DRUGs AND COSMETICs

ACT 1940 AND RULES 1945

Presented by: Khushi Raza

B.Sc Sem V
Enrollment No: 2021-340-006
 HISTORY (NEED OF THE ACT)
• The modern medicines have been imported by India till after WW-I
which made India mostly dependent.
• In August 1930, Government under Chairman R.N Chopra appointed a
Drug Enquiry Committee for quality and standard of drugs sold and
recommendation for control measure.
• In 1939, Drug Import Bill was passed and placed for consideration.
• On 10th April 1940 bill was passed and became Drugs and Cosmetics
Act.
• In 1945, number of amendments have been done in Act.
Drug:
->All medicines for internal or external use of human beings or animals and
all substances intended to be used for or in diagnosis treatment or
prevention of any disease or disorder in human being.
->Substances other than food, intended to affect the structure of human
body.
Cosmetics:
Any article to be rubbed, sprinkled or sprayed onto part of human being for
cleansing, beautifying and promoting attractiveness.
 OBJECTIVES
To regulate the import, manufacture, distribution and sale of drugs
and cosmetics.
To regulate manufacture of drugs so that no substandard or spurious
drug get manufactured in India.
To regulate import of drug so that no substandard or spurious drug
get imported to India.
This act also provide for the control over sale and distribution of
drugs by only trained and qualified person.
This act also provides control over manufacture, distribution, sale f
AYUSH drugs.
 LIST OF AMENDING ACTS AND
ADAPTATION ORDERS
The Drugs (Amendment) Act, 1955
The Drugs (Amendment) Act, 1960
The Drugs (Amendment) Act, 1962
The Drugs and Cosmetics(Amendment)Act, 1964
The Drugs and Cosmetics (Amendment) Act, 1972
The Drugs and Cosmetics (Amendment) Act, 1982
The Drugs and Cosmetics (Amendment) Act, 1995
The Drugs and Cosmetics (Amendment) Act, 2008
The Drugs and Cosmetics (Amendment) Act, 2017
The Drugs and Cosmetics (Amendment) Act, 2018
The Drugs and Cosmetics (Amendment) Act, 2019
 CHAPTERS OF THE ACT
• Chapter I : Introduction And Definitions
• Chapter II : DTAB,DCC,CDL
• Chapter III : Import of Drugs And Cosmetics
• Chapter IV : Manufacture, sale and distribution of Drugs and
Cosmetics.
• Chapter IV A: Manufacture, sale and distribution of Ayurvedic, Siddha
and Unani Drugs
• Chapter V : Miscellaneous
 Schedules of Drug and Cosmetics Act
FIRST SCHEDULE: Lists of Ayurvedic, Siddha
and Unani Drugs
Ayurvedic Books:
Charak Samhita
Ayurveda Chintamani
Arya Bishak
Siddha Books:
Siddha Vaidya Thiratu
Nagmuni
Unani Books:
Al Karabadin
Karabadin Azam
Karabadin Quadri
• SECOND SCHEDULE
Deals with the standards to be compiled by the imported drugs and by
drugs manufactured for sale, sold and distribution.

Furthermore, schedules are subdivided in A-Z schedules.

