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Regulation of drug sector in India
1. REGULATION OF DRUG SECTOR IN
INDIA
PRESENTED BY,
SHARATH GOWDA
III/I
29-12-20151
2. CONTENTS
DEFINITION
INTRODUCTION
DRUG REGULATORY BODIES
CDSCO
NPPA
DRUG LAWS
GOOD MANUFACTURING PRACTICES
DEFICIENCY AND LIMITATIONS
RECENT REGULATORY INITIATIVES
29-12-20152
3. DEFINITION
Quality control is a procedure or set of
procedures intended to ensure that a
manufactured product or performed service
adheres to a defined set of quality criteria or
meets the requirements of the customer.
“To regulate means to control something so
that it functions properly.”
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4. INTRODUCTION
Drugs play an important role in the health
of both people and the economy of a
country.
Its quality is critical to patient health and
poor quality can lead to-
Treatment failure
Adverse effects
Prolonged illness
Distrust in healthcare system
Waste of limited financial resources
Death 29-12-20154
5. Hence effective drug regulation is required to
ensure the safety, efficacy and quality of
drugs.
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6. The drug regulation mainly consists of:
1. Drug Regulatory Bodies
2. Drug Laws
3. Quality Control
4. Drug Information Centers etc.
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7. Drug Regulatory Bodies
The principal regulatory bodies entrusted
with the responsibility of ensuring the
approval, production and marketing of
quality drugs in India at reasonable prices
are:
Central Drug Standards and Control
Organization(CDSCO).
National Pharmaceutical Pricing
Authority(NPPA).
Drug Controller General of India.
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8. DRUG POLICY FORMULATION IN
INDIA
Drug policies in India are formulated by
the Ministry of Chemicals and Fertilizers
and the Ministry of Health and Family
Welfare.
The former takes the decision on pricing
of drugs and the latter looks into quality,
manufacture, sales and distribution of
drugs.
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9. Apart from these ministries, The
Department of Chemicals and
Petrochemicals also oversees policy,
planning, development and regulation
pertaining to the pharmaceutical sector.
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10. Central Drug Standards and
Control Organization(CDSCO)
It runs under the aegis of The Ministry of
Health and Family Welfare.
Established under the Drugs and
Cosmetics Act 1940.
Objective- prescribes standards and
measures to ensure the safety, efficacy
and quality of drugs, cosmetics,
diagnostics and devices in the country.
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11. regulates the market authorization of new
drugs and clinical trials standards.
supervises drug imports and approves
licences to manufacture the drugs by
acting as Central License Approving
Authority(CLAA).
Regulates the clinical research.
Guidance on technical matters.
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12. CDSCO is headed by the Drugs Controller
General of India.
It has a network of 6 zonal offices and 4
sub-zonal offices and 7 port offices.
Port offices monitor import and export of
drugs.
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14. NATIONAL PHARMACEUTICAL
PRICING AUTHORITY(NPPA)
NPPA was established, to fix/ revise the
prices of controlled bulk drugs and
formulations and to enforce prices and
availability of the medicines in the
country, under the Drugs Prices Control
Order(DPCO), 1995.
Pricing policy and industry regulation
constitutes the key responsibility of the
NPPA.
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15. NPPA
Drugs with high sales and a market share
of more than 50% are subjected to price
regulation.
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16. NATIONAL
GOVERNMENT
Ministry of Chemicals
and fertilisers
Ministry of health and
family welfare
CDSCO NPPA
Department of
Chemicals &
petrochemicals
Drugs
Controller
General of
India
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17. DRUG LAWS:
The quality control of the drugs marketed
in the country is regulated under the
following laws-
The Drugs and Cosmetics Act, 1940
Pharmacy Act of 1948
Drugs and Magic remedies Act of 1954
Drugs Prices Control Order 1995
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18. THE DRUGS AND COSMETICS ACT(1940)
SCHEDULES OF THE ACT
Some of the important schedules of the
Drugs and Cosmetic Acts include:
Schedule D: dealing with exemption in
drug imports.
Schedule M: deals with Good
Manufacturing Practices involving
premises and plants.
Schedule Y: specifies guidelines for clinical
trials, import and manufacture of new
drugs.
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19. Drug Controller General of India is
responsible for approval of licenses of
specified categories of Drugs such as blood
and blood products, I. V. Fluids, Vaccine and
Sera.
There exists a dual regulatory control on
drug policy.
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20. CENTRAL AUTHORITIES-
approval of New Drugs
Clinical Trials
lays down the standards
control over the quality of imported Drugs
coordination of the activities of State Drug
Control Organisations.
STATE AUTHORITIES-
issue licences for manufacture of approved
drugs.
Monitor quality control.
Distribution and sale of drugs.
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23. THE DRUGS & MAGIC REMEDIES
ACT(1954):
It controls the advertisements regarding
drugs,
it prohibits the advertising of remedies
alleged to possess magic qualities.
THE PHARMACY ACT(1948):
An Act to regulate the profession of
pharmacy.
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24. GOOD MANUFACTURING PRACTICES(GMP)
GMP constitute an international set of
guidelines for the manufacture of drugs
and medical devices in order to ensure the
production of quality products.
Objectives-
to minimize risks with reference to the
manufacturing, packaging, testing, labelling,
distributing and importing of drugs,
cosmetics, medical devices, blood and blood
products, food items etc.
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25. The WHO-GMP certification, which
possesses two-year validity, may be
granted both by CDSCO and state
regulatory authorities after a thorough
inspection of the manufacturing premises.
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26. CLINICAL TRIALS
In recent years, India has positioned itself
as one of the major players in the clinical
trials arena.
Clinical trials to establish the safety and
efficacy of drugs constitute nearly 70% of
research and development costs.
Considering the relatively low costs of
R&D in India, several MNC pharmaceutical
companies are increasingly making India a
clinical research and development hub.
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28. DEFICIENCIES & LIMITATIONS OF
DRUG REGULATORY SYSTEM
Proliferation of spurious and substandard
drugs in the Indian market.
Lack of transparency in licensing
procedures.
Inadequate regulatory expertise and
testing facilities to implement uniform
standards.
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29. Need for greater coordination and
transparency in functioning among
different ministries concerned with drug
regulation.
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30. Recent regulatory initiatives:
Move to establish National Drug Authority
so that quality regulation and price control
is performed by the same agency.
Establishment of pharmacovigilance
centres at national, zonal and regional
levels to monitor adverse drug reactions.
Move to bring nearly 374 bulk drugs
under price control.
Monitoring clinical trials by setting up of
the Clinical Trials Registry of India (CTRI).
29-12-201530