Regulation | USA | India |
Agency | FDA | CDSCO |
Regulation | Food, Drug and Cosmetic Act | Drugs and Cosmetic Act |
Pre-Market Approval | Not Required | Required from state authorities |
Safety | Responsibility of manufacturer | Manufacturer is asked to maintain records and furnish valid COAs and INCIs. |
Labelling Declaration | FDA 21 CFR 701 & 740 | According to BIS, FSSAI, AYUSH as applicable |
Label Language | English | English |