 Different Administrative Bodies of Drug And
Cosmetic Act
ADVISORY
Drug Technical Advisory Board(DTAB)
• To advise the central and state
government on the technical
matters arising out of
administration of the act.
Drugs Consulative Committee(DCC)
• To advise the central and state
government and DTAB on any
matter so as to secure uniformity
in administration of act.
ANALYTICAL
Government Analyst
• To analyse or test the sample of
drugs or cosmetics sent by drug
inspectors and furnish the report
in the prescribed format.
Central Drug Laboratory(CDL)
• To analyse or analyse the sample
of drug or cosmetics sent to them
by the court or custom collectors.
Drug Control Laboratories
• Every state has lab for analysis and • Responsible for administering
testing of particular drug or
cosmetic manufactured or sold in
that particular area.
EXECUTIVE
Licensing Authorities
• Responsible for the issuance,
renewal or reinstatement of the
license.
Drug Inspectors
• To inspect, search, give order for
possession of drug or cosmetic
and to examine the documents
required to be maintained.
Custom Collectors
custom procedures and the
enforcement of trade laws and
regulations.
 Types of License Issued
• General Licence:
It is the license for retail sale of drugs and issued to the person
who has fixed premise for the business and engages the
services of qualified persons for sale.
• Restricted Licence:
It is the licence for the retail sale of drugs whose sale does not
require the supervision of qualified person.
• Loan Licence:
Licence issued by lincensing authority to person who does not
his own arrangements for manufacture but who intends to
avail of the facilities owned by another manufacturer.
• Repacking Licence:
It is the licence for repacking of drugs and granted for breaking
up any drug from bulk into small packages.
 IMPORT OF DRUGS
Prohibition of Import of Certain Drugs or Cosmetics:
1.Any drug or cosmetic which is not of standard quality;
2.Any misbranded or spurious or adulterated drug or cosmetics;
3.Any drug or cosmetic without an import license, for the import, for which an import license is
prescribed.
4.Any drug which claims to cure or prevent any disease or ailments specified in Schedule J.
5.Any cosmetic or drug-containing ingredient, which is unsafe or harmful.
6.Drugs not labeled in the prescribed manner.
Import of Drugs under License:
The following classes of drugs can be imported under the license or permit granted
by the licensing authority:
1. Drugs specified in schedules C and C1 excluding those specified in Schedule X.
2. Drugs specified in schedule X.
3. Minor quantities of drugs imported for the examination, test, or analysis.
4. Drugs for personal use are covered by a prescription of RMP.
Offenses and Penalties Regarding Import
of Drugs
 MANUFACTURE OF DRUGS
Prohibition of Manufacture and Sale of Certain Drugs:
The following drugs are prohibited to manufacture for sale under section 18 of
the act:
1.Any drug or cosmetic which is not of standard quality or is misbranded,
adulterated, or spurious.
2.Any patent or proprietary medicine, whose formula with the quantities, is
not disclosed on the label or container.
3.Any drug which purports or claims to prevent, cure or mitigate any such
disease specified in schedule J.
4.Any cosmetic containing any ingredient which may render it unsafe or
harmful for use.
GENERAL CONDITIONS FOR LABELLING OF DRUGS
AS PER DRUGS AND COSMETICS ACT,1940
Proper name of drug along with trade name (if any)
Statement of net contents in terms of weight, volume, number of units etc.
Quantity of active ingredients expressed in terms of amount per single
dose.
Name and Address of manufacturer.
Distinctive Batch Number
Manufacturing Licence Number: Mfg Lic. No.
Date of Manufacture
Date of Expiry
 DRUGS AND COSMETICS ACT, RULES
• RULE 151: Manufacturing on more than one set of premises.
• RULE 154: Form of Licence to manufacture AYUS drugs.
• RULE 154(A): Form of Loan Licence.
• RULE 155: Certificate of Renewal Of Licence.
• RULE155(A): Certificate of Renewal of Loan Licence
• RULE155(B): Certificate of award of GMP (Good Manufacturing Practices)
• RULE 159: Cancellation and Suspension of Licence.
• RULE 161: Labelling, packing and limit of alcohol on Ayurvedic and Unani Drug.
True list of all ingredients used in manufacture of preparation together.
• RULE 161 (B): Specify maximum shelf life or date of expiry.
• RULE 168: Standards to be compiled with manufacture, sale and distribution of AYUS drugs.
• RULE 169: Permissible excipients(antioxidants, preservatives) for manufacturing of AYUS drugs.
• RULE 170: To prohibit the advertisements of ASU drugs
 OFFENCES AND PENALTIES
• Penalty for the use of government analyst report for advertising
Fine upto Rs500/- on first conviction or imprisonment upto 10 years or
both.
• Penalty for nondisclosure of name of manufacturer
Fine upto Rs1000/- or imprisonment upto 1 year or both.
• Any spurious cosmetics, shall be punishable with fine or
imprisonment upto 3 years or both.