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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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
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
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!
Office order regarding Medical Device Draft Guidance NEW!
Guidance Document on Common Submission Format for Import Licence in Form 10 of Medical Devices in IndiaNEW!!
Draft Guidance for Industry on Fixed Dose CombinationsNEW!!
Guidance Document on Common Submission Format for Registration of Medical Devices in India NEW!!
Requirements for Conducting Clinical Trial(s) of Medical Devices in India NEW!!
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
Clarification & Amendments in guidance for industry with respect to Post Approval Changes in Biologicals ProductsNEW!!
PRESCRIBING INFORMATION OF VACCINE FOR MEDICAL HEALTH PROFESSIONAL
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