2. MONIKA KAURAV
ASSISTANT PROFESSOR
KIET SCHOOL OF PHARMACY
KIET GROUP OF INSTITUTIONS
DELHI NCR GHAZIABAD
DRUGS AND COSMETICS
ACT,1940AND ITS RULES
1945
(HISTORY, OBJECTIVES&
LEGAL DEFINITIONS)
3. The word jurisprudence derives from the Latin term juris prudentia, which
means "the study, knowledge, or science of law." Jurisprudence commonly
means the philosophy of law
. The third type of jurisprudence seeks to reveal
the historical, moral, and cultural basis of a particular legal concept.
Pharmaceutical jurisprudence is the study of laws regulating the profession
of pharmacy in India. It includes all the acts and rules thereof mentioned in the
constitution of India. E.g. drug and Cosmetics act and rules, pharmacy act, MTP
act, magic remedies act, etc.
5. British misrule-Providing poor healthcare system to Indian citizens
Observations made by-Drugs Enquiry Committee, Indian Medical
Association
Reports in- Indian Medical Gazette during 1920-30
1940 – Drugs and Cosmetics Act
1945 – Rules under the Act
Extended to whole ofIndia……
HISTORY
6. HISTORY
The Parliament of India formed an Act which regulates the import,
manufacture and distribution of drugs in India
The primary objective of the Act is to ensure that the drugs and cosmetics
sold in India are safe, effective and conform to prescribed quality
standards
The Drugs Act was formulated in 1940 in pursuance of recommendations of
Chopra Committee constituted in 1930 by Government of India
The drugs under the Drugs and Cosmetic Act cover wide varieties of
therapeutic substances, diagnostics and medical devices
7. HISTORY
The Act has been further amended as Drugs (amendment) Act 1964 to
include Ayurvedic and Unani drugs
The Drugs Act, as enacted in1940, has since been amended several
times and is now titled as “The Drugs and Cosmetics Act, 1940”.
8. HISTORY
The drug rules were promulgated in December 1945 and enforcement of
these rules started in 1947
The Rules have also been amended time to time to meet the needs of the time
and to rectify any deficiencies noticed during the implementation
The responsibility of enforcing the various Acts vests with the Central
government and State/Union Territory (UT) governments
Under the Drugs and Cosmetics Act, the drugs are classified in schedules
and regulations are laid down for their storage, display, sale, dispensing,
leveling, prescribing etc.
9. OBJECTIVES
To regulate the import, manufacture, distribution and sale of drugs
and cosmetics through licensing.
manufacture distribution and sale of drugs and cosmetics by qualified persons
only
To prevent sub standard in drugs for maintaining high standards of medical
treatment.
To regulate the manufacture and sale of Ayurvedic, Siddha and Unani drugs
To establish Drugs Technical Advisory Board and Drugs
Consultative Committee for allopathic and allied drugs and cosmetics.
10. The salient features of the Drugs &Cosmetics Act, 1940 are
as follows:
Maximum penalty life imprisonment and fine of Rs. 10 lakhs or 3 times
the value of the confiscated goods, whichever is more.
Some of the offences cognizable and non-bailable.
Besides officers from the Drug Controller’s Office, other gazette officers
also authorized to launch prosecution under the Act;
Specially designated courts for trial of offences covered under the Act;
Provision for compounding of minor offences.
11. ABBREVIATIONS
• Adaptation of Laws Order,1950
• Clause
• Inserted
• Page
• Part
• Regulation
• Repealed
• Section
• Schedule
• Section
• Substituted
• with effectfrom
A.O.1950
Cl.
Ins.
P
.
Pt.
Reg.
Rep.
S.
Sch.
Sec.
Subs.
w.e.f.
