DRUGS AND COSMETICS ACT

DRUGS AND
COSMETICS ACT

Contents of this chapter

•       Definitions

•       Administration
of the act and rules

•       Provisions
related to Import

•       Provisions
related to Manufacture

•       Provisions
related to Sale

•       Labeling
and Packaging

•       Schedules
to the act and rules

Learning Objectives

•       At the end of this lecture, student
will be able to

–      Discuss the Provisions of GMP
related to manufacture of drugs and pharmaceuticals

–      Explain
the GMP guidelines

–      Discuss
the principles of GMP

–      Discuss
about Schedule M

–      cGMP
for Finished Pharmaceuticals

–      Discuss
Explain the principles of Schedule M II

–      Explain
the provisions for sale of drugs

–      Describe
the types of sale licenses

–      Discuss the Class of drug prohibited
to sale

–      Discuss the Drugs and
Cosmetics (Amendment) Act, 2008

–      Describe
the labeling aspects of drugs and cosmetics

–      Discuss the Provisions of
DTAB and DCC

–      Discuss the Provisions Govt.
Analyst and Central Drugs Laboratory

–      Discuss the Provisions
related to Licensing and Controlling Authority

–      Discuss the Provisions
related to Schedule DII

–      Discuss the Classes of Drugs
Prohibited to Import

–      Discuss the Provisions
related to import of schedule X drugs

–      Explain
the offences and penalties related to import of drugs and cosmetics

–      Explain
the provisions for drugs in Schedule X

–      Describe
the provisions for drugs for examination, test and analysis

–      Discuss
the provisions for manufacture of new drugs

–      Discuss
the provisions for loan and repacking licenses

–      Discuss
the provisions for penalties for manufacture of drugs

–      Discuss the qualifications,
functions and duties of Drugs Inspector

–      Discuss
the provisions for import of drugs under license

–      Discuss
the provisions for import & registration of Drug & Cosmetics

–      Enlist
the Schedules to the act and rules

–      Discuss the Administration of
the act and rules

–      Define the various definitions used
in Drugs and Cosmetics Act

–      Enlist
the Schedules to the act and rules

–      Discuss the Provisions
related manufacture drugs and pharmaceuticals

–      Explain
the types of manufacturing licenses

–      Describe
the prohibitions for manufacturing of drugs

–       Discuss the provisions for drugs other than
those specified in Schedule C, C₁ & X

–      Discuss
the provisions for drugs specified in Schedule C, C₁ but not
specified in Schedule X

–      Discuss
the provisions for drugs specified in Schedule C, & C₁

History

·        
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 of India……

LIST OF AMENDING ACTS AND ADAPTATION ORDERS

1. The Drugs (Amendment) Act, 1955

2. The Drugs (Amendment) Act, 1960

3. The Drugs (Amendment) Act, 1962

4. The Drugs and Cosmetics (Amendment) Act, 1964

5. The Drugs and Cosmetics (Amendment) Act, 1972

6. The Drugs and Cosmetics (Amendment) Act, 1982

7. The Drugs and Cosmetics (Amendment) Act, 1995

8. The Drugs and cosmetics (Amendment) Act, 2008

9. The Drugs and cosmetics (Amendment) Act, 2013

Objectives

v  To
regulate the import, distribution and sale of drugs & cosmetics
through licensing in order to prevent substandard or harmful drugs and
cosmetics.

v  Excise
control over the production of drugs and cosmetics in the country.

v  To
distribution and sale of drugs and cosmetics by qualified persons only.

v  To
prevent substandard in drugs.

v  To
regulate the manufacture and sale of Ayurvedic, Siddha and Unani drugs.

v  To
establish Drugs Technical Advisory Board (DTAB) and Drugs
Consultative Committees (DCC) for Allopathic and allied drugs and
cosmetics.

Definitions

Drugs:

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.

Cosmetic:

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.

