DRUG AND COSMETIC

ACT
 INTRODUCTION
• In British India, in 1937 a Bill was introduced in the Central
Legislative Assembly for recommendations of the Drugs
Enquiry Committee.
• To regulate the import, manufacture, distribution and sale of
drugs.
• Central Government is primarily concerned, a Bill to regulate
the import of drugs into British India was introduced in the
Legislative Assembly in 1937.
• The Central Legislative Assembly passed the Drugs and
Cosmetics Bill which received the assent of the Governor
General on 10th April, 1940 and thus became the Drugs and
Cosmetics Act, 1940.
 IMPORTANT MILESTONES IN DRUG LEGISLATION
OF INDIA

• 1940 - Drugs Bill introduced in Parliament and Drugs act

later amended to Drugs & Cosmetic Act
• 1946 - Indian Pharmaceutical Codex (I.P.C) published.
• 1948 -- The Pharmacy Act, 1948 & The Dentists Act, 1948
enacted
• 1955 -- First Indian Pharmacopoeia published.
• 1970 -- First DPCO (Drugs Price Control Order)
• 1985 -- The Narcotic Drugs & Psychotropic Substances Act
enacted.
 Drugs and Cosmetic Act 1940
• Indian pharmaceutical GMP, GLP, GCP guidelines are given in
Drugs and Cosmetic Act 1940.
• The drug manufacturing, quality and marketing is regulated in
accordance with the Drugs and Cosmetics Act of 1940 and Rules
1945.
• Rules are given for pharmaceuticals and schedules are there to
comply those rules.
• Pharmaceutical industries in India those are manufacturing the
drug products for domestic market have to follow the Drugs and
Cosmetic Act.
• It extends to whole of India.
• It contains 168 rules and 25 schedules.
• Different types of forms are also given for different approvals
from drug authorities.
LIST OF AMENDING ACTS:

• The Drugs and Cosmetics (Amendment) Act, 1955

• The Drugs and Cosmetics(Amendment) Act, 1960
• The Drugs and Cosmetics (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, 1986
• The Drugs and Cosmetics (Amendment) Act, 2013
 Central Drugs Standard Control
Organization (CDSCO)
• In India, the central government, via the Central Drugs
Standard Control Organization (CDSCO) under the ministry of
Health and Family Welfare, largely works on developing
standards and regulatory measures for drugs, diagnostics and
devices.
• By laying down regulatory measures by amending acts and
rules.
• By regulating the market authorization of new drugs.
 CDSCO
• Headed by Drug Controller General of India (DCGI).
• Assisted by Deputy Drug controller
• Assistant Drug Controller
• Technical Officers
• Assistant secretary for revision of Pharmacopoeia
 RESPONSIBILITIES OF CDSCO
1. Maintain quality of drugs
• CDL, Kolkata tests drugs, antibiotics, vitamins etc.
• CRI, Kausali tests sera, vaccines, toxics.
• IVRI, Izaatnagar tests veterinary biological products.
• Central drug testing labs
2. Approve new drugs
3.Arranging meetings(DTAB and DCC)
4. Approval for license for manufacture of blood and blood
products.
 State Drugs Control Organization
• The State Drugs Control Organization is responsible
– for licensing drug manufacturing and sales
– licensing drug testing laboratories
– approving drug formulations for manufacture
– carrying out pre- and post-licensing inspections
– overseeing the manufacturing process for drugs
manufactured by respective state units and those marketed
in the state.
 Functions Of State Drug Control
Organization

• Controls manufacture, sale and distribution of drugs in its

territory.
• Headed by State Drug Controller.
• Deputy Drug Controller
• Drug Inspectors.
 STATUTORY BODIES
DRUG TECHNICAL ADVISORY BOARD(DTAB)

• Comprises 18 members
• Advice Central and state government about technical matters arising out
of drug control .

DRUGS CONSULTATIVE COMMITTEE

• Comprises 2 representatives of Central government and one from each

state.
• Enforces Drug control measures in states.
• Mainly concerned with framing of rules for all India implementation.
Chapter I
• “Drug”- 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.

• “Drug”- such substances (other than food) intended to affect

the structure or any function of 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.
• “Drug”- All substances intended for use as components of a
drug including empty gelatin capsules.

• “Drug”- 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.

• “Cosmetic” -means any article intended to be rubbed, poured,

sprinkled 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
• “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.
• “to import”
– with its grammatical variations and cognate expressions
means to bring into India.
• “patent or proprietary medicine”
–In relation to Ayurvedic, Siddha or Unani systems of medicine all
formulations containing only such ingredients mentioned in the
formulae described in the authoritative books of Ayurveda,
Siddha or Unani 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 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 Indian Pharmacopoeia for the time
being or any other Pharmacopoeia authorized in this behalf by
Central Government after consultation with the Drugs Technical
Advisory Board.
Chapter II
This chapter deals with the regulatory bodies:

• THE DRUGS TECHNICAL ADVISORY BOARD

• THE CENTRAL DRUGS LABORATORY
• THE DRUGS CONSULTATIVE COMMITTEE
 Drug technical Advisory Board

• Central Government constitute a board to advice Central

Government and State government on technical matters
arising out of D&C Act
• Board consists of 18 members
– 8 ex-officio members
– 5 Nominated members
– 5 elected members
• The nominated and elected members of the Board shall hold
office for three years, but shall be eligible for re-nomination
and re-election.
• The Board may, subject to the previous approval of the Central
Government, make by-laws fixing a quorum and regulating its
own procedure and the conduct of all business to be transacted
by it.
• The Board may constitute sub-committees and may appoint to
such sub-committees for such periods, not exceeding three
years, as it may decide, or temporarily for the consideration of
particular matters, persons who are not members of the Board.
• The Central Government shall appoint a person to be Secretary
of the Board and shall provide the Board with such clerical and
other staff as the Central Government considers necessary.
 The Central Drugs Laboratory
• Central drugs Laboratory , Kolkatta is a national statuary
laboratory of the government of India for quality control of
drug and cosmetic and established under the D&C act, 1940.
• Oldest quality control laboratory of the drug control
authorities in India.
• Function under the director general of Health Services in the
Ministry of Health and Family Welfare.
 Functions Undertaken
Statuary Function:

• To act as Appellate authority.