12. PART 1 :DRUG AND COSMETIC ACT,1940
Chapter 1 • Introductory
Chapter 2
• The drugs TechnicalAdvisory Board,The
Central Drug Laboratory, The Drugs
Consultative Committee
Chapter 3 • Import of Drugs and Cosmetics
Chapter 4
• Manufacturing ,Sales and Distribution of Drugs
and Cosmetics
Chapter 4A
• Provisions relating to Ayurvedic ,Siddha and
Unani Drugs
Chapter 5 • Miscellaneous
13. PART 2 :DRUG AND COSMETIC RULES,1945
Part1 • Preliminary
Part2 • The Central Drugs Laboratory
Part3 • Rules 9to 20
Part4 • Import and Registration
Part5
• Government Analysts,Inspectors,Licensing
Authorities andcontrolling authorities
Part6 • Sale of Drugs other than Homeopathic
Medicines
Part6A • Sale of Homeopathic Medicines
Part7 • Manufacture for sale or for distribution of
Drugs other than Homeopathic Medicines
14. PART 2 :DRUG AND COSMETIC RULES,1945
Part 8
Part9 • Labelling and Packing of Drugs Other Than
Homeopathic Medicines
Part10
• Special Provisions Relating to Biological and
Other Special Products
Part10A
• Import of Manufacture of New Drug for Clinical
Trials or Marketing
Part10B
• Requirements for the collection , storage ,
processing and distribution of whole Human
Blood, Human Blood Components by Blood
Banks and Manufacture of Blood Products
• M anufacture for Examination, T
est or
Analysis
15. PART 2 :DRUG AND COSMETIC RULES,1945
Part 11
Part 12
Part 13
Part14
• Manufacture of Cosmetic for Sale or For
Distribution
Part15 • Labelling,Packing and Standards of Cosmtics
Part16
• Manufacture for sale of ayurvedic (including
Siddha) or Unani Drugs
• Exemptions
• Standards
• Import ofcosmetics
16. PART 2 :DRUG AND COSMETIC RULES,1945
Part17 • Labelling,Packing, Limit of Alcohol in
Ayurvedic (Including Siddha) or Unani Drugs
Part18 • Government Analysts and Inspectors for
Ayurvedic (Including Siddha) or Unani Drugs
Part19 • Standards of Ayurvedic ,Siddha and Unani
Drugs
17. PRESCRIBED APPENDICES
Appendix 1
• Data required to be submitted with application for the permission to
market a newdrug.
Appendix 2
• Format for submission of clinical trial reports.
Appendix 3
• Animal toxicity requirement for clinical trials and marketing of a new drug.
Appendix 4
• Number of animals for long term toxicity studies
Appendix 5
• Patients consent form for participating in a Phase I clinical trial
Appendix 6
• Four groups of fixed dose combination and their data requirement
18. The Drug and Cosmetics act, 1940 was enacted by the Department of Health
under the Ministry of Health and Family Welfare after receiving the assent of the
Governor General on April 10, 1940 and came into force on April 1, 1947
FIRST SCHEDULE:
list of ayurvedic, siddha and unani books.
SECOND SCHEDULE:
standards to be compiled with by imported drugs and by
drugs manufactured for sale, sold, stocked or exhibited for
sale or distributed.
It contains 168 rules from 1 to 168 and 25 Schedules from Schedule
A to ScheduleY.
19. LEGAL DEFINITIONS
Drug includes :
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
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
20. LEGAL DEFINITIONS
Drug includes :
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
21. LEGAL DEFINITIONS
Cosmetic includes :
Any article intended to be rubbed, poured, sprinkled or sprayed on, 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.
22. Misbranded drugs :
if it is so colored, coated, powdered or polished that damage is
concealed
if it is not labelled in the prescribed manner; or
if its label or container or anything accompanying the drug bears any
statement, design or device which makes any false claim for the drug or
which is false or misleading in any particular.
LEGAL DEFINITIONS
23. Adulterated drug :
if it consists, in whole or in part, of any filthy, putrid or decomposed
substance;
or
if it has been prepared, packed or stored under insanitary conditions whereby
it may have been contaminated with filth or whereby it may have been
rendered injurious to health; or
if its container is composed in whole or in part, of any poisonous or
deleterious substance which may render the contents injurious to health.
LEGAL DEFINITIONS
24. Spurious drugs :
if it is imported under a name that belongs to another drug; or
if it is an imitation of, or a substitute for, another drug or
resembles another drug in a manner likely to deceive or bears
upon it or upon its label or container the name of another drug,
or
if it has been substituted wholly or in part by another drug or
substance.
LEGAL DEFINITIONS
25. LEGAL DEFINITIONS
Patent or Proprietary Medicine means :
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 Ayurveda, 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);
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 authorized in this behalf by the Central Government
after consultation with the Drugs Technical Advisory Board constituted under section 5
26. LEGAL DEFINITIONS
Registered Medical Practitioner means a person :
holding a qualification granted by an authority specified or notified under Section 3 of the Indian
Medical Degrees Act, 1916, or specified in the Schedules to the Indian Medical Council Act,
1956;or
registered or eligible for registration in a medical register of a State meant for the registration of
persons practicing the modern scientific system of medicine [excluding the Homoeopathic
system of medicine];or
registered in a medical register other than a register for the registration of Homoeopathic
practitioners of a State, who although not falling within sub- clause (i) or sub-clause (ii) is
declared by a general or special order made by the State Government in this behalf as a person
practicing the modern scientific system of medicine for the purposes of this Act ;or
registered or eligible for registration in the register of dentists for a State under the Dentists Act,
1948;or
who is engaged in the practice of veterinarymedicine and who possesses qualifications
approved by the State Government
27. LEGAL DEFINITIONS
HOMOEOPATHIC MEDICINES
It includes any drug whose therapeutic efficacy has been established through
long clinical experience as recorded in authoritative Homeopathic literature,
prepared according to the techniques of Homeopathic pharmacy. It does not
include medicines, administered by the parenteral route.