Ayurveda Sidha and Unani Drugs:

Include all medicines indented for internal or external use
for or in diagnosis, treatment, mitigation or prevention of disease or disorder
in human beings or animals & manufactured exclusively in accordance with
the formulae prescribed in authoritative books of Ayurvedic, siddha and
Unani-Tibb systems of medicines.

Central License approving authority:

Means Drug Controller of India appointed by the Central
Government.

Drug: Includes

a)      all
medicines used for the internal or external use of human beings or animals and
all substances indented to be used for or in diagnosis, treatment , mitigation
or prevention of any disease or disorder in human beings or animals including
preparation applied for repelling mosquitoes

b)      substances
indented to affect the structure or any function of human body or indented to
be used for the destruction of  vermin or
insects that cause disease in human beings or animals

c)        all substances indented for use as components
of drug including empty gelatin capsules

d)      Devices
indented for internal or external use in the diagnosis, treatment, mitigation
or prevention of disease or disorder in human beings or animals.

Manufacture:

Include any process or part of 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 drugs or packing of any cosmetics or drug in ordinary course
of retail process.

Patent or Proprietary Medicine:

In relation to Ayurveda, Sidha or Unani systems of medicine
all formulations containing only such ingredients mentioned in the formulae
described in authoritative books of Ayurveda, Sidha or Unani- Tibb systems of
Medicine specified in the first schedule but does not include medicine which is
administered by parenteral route also formulations included in authoritative
books as mentioned in the first Schedule.

In relation to any other system of medicine, a drug which is
a remedy or prescription presented in form ready for internal or external
administration of human beings or animals and which is not included in edition
of the Indian Pharmacopoeia for the time being or any Pharmacopoeia authorized
in this behalf by the Central Government after constitution with the DTAB.

Misbranded drugs: A drug is deemed to be misbranded –

·        
If it is so colored, coated, powdered or
polished that damage is concealed or if it is made to appear of better or great
therapeutic value than it really is.

·        
If it is not labeled in prescribed manner; or

·        
If its label or container or anything
accompanying the drugs bears any statement, design or device which makes any
false claim for the drug or which is false or misleading in any particular.

Adulterated Drugs: A drug is deemed to be adulterated
–

·        
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 rendered injurious to health; or

·        
If its container is composed in whole or in
part, of any poisonous or delirious substances which may render the contents
injurious to health.

·        
If it bears for purpose of coloring only a color
other than one which is prescribed.

·        
If it contains any harmful or toxic substance
which may render it injurious to health; or

·        
If any substance has been mixed there with so as
to reduce its quality or strength.

Spurious Drugs: A drug is deemed to be spurious –

·        
If it is imported or manufactured under a name
which belongs to another drug.; or

·        
If it is an imitation or is a substitute for,
another drug or resembles another drug in a manner likely to deceive or unless
it is plainly and conspicuously marked so as to reveal its true character and
its lack of identity with such other drugs; or

·        
If the label or container bears the name of an
individual or company purporting to be the manufacture of the drug, which
company or individual is fictious or does not exist.

·        
If it has been substituted wholly or in part by
another drug or substance; or

·        
If it purports to be the product of a
manufacturer of whom it is not truly a product.

Misbranded Cosmetics: A cosmetic is deemed to be
misbranded –

·        
If it contains color which is not prescribe; or

·        
If it is not labeled in prescribed manner; or

·        
If the label or container of anything
accompanying the cosmetic bears any statement which is false or misleading in
particular.

Spurious Cosmetics: A cosmetic is deemed to be
spurious –

·        
If it is imported under a name which belongs to
another cosmetic; or

·        
If it is an imitation of, or a substitute for,
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
and conspicuously marked so as to reveal its true character and its lack of
identity with such other cosmetic; or

·        
If the label of the container bears the name of
an individual or company purporting to be the manufacturer of the cosmetic,
which individual or company is fictitious and does not exist; or

·        
If it purports to be the product of a
manufacturer of whom it is not truly a product.

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