Complete Guide to CDSCO Approvals

About the Book

Navigating India’s CDSCO regulatory framework can be complex due to multiple laws, forms, digital portals and frequent regulatory updates. This book is designed to simplify the entire approval ecosystem for drugs, cosmetics and medical devices in India.

Complete Guide to CDSCO Approvals: Drugs, Cosmetics & Medical Device Registrations is a practical, structured and industry-oriented handbook that explains CDSCO registrations, licenses and compliance requirements in a clear and actionable manner.

The book covers end-to-end regulatory pathways, including documentation, procedures, timelines, government fees and common pitfalls. Special focus is given to CDSCO digital portals such as SUGAM, Medical Device Portal, ONDLS and NSWS for real-world application.

A key highlight of this guide is the CDSCO & State FDA Directory, making it a ready reference for regulatory professionals and businesses.

What This Book Covers

• Role, structure & authority of CDSCO
• Drugs & Cosmetics Act, 1940 and MDR 2017
• CDSCO digital portals – SUGAM, MD Portal, ONDLS & NSWS
• Drug Import Registration Certificate (Form 41)
• Drug Import License (Form 10)
• Drug manufacturing, loan & test licenses
• New drug approvals & special permissions
• Medical device classification (Class A–D)
• Medical device manufacturing, import & test licenses (MD forms)
• Software as a Medical Device (SaMD)
• Clinical trials & CRO registrations
• Cosmetics import, manufacturing & loan licenses
• CDSCO laboratory & ethics committee registrations
• Market Standing Certificate & Free Sale Certificate
• Practical case studies & international perspective
• CDSCO & State FDA directory

Who Should Read This Book

• Pharmaceutical manufacturers & importers
• Medical device & IVD companies
• Cosmetics manufacturers & brand owners
• Regulatory affairs & compliance professionals
• Healthcare startups
• Students pursuing regulatory careers
• Healthcare legal & regulatory consultants

Why Buy This Book

• Simplifies complex CDSCO regulations
• Reduces approval delays & compliance risks
• Provides step-by-step regulatory clarity
• Acts as a ready reference & compliance manual
• Supports confident and compliant India market access

Book Details

Title: Complete Guide to CDSCO Approvals: Drugs, Cosmetics & Medical Device Registrations
Authors: Rajul Jain & Shruti Jain
Organization: ELT Corporate Pvt. Ltd.
Category: Healthcare Regulatory | CDSCO | Drugs & Cosmetics | Medical Devices | MDR 2017