Registered Homoeopathic medical practitioner meansa
person who is registered in the Central Register or a State Register of
Homoeopathy
28. LEGAL DEFINITIONS
Ayurvedic, Siddha Or Unani Drugs 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 systems of
medicine], specified in the First Schedule.
Manufacture in relation to any drug or cosmetic includes : any process or part
of a process for making, altering, ornamenting, finishing, packing, labelling,
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
29. LEGAL DEFINITIONS
Government Analyst means :
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 means :
in relation to Ayurvedic, Siddha or Unani drug, an Inspector appointed by the Central Government
or a State Government under section 33G; and
in relation to any other drug or cosmetic, an Inspector appointed by the Central
Government or a State Government under section 21
30. LEGAL DEFINITIONS
Central Licence Approving Authority means the Drugs Controller of India,
or the Joint Drugs Controller (India) or the Deputy Drugs Controller
(India) appointed by the Central Government
Director means the Director of the Central Drugs Laboratory
Form means a form set forth in Schedule A
Laboratory means the Central Drugs Laboratory
31. LEGAL DEFINITIONS
Retail Sale means a sale other than a sale by way of wholesale
dealing; whether to a hospital, or a dispensary, or a medical,
educational or research institute or to any other person
Sale by way of wholesale dealing means sale to a person for the
purpose of selling again and includes sale to a hospital, dispensary,
medical, educational or research institution
Poisonous Substance means a substance specified in Schedule E
32. SCHEDULE/ GUIDELINES RULE
A : Forms and formats of letters for applications of licensing etc.
B : Fee structure for drug analysis by CDL (Central Drug Laboratory) or by
the Govt. Analyst
C : Biological and special products for parenteral administration. Examples: Antibiotics,
Vitamins, Bacteriophages, Surgical dressings and Opthalmic preparations whose import,
manufacture, sale and distribution are governed by special provisions.
C(I) : Other special products for non-parenteral administration. Examples: Digitalis drugs,
Ergot drugs, Adrenaline, Fish liver oil, Hormonal preparations whose import, manufacture,
sale and distribution are governed by special provisions.
33. SCHEDULE/ GUIDELINES RULE
D : Exemptions that have been granted to drugs and importers of drugs from complying with
the requirements of import of the drugs and also the condition for such exemptions.
E(I) : List of poisonous substance under Ayurvedic, Siddha and Unani system of medicine
F and F(I): Special provisions applicable for the production, testing, storage,
packing and labelling of biological and other special products.
F(II):Standards of surgical dressings.
F(III):Standards of sterilized umbilical tapes.
FF: Standards for ophthalmic preparations.
34. SCHEDULE/ GUIDELINES RULE
G : List of substances that are required to be used under only medical supervision
and which are to be labelled accordingly. Ex. Metformin, Anti Histaminic, …etc
H : List of prescribed drugs that should be sold by retail only on prescriptionsof
R.M.P. Ex. Atenolol, Lorazepam, Dapson etc.
J : Disease or ailments which a drug may not purport to prevent or cure Ex.
Cancer, AIDS, Cataract, Diabetes…etc
K : Drugs exempted from certain provisions relating to the manufacture ofthe
drugs.
35. SCHEDULE/ GUIDELINES RULE
M : Good manufacturing practice (GMP) requirements of factory premises, plants
and equipments
M(I) : Requirements of factory premises for manufacturing of homeopathic
preparation.
M(II) : Requirements of factory premises for manufacturing of cosmetics.
M(III) : Requirements of factory premises for manufacturing of medical
devices
36. SCHEDULE/ GUIDELINES RULE
N : List of minimum equipments for efficient running of a pharmacy.
O : Standard for disinfectant fluids. Ex… Phenol, H2O2, alcohol etc
P : Life period of the drugs. Ex. Insulin Inj. – 24 months
P(I) : Pack size of the drugs
37. SCHEDULE/ GUIDELINES RULE
Q
Part-I : List of coaltar colours, dyes and pigments permitted in cosmetics and
soaps.
Part-II : List of colours permitted in soaps
Ex. Caramel, TiO2, Toney red
R : Standards for condoms which are made up of rubber latex intended for
single use and other mechanical contraceptives.
R(I) : Standards for medical devices
S : Various cosmetics and toiletries, and directs the
manufacturers of cosmetics to confirm to the latest
BSI (Bureau of Indian Standards) requirements.
38. SCHEDULE/ GUIDELINES RULE
• T : Requirement of factory premises and hygienic condition for Ayurvedic
(including Siddha) and Unani drugs.
• U : Particulars to be shown in manufacturing, raw material and analytical record of
thedrugs
• U(I) : Particulars to be shown in manufacturing, raw material and analytical record of
the cosmetics
• V : Standard for patent or proprietary medicines
39. SCHEDULE/ GUIDELINES RULE
W : List of drugs which can be marketed under generic names only.
X : Names of narcotic and psychotropic drugs for which special
control measure have been laid down
Y : Requirements and guidelines on clinical trials for import and
manufacture of the new drugs
