Basic information for beginners...

1. Drug Regulatory Systems in IndiaBy,CHANDRAMOHAN

2. • Introduction
• Organizational Structure
• Drug Approval Process in India
• Differences between US, EU and India
• D&C Act, 1940 – D&C Rules, 1945
• Types of licenses

3. Introduction
• In India drugs are regulated both at central and state level.
• At the central level CDSCO (Central Drugs Standard Control Organization) under
the ministry of Health and Family Welfare is responsible for approving new drugs,
clinical trials and licensing of drugs.
• At the state level state drug regulatory authorities issues licences to manufacture
approved drugs to monitor the quality of the drugs along with CDSCO.
• In India the regulation of drug, medical devices, and biological and r-DNA
products is distributed within various ministries.

4. Organizational Structure
The Central Drug Standard Control Organization (CDSCO) is the key authority for new drug approvals in
India, which is headed by the Drug Controller General of India (DCGI), and CDSCO is responsible for drug
approval, overseeing clinical trials, good manufacturing practice (GMP) monitoring, and other related
functions as specified by the central government. The CDSCO is a subordinate office of the Director General
of Health Services (DGHS) in the Ministry of Health and Family Welfare (MHFW).

5. Main bodies
• Central Drug Standard Control Organization (CDSCO)
• Ministry of Health & Family Welfare (MHFW)
• Indian Council of Medical Research (ICMR)
• Indian Pharmaceutical Association (IPA)
• Drug Technical Advisory Board (DTAB)
• Central Drug Testing Laboratory (CDTL)
• Indian Pharmacopoeia Commission (IPC)
• National Pharmaceutical Pricing Authority (NPPA)

7. Drug approval process in INDIA
1. Form 44.
2. Treasury Challan of INR 15,000 if all the active ingredients are approved in
India for more than one year, or INR 50,000 in case any of the active ingredients
is approved for less than one year.
3. Source of bulk drugs /raw materials: For those ingredients which are approved
and considered new drugs - If the applicant has a manufacturing license for bulk
drugs, a copy of the same is needs to be submitted. Otherwise, provide the
consent letter from the approved source regarding supply of material.

12. D&C Act, 1940–D&C Rules, 1945
• Changes to regulate the import, manufacture, sale or distribution Drugs &
Cosmetics for assuring their Quality, Safety and Efficacy
• Regulate through a system of Licensing/Issuing permits
• The Act has 6 Chapters
• Rules has 19 parts

13. Scheme of the D&C Act
THE ACT - SIX CHAPTERS
1. Chapter I - Preliminaries & Definitions
2. Chapter II - CDL, DCC, DTAB
3. Chapter III - Import of Drugs & cosmetics
4. Chapter IV - Manufacture and Sale of Drugs & Cosmetics
5. Chapter IVA - Ayurvedic Drugs
6. Chapter V - Miscellaneous

14. Schedules
• SCHEDULE A – Forms
• SCHEDULE B – Fee for Test or Analysis
• SCHEDULE C – Biological & Special Products
• SCHEDULE C1 – Other Special Products
• SCHEDULE D – Exemptions u. c. III
• SCHEDULE D(1) – Information – Product Registration for import

15. Schedules
• SCHEDULE D(II) – Details for Import
• SCHEDULE F(I) – Bacterial Vaccines, Sera
• SCHEDULE FF – Standards Ophthalmic preparations
• SCHEDULE G – Drugs to be used under the supervision of RMPs
• SCHEDULE H – Prescription Drugs

16. Schedules
• SCHEDULE J – Prohibition on advertisements on drugs
• SCHEDULE M – Good Mfg Practices
• SCHEDULE N – Pharmacy- requirements
• SCHEDULE P – Life Period of drugs
• SCHEDULE P 1 – Pack size of drugs
• SCHEDULE U – Records – Drugs
• SCHEDULE Y – Requirements and Guide lines for permission to
import and/or manufacture of New Drugs for sale or
undertake Clinical Trials

17. Types of Licenses
Manufacture for sale
Manufacture for test, examination or analysis
Sale of Drugs – Whole sale, Retail, Restricted
Import of Drugs

18. Forms for Licenses
Manufacturing Unit (Other than those specified in C, C1 & X):
Application – Form 24
License – Form 25
Loan License (Other than those specified in C, C1 & X):
Application – Form 24 A
License – Form 25 A
Repacking (Other than those specified in C, C1 & X):
Application – Form 24 B
License – Form 25 B

19. Forms for Licenses
Manufacturing Unit (Schedule X):
Application – Form 24 F
License – Form 25 F
Manufacturing Unit (Schedule C & C1):
Application – Form 27
License – Form 28
Loan License (Schedule C & C1):
Application – Form 27 A
License – Form 28 A

20. Import Licenses

21. Import Licenses