health · In Force

Drugs and Cosmetics Act 1940

Regulates import, manufacture, distribution of drugs/cosmetics. Schedule H/H1/X drugs require prescription. CDSCO central authority. GMP compliance. New Drugs & CT Rules 2019.

Amended

Multiple

Ministry

Ministry of Health & Family Welfare

Key provisions and changes

• Schedule H1 drugs (2013)
• CDSCO as central authority
• New Drugs & CTs Rules 2019
• Medical devices classified
• Clinical trial regulations