• To function as government analyst for states who do not have
own testing facilities.
• Analytical quality control of imported drugs.
• Analytical quality control of drug formulations manufactured
within country on behalf of the Central & State Drug standard
control organization.
Other Functions

• Procurement, establishment, maintenance, storage and

distribution of I.P & International Reference standards.
• Preparation and standardization of I.P reference standards
against USP, BP primary standards.
• To undertake analytical research in standardization and
methodology development of drug.
 The Drugs Consultative Committee
• The Central Government may constitute an advisory committee to
be called “The Drugs Consultative Committee” to advise the
Central Government, the State Governments and the Drugs
Technical Advisory Board on any other matter tending to secure
uniformity throughout [India] in the administration of this Act.
• The Drugs Consultative Committee shall consist of two
representatives of the Central Government to be nominated by
that Government and one representative of each State Government
to be nominated by the State Government concerned.
• The Drugs Consultative Committee shall meet when required to
do so by the Central Government and shall have power to regulate
its own procedure.
Chapter III
IMPORT OF DRUGS AND COSMETICS
• For the purposes of this Chapter we shall see the
following:
• Standards of quality
• In relation to a drug, that the drug complies with the
standard set out in [the Second Schedule], and
• In relation to a cosmetic, that the cosmetic compiles
with such standard as may be prescribed.
 Misbranded Drug

• If it is so coloured, coated, powdered or polished that damage

is concealed or if it is made to appear of better or greater
therapeutic value than it really is.
• If it is not labelled in the prescribed manner.
• If its label or container or anything accompanying the drug
bears any statement, design or device which makes any false
claim.
 Adulterated Drugs
• If it consists, in whole or in part, of any filthy, putrid or decomposed
substance.
• 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.
• If its container is composed in whole or in part, of any poisonous or
deleterious substance which may render the contents injurious to health.
• If it bears or contains, for purposes of colouring only, a colour other
than one which is prescribed.
• If it contains any harmful or toxic substance which may render it
injurious to health.
• If any substance has been mixed therewith so as to reduce its quality or
strength.
 Spurious Drug
• If it is imported under a name which belongs to another drug.
• 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 unless it is plainly and
conspicuously marked so as to reveal its true character and its lack of
identity with such other drug.
• If the label or the container bears the name of an individual or company
purporting to be the manufacturer of the drug, which individual or
company is fictitious or does not exist.
• If it has been substituted wholly or in part by another drug or substance.
• If it purports to be the product of a manufacturer of whom it is not truly
a product.
 Misbranded Cosmetic

• If it contains a colour which is not prescribed

• If it is not labelled in a prescribed manner.
• If the label or container or anything accompanying
the cosmetic bears any statement which is false or
misleading in any particular.
 Spurious cosmetic
• If it is imported under the name which belongs to another
cosmetic.
• If it is an imitation of, or is a substitute for, another cosmetic or
resembles another cosmetic in a manner likely to deceive or bears
upon it or upon its label or container the name of another cosmetic,
unless it is plainly or conspicuously marked so as to reveal its true
character and its lack of identity with such other cosmetic
• If the label or the container bears the name of an individual or
company purporting to be the manufacturer of the cosmetic, which
individual or company is fictitious or does not exist
• If it purports to be the product of a manufacturer of whom it is not
truly a product.
Prohibition of import:
• Any drug which is not of standard quality
• Any misbranded drug or cosmetic
• Any cosmetic containing any ingredient which may render it
unsafe or harmful
Chapter IV
MANUFACTURE, SALE AND DISTRIBUTION OF
[DRUGS AND COSMETICS]
• Standard of quality
• Adulterated drugs
• Spurious drugs
• Misbranded cosmetics
• Spurious cosmetics
 Powers of Inspectors
An Inspector may, within the local limits of the area for which he
is appointed
• Inspect
– Any premises wherein any drug or cosmetic is being
manufactured and the means employed for standardising
and testing the drug or cosmetic.
– Any premises wherein any drug or cosmetic is being sold,
or stocked or exhibited or offered for sale, or distributed.
• Take samples of any drug or cosmetic
– Which is being manufactured or being sold or is stocked or
exhibited or offered for sale, or is being distributed.
– From any person who is in the course of conveying,
delivering or preparing to deliver such drug or cosmetic to
a purchaser or a consignee.
 Powers of Inspectors
• At all reasonable times, with such assistance, if any, as he
considers necessary
– Search any person, who, he has reason to believe, has
secreted about his person, any drug or cosmetic in respect
of which an offence under this Chapter has been, or is
being, committed
– Enter and search any place in which he has reason to
believe that an offence under this Chapter has been, or is
being, committed
– Stop and search any vehicle, vessel or other conveyance
which, he has reason to believe, is being used for carrying
any drug or cosmetic in respect of which an offence under
this Chapter has been, or is being, committed.
CHAPTER V

• MISCELLANEOUS