What is a New Drug as per Drug and Cosmetic Rules (D&C)?
As per Rule 122 E of the Drug and Cosmetic Rules 1945, a New Drug can be – [1]
- A drug, including bulk drug substance which has not been used in the country and has not been recognized as effective and safe by the licensing authority for the proposed claims.
- An approved drug with modified or new claims like –
- New Indications
- New Dosage
- New Dosage Form (including sustained release dosage form)
- New Route of Administration