New Drugs Division

• Twelve New Drug Advisory Committees (NDAC)
• Approved for Marketing in India
• Permission to Market in India
• Guidelines on Common Technical Document (CTD) (New Drug Application -NDA
• System of preliminary scrutiny by C.D.S.C.O at the time of receipt of application for approval of Fixed Dose Combinations
• Draft Guidance for Industry on Fixed Dose  Combinations
• Clarification with respect of the manufacturing and marketing of New Drugs - regarding ^NEW
• ^{Draft Guidelines For Industry on Reporting Serious Adverse Events occurring in Clinical Trials}

• DRAFT GUIDANCE ON APPROVAL OF CLINICAL TRIALS & NEW DRUGS

• DRAFT GUIDANCE FOR INDUSTRY ON REQUIREMENT OF CHEMICAL & PHARMACEUTICAL INFORMATION INCLUDING STABILITY STUDY DATA BEFORE APPROVAL OF CLINICAL TRIALS / BE STUDIES