Rohit Shishodia
The Drugs Controller General (India) Dr VG Somani has said that manufacturers and stakeholders may submit their applications by December 2, 2019, for regularization of FDCs declared as rational in respect of 294 FDCs by the Drug Testing Advisory Board.

This has been stated in a notice issued by Dr Somani after licenses for manufacturing and marketing of these FDCs were given by State Licensing Authority (SLA) without prior approval from DCG (I).

“It has been decided that manufacturers and stakeholders who are holding license for these FDCs from SLA may submit their applications by December 2, 2019. Further, all applicants are requested to submit their applications along with requisite fees as specified in the Sixth Schedule of the New Drugs and Clinical Trials Rules, 2019” reads the notice.