Central Drugs Standard Control
Organization
Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India

THIS  SITE PROVIDES GENERAL INFORMATION ABOUT DRUG REGULATORY REQUIREMENTS IN INDIA 

 

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About Us

Central Drugs Standard Control Organization   

State Drugs Control Organization

Organizational Chart  

Import of Drugs

Re-Registration Circulation letter 

Import of Drugs for Personal use 

Drugs for marketing in India

Imported Formulations  Registered  

Bulk Drugs Registered  

Vaccines Registered  

Critical Diagnostics & Blood Products

Global Clinical Trials  

Global Clinical Trials

Registration of Clinical Trials NEW!!

Manufacturing Units Having WHO GMP Certification   

Drugs

Approved for Marketing in India  

Permission to Market in India

Drugs Banned in India

Medical Devices and Diagnostics

Current Topics

 Training & Workshops

Information   

Spurious Drugs --- Reward Scheme for Whistle Blowers 

Oseltamivir phosphate (Tamiflu) DCC Minutes of Antimalarial drugs  

Guidelines for grant of License in Form-11

Documents to be submitted for Bioequivalence Study for export applications

Report on countrywide survey for Spurious Drugs NEW!!

Related Links

Vacancies NEW!!

OFFICE ORDER

Public Notice - medical device regulation  

Daily Despatch Details  

EXPORT OF CLINICAL TRIAL SAMPLES

Implementation of WHO certification Scheme by CDSCO  

 

Targeted Timelines for Approvals

 

Schedule X Licensed Shops in the country

 

Modalities for grant of

WHO-GMP Certificate of Pharmaceutical Product by CDSCO

 

NOTICE (Download Annexure Sheet) NEW!!

 

NOTICENEW!

 

Draft Guidance for Industry on Fixed Dose  CombinationsNEW!!

 

Guidance Document on Common Submission Format for Registration of Medical Devices in IndiaNEW!!

 

 

Requirements for Conducting Clinical Trial(s) of Medical Devices in IndiaNEW!!

Guidance document on application for grant of Licence in Form-28 for manufacture of Medical Devices in India under CLAA Scheme NEW!!

 

 

 

Rules & Regulation

Laws For Drugs & Cosmetics

Drugs & Cosmetic Act & Rules

The Drugs & Cosmetics (Amendment) Act, 2008 

and Guidelines

Gazette Notification G.S.R.304 (E) --

Draft Rules regarding Umbilical Cord Blood NEW!!

Gazette Notification regarding Import & Registration of Cosmetics NEW!!

Notification   

Right to Information Act , 2005

Central License Approving Authority

Blood Bank & its Products  

LVP, Vaccine & Sera

Guidance to applicants for LVP Manufacture

Other Topics

Goods Manufacturing Practices

Mashelkar Committee Report  

Consultation for Review of Guidelines

Checklist for Test Licenses/ Export NOC Applications

Neutral Code - labelling

Narcotic & Psychotropic

 Substance

National List of Essential Medicines

Good Clinical Practice

Pharmacovigilance

List of Diagnostic Kits for Blood Bank

Biologicals

Guidance For Industry

         Submission of Clinical Trial Application for Evaluating Safety and Efficacy

         Requirements for permission of Drugs Approval

         Post approval changes in biological products: Quality safety and Efficacy Documents

         Preparation of the Quality Information for Drug Submission for Drug Approval: Biotechnological/Biological Products

 

PRESCRIBING INFORMATION OF VACCINE FOR MEDICAL HEALTH PROFESSIONAL

 

Drugs Banned in India

 

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