like Aurobindo, Divi’s Laboratories, Dr Reddy’s, Lupin and Ranbaxy and the local operations of global companies like Teva, DSM and Mylan - alongside copies of confirmation documents for each API.
The publication is one of a number of measures Indian authorities have taken to try and make sure APIs shipped to the EU comply with the new rules. In February, for example, the Central Drugs Standards Control Council (CDSCO) published a list of draft guidelines for manufacturers.
These efforts were acknowledged by a European Commission spokeswoman who told in-Pharmatechnologist.com that: “Much has been done, much remains to be done, but the signals are certainly encouraging.
“We welcome the initiative taken by the CDSCO to publish on its official website the list of the written confirmations they have issued as well as the scanned copies, since this facilitates compliance checks by EU Member State authorities.”
API makers in India and China make 80% of the drug ingredients used in Europe, which is a subject of concern for EU-based drugmakers and regulators worried that established supply lines would be cut when the new import laws come into effect next month.
The CDSCO publication follows just a day after a Beijing, China based group representing drug ingredient manufacturers – the China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE) – announced it had asked German audit form blue inspection body to help its members prepare for the EU import laws.
Speaking to this publication blue inspection body managing director Stefan Kettelhoit said that certain Chinese API suppliers – those that have not been inspected by the C-FDA (formerly the SFDA) or EU authorities - will not be issued with written confirmations.