Introduction Drug Standards Drug laws Schedule

Drug Control,
Drug Standards and
Laws

Renjith R

Department of Pharmacology
Sree Gokulam Medical College & Research Foundation
Venjaramoodu, Trivandrum

Renjith R General Pharmacology

 Introduction Drug Standards Drug laws Schedule

Outline

1 Introduction

2 Drug Standards

3 Drug laws

4 Schedule

Renjith R General Pharmacology

 Introduction Drug Standards Drug laws Schedule

Introduction

Rational use of drugs

Profit/ Service
1940 The Drugs Bill
1941 DTAB

Renjith R General Pharmacology

 Introduction Drug Standards Drug laws Schedule

Grouping

Official drugs
Dangerous drugs
Prescription drugs
OTC drugs

Renjith R General Pharmacology

 Introduction Drug Standards Drug laws Schedule

Drug Standards
. . . Drugs & Cosmetic Act

Identity, Quality, Strength

IP, BP , USP, BPC, National formulary
Russian, French & Swiss

Renjith R General Pharmacology

 Introduction Drug Standards Drug laws Schedule

Drug Laws

Drug laws Year

The Opium Act 1878
The Poison Act 1919
The Dangerous Drugs Act 1930
The Drugs And Cosmetics Act 1940
The Pharmacy Act 1948
The Drugs And Magic Remedies Act 1954
The Medical And Toilet Preprations Act 1955
Prevention of Cruelty to Animals Act 1960
The Narcotic Drugs And Psychotropic Substance Act 1985
The Drug Order 1995

Renjith R General Pharmacology

 Introduction Drug Standards Drug laws Schedule

Shedules
Controlling Manufacture & distribution of Drugs

Shedule C, C1
Shedule E
Shedule F, F1
Shedule G
Shedule H
Shedule J
Shedule L
Shedule X
Shedule Y

Renjith R General Pharmacology

Introduction Drug Standards Drug laws Schedule

Renjith R General Pharmacology

 Introduction Drug Standards Drug laws Schedule

The Drugs and Cosmetics Act 1940

Regulate the import, manufacture, distribution and sale of

drugs.
Advisory agencies
Central Government appoints the Drugs Technical Advisory
Board
Constitute subcommittees
Analytical agencies
Excecutive agencies
Amendment 1962
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Renjith R General Pharmacology

 Introduction Drug Standards Drug laws Schedule

The Pharmacy Act 1948

Amended in 1959, 1976 and 1984.

Regulate the profession of Pharmacy in India
Central Pharmacy Council of India.
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Renjith R General Pharmacology

 Introduction Drug Standards Drug laws Schedule

The Drugs and Magic Remedies Act 1954

Objectionable Advertisements

Control the Advertisements regarding drugs

Punishable with imprisonment which may extend to six
months
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Renjith R General Pharmacology

 Introduction Drug Standards Drug laws Schedule

The Narcotic Drugs and Psychotropic Substances Act,

1985

Control and regulation of operations relating to Narcotic

Drugs and Psychotropic Substances
Enacted by repealing the Dangerous Drugs Act 1930 and the
Opium Act of 1878.
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Renjith R General Pharmacology