After more than a year delay, IPEC India is expected to be created by the end of the year after IPEC-Americas’ vice chair confirmed that the registration process is moving forward.
IPEC (International Pharmaceutical Excipients Council) India delayed its formation because of difficulties concerning the naming of the organization. The council was originally slated to launch in June 2012 .
“Key point people have been identified to run the initial association and it is hoped that planning can soon begin for an Excipient Control Strategies Conference in the first quarter of next year,” IPEC-Americas said.
The conference will provide a way to begin discussions on using IPEC Guides throughout India by makers, users, distributors and regulators for controlling the manufacture, distribution and use of excipients in drug products globally, the council said. The fees for such member companies in India are expected to be fair, David Schoneker, IPEC-Americas vice chair previously told us .
Schoneker recently visited India to meet with key industry representatives to discuss the formation of IPEC India. Schoneker also provided an update to Indian generic drug companies on IPEC-Americas’ efforts to work with the US FDA’s Office of Generic Drugs to improve the processes of the agency’s inactive ingredient database, especially in terms of how excipient families of similar grades are handled.
He also shared information concerning IPEC-Americas and the coalition’s activities related to ICH Q3D and USP <232>/<233> Elemental Impurities requirements, which were delayed earlier this summer in anticipation of the ICH guidance.
Schoneker told us earlier this summer that IPEC has worked with the FDA and industry to resolve concerns over how the requirements will be implemented and how companies can comply.
The appropriate papers for the Indian industry association are expected to be filed soon and it is anticipated that the registration process can be completed within six to eight weeks after these papers are submitted.