Regulation of drug sector in India

REGULATION OF DRUG SECTOR IN
INDIA
PRESENTED BY,
SHARATH GOWDA
III/I
29-12-20151

CONTENTS
 DEFINITION
 INTRODUCTION
 DRUG REGULATORY BODIES
 CDSCO
 NPPA
 DRUG LAWS
 GOOD MANUFACTURING PRACTICES
 DEFICIENCY AND LIMITATIONS
 RECENT REGULATORY INITIATIVES
29-12-20152

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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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

 Hence effective drug regulation is required to
ensure the safety, efficacy and quality of
drugs.
29-12-20155

 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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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.
29-12-20157

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.
29-12-20158

 Apart from these ministries, The
Department of Chemicals and
Petrochemicals also oversees policy,
planning, development and regulation
pertaining to the pharmaceutical sector.
29-12-20159

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.
29-12-201510

 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.
29-12-201511

 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.
29-12-201512

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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NPPA
 Drugs with high sales and a market share
of more than 50% are subjected to price
regulation.
29-12-201515

NATIONAL
GOVERNMENT
Ministry of Chemicals
and fertilisers
Ministry of health and
family welfare
CDSCO NPPA
Department of
Chemicals &
petrochemicals
Drugs
Controller
General of
India
29-12-201516

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
29-12-201517

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.
29-12-201518

 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.
29-12-201519

 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.
29-12-201520

APPROVAL OF INVESTIGATIONAL
NEW DRUG
29-12-201521

CENTRAL LICENSING
29-12-201522

 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.
29-12-201523

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.
29-12-201524

 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.
29-12-201525

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.
29-12-201526

Phase-wise break-up of clinical trials carried
out in India
29-12-201527

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.
29-12-201528

 Need for greater coordination and
transparency in functioning among
different ministries concerned with drug
regulation.
29-12-201529

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

Regulation of drug sector in India

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Regulation of drug sector in India