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B-PHARMA V-SEM CLASS

PHARMACEUTICAL
JURISPRUDENCE

BY
SMRITI PARASHAR

Drugs and Cosmetics Act, 1940 and its rules 1945 smriti parashar
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UNIT-I
Drugs and Cosmetics Act, 1940 and its rules 1945
1. Objectives, Definitions, Legal definitions of schedules to the Act and Rules
2. Schedules A to Y
3. Import of drugs
4. Manufacture of drugs

CHAPTER 1
Objectives, Definitions, Legal definitions of schedules to the Act and Rules

JURISPRUDENCE
The word jurisprudence derives from the Latin term juris prudential which means "the
study, knowledge or science of law.” In hindi न्यायशास्र. So Pharmaceutical
Jurisprudence means study of the laws for Pharmaceuticals given by Government of India.
This course is designed to impart basic knowledge on important legislations related to the
profession of pharmacy in India.

OBJECTIVE
The D&C Act was passed in 1940 (10th April 1940), with the main objectives:
1. Import
2. Manufacture
3. Distribution & Sale of drug & cosmetics
4. Labelling & packing of drugs & cosmetics
5. Administration of the act and rules
 The act regulates the import of drugs in India, so that no substandard or spurious
drug will enter into our country.
 The act prohibits the manufacture of substandard or spurious drug in the country.
 The act provide control over the sale & distribution of drugs by only trained &
qualified persons.

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 The act also provide control over the manufacture, sale & distribution of Ayurvedic,
Siddha, Unani & Homeopathic drugs.
 Certain provisions of the act regulate the import, manufacture, sale & distribution of
cosmetics.
 To have regular inspection of licensed premises by drug inspectors.
 To have control over the standards of drugs & cosmetics by taking samples &
analyzing them at approved laboratories.
 To provide special provisions to regulate the preparation, standardization & storage
of biological & special products.
 To prescribe the manner of labelling & packing of the various classes of drugs
& cosmetics.
 Administration of the act and rules: Drugs Technical Advisory Board, Central drugs
Laboratory, Drugs Consultative Committee, Government drug analysts, Licensing
authorities, controlling authorities, Drugs Inspectors.

DEFINITIONS
“Drug”
1. All medicines for internal or external use of human beings or animals and all substances
intended to be used for or in the diagnosis, treatment, mitigation or prevention of any
disease or disorder in human beings or animals, including preparations applied on
human body for the purpose of repelling insects like mosquitoes.
2. Such substances (other than food) intended to affect the structure or any function of the
human body or intended to be used for the destruction of [vermin] or insects which cause
disease in human beings or animals, as may be specified from time to time by the central
government by notification in the official gazette.
3. All substances intended for use as components of a drug including empty gelatin
capsules; and Such devices intended for internal or external use in the diagnosis,
treatment, mitigation or prevention of disease or disorder in human beings or animals, as
may be specified from time to time by the central government by notification in the official
gazette, after consultation with the board.

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“Ayurvedic, Siddha or Unani drug”

These includes all medicines intended for internal or external use for or in the diagnosis,
treatment, mitigation or prevention of [disease or disorder in human beings or animals,
and manufactured] exclusively in accordance with the formulae described in, the
authoritative books of [Ayurvedic, Siddha and Unani Tibb system of medicine],
specified in the First Schedule.

“Cosmetic”
Any article intended to be rubbed, poured, sprinkled or or sprayed on, or introduced into,
or otherwise applied to, the human body or any part thereof for cleansing,
beautifying, promoting attractiveness, or altering the appearance, and includes any article
intended for use as a component of cosmetic.

“The board”
In relation to [Ayurvedic, Siddha or Unani] drug, the [Ayurvedic, Siddha and Unani Drugs
Technical Advisory Board] constituted under section 33C.
and
In relation to any other drug or cosmetic, the Drugs Technical Advisory Board constituted
under section 5.

“Government analyst”
In relation to [Ayurvedic, Siddha or Unani] drug, a government analyst appointed by
the central government or a state government under section 33F.
and
In relation to any other drug or cosmetic, a government analyst appointed by the central
government or a state government under section 20.

“Inspector”
In relation to [Ayurvedic, Siddha or Unani] drug, an inspector appointed by the
central government or a state government under section 33G.
and
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In relation to any other drug or cosmetic, an inspector appointed by the central

government
or a state government under section 21.

“Manufacture”
In relation to any drug [or cosmetic] includes any process or part of a process for making,
altering, ornamenting, finishing, packing, labeling, breaking up or otherwise treating
or adopting any drug [or cosmetic] with a view to its [sale or distribution] but does not
include the compounding or dispensing [of any drug, or the packing of any drug or
cosmetic,] in the ordinary course of retail business; and “to manufacture” shall be
construed accordingly.

“Patent or proprietary medicine”

In relation to Ayurvedic, Siddha or Unani Tibb systems of medicine all formulations
containing only such ingredients mentioned in the formulae described in the authoritative
books of Ayurvedic, Siddha or Unani Tibb systems of medicine specified in the First
Schedule, but does not include a medicine which is administered by parenteral route
and also a formulation included in the authoritative books as specified in clause (a).
and
In relation to any other systems of medicine, a drug which is a remedy or
prescription presented in a form ready for internal or external administration of human
beings or animals and which is not included in the edition of the Indian Pharmacopoeia for
the time being or any other Pharmacopoeia authorised in this behalf by the Central
Government after consultation with the Drugs Technical Adivisory Board constituted
under section 5.

“To import”
With its grammatical variations and cognate expressions means to bring into [India].

“Prescribed” means prescribed by rules made under this Act.

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SCHEDULES TO THE ACT AND RULES

Schedules to Drugs & Cosmetics Act 1940

1. First schedule
Names of books of Ayurvedic, Siddha and Unani systems.
Ayurvedic system books like Arogya Kalpadruma, Arka Prakasha, etc.
Siddha systems books like VaidyaThirattu, Therayar Maha Karisal, etc.
Unani system books like KarabadinQadri, Karabadin Kabir, etc.

2. Second schedule
Various Standards to be Complied with by Imported Drugs and by Drugs Manufactured for
Sale, Sold, Stocked or Exhibited for Sale or Distributed.

Schedules to Drugs & Cosmetics Rules, 1945

The Drugs and Cosmetics Rules, 1945 is an Act of the Parliament of India which contains
provisions for classification of drugs under given schedules and there are guidelines for the
storage, sale, display and prescription of each schedule. There are 168 Rules & 25 Schedule
from A to Y in d & c rules, 1945.

Drugs and Cosmetics Act, 1940 and its rules 1945 smriti parashar