Indian API manufacturers get CDSCO nod to supply to local R&D

Indian companies can supply active pharmaceutical ingredients (APIs) to local research and development companies and institutes, the country's Central Drugs Standard Control Organization (CDSCO) said. In a March 25 notice, CDSCO said manufacturers need to obtain what is called a "No Objection Certificate" to supply APIs used in development and production of trial batches of drugs that are intended for export. Previously, local formulators of trial batches for export were required to import the APIs. Further, CDSCO said companies that supply local formulators must label the APIs for test and analysis only. Notice (PDF)