FDA approval of a drug means that data on the drug's effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.
The CDSCO also coordinates activities of several state drug control organisations and provides expert advice with a view to bringing about uniformity in the enforcement of the Drugs and Cosmetics Act. The CDSCO has the power to ban a drug that is considered harmful or sub-therapeutic under Section 26A of the act.