concept of regulated & non-regulated market which important for medicines which is imported for import & export of pharmaceutical products.

1. CONCEPT OF REGULATED
AND NON REGULATED
MARKET
by:-
rashmi nasare,
M. Pharm 1st yr
(PharmaceuticalQuality Assurance)
Gurunanakcollege ofPharmacy
Under the guidance of
Dr. S.R.WALDE

2. CONTENTS
 INTRODUCTION
 REGULATED MARKET
 NON REGULATED MARKET
 DRUG REGULATIONS
 DRUG DEVELOPMENTS
 REGULATORY BODIES
To be continue

3. Regulated market in the Pharmaceutical
industry
Basically medicines after clearing all pre-requisites
for sales and marketing enter the current world at
specified prices. In spite of clearing all the
requirements like human testing, animal testing, bio-
equivalence…..the MAH(marketing authorization
holder i.e the pharmaceutical manufacturer or
distributor) should get proper approvals to market any
drug in the market.
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4. Regulated: Example: Major big countries with specific
authorities/monitoring bodies to look after health of its
citizens-EU, US, JAPAN, AUSTRALIA, CANADA,
INDIA and DENMARK….
 These countries have well-defined procedures for
marketing and distribution of pharmaceuticals
both for human and veterinary use. MAHs should
file applications to market their drugs with all the
supportive and required data. 3

5. Non-regulated market in pharmaceutical
industry :
Non-regulated: Small to very countries which do not
have any specific authorities which controls the supply
of medicine. One can consider newly formed countries,
small population countries and under developed
countries. AFRICAN countries, Asian countries
Being said since these countries do not have specific
monitoring authorities, they depend on other regulated
countries. If particular product is marketed in any of
the regulated countries….then marketing in these
countries is very easier. 4

6.  Non-regulated markets, they are becoming an
important player in drug manufacture, in particular,
the production of generics. Many of the generics
produced are now found in all parts of the world
 Unregulated products, however, are not required to
meet any of these standards and are not subjected by
law to any evaluation or follow-up in the
marketplace. As long as they do not claim to cure any
particular disease or ailment, they are not subjected to
the rigorous clinical processes described. 5

7.  Drug Laws
 Drug Regulatory Agencies
 Drug Regulatory Boards
 Quality Control
 Drug Information Centres etc.
The drug regulation
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8.  Product registration (drug evaluation and
authorization, and monitoring of drug efficacy
and safety ).
 Regulation & Control of drug promotion and
information.
 Adverse drug reaction (ADR) monitoring.
 Regulation of drug manufacturing ,importation
and distribution
Key function of regulatory agencies
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9.  A regulatory process by which person /organization /
sponsor / innovator gets authorization to launch a drug in a
market is known as drug approval process .
 In general drug approval process comprises of various
stages: application to conduct clinical trials, conducting
clinical trials, application to marketing authorization of
drug and post -marketing studies.
Regulatory Process
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10.  Every country has its own regulatory authority, having
an overall objective of a stringent drug approval
system is to ensure that medicinal products of
acceptable quality and efficacy are manufactured
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11. Methods For Drug Development

12.  The United States has perhaps the world’s most
stringent standards for approving new drugs. Drug
approval standards in the United States are considered
by many to be the most demanding in the world.
Following are the application to be done
Investigational New Drug (IND) Application
New DrugApplication (NDA)
Abbreviated New DrugApplication (ANDA)
Drug Approval in United States
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13.  It’s an application filed to the FDA in order to start
clinical trials in humans if the drug was found to be
safe from the reports of Preclinical trials.
 The IND application is not a request for permission to
market a new drug; instead, it is an exemption from the
statutory prohibition against shipping experimental
drugs in interstate commerce without FDA approval..
Investigational New Drug (IND) Application
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14. New Drug Application (NDA)
If clinical studies confirm that a new drug is relatively safe
and effective, and will not pose unreasonable risks to Patients,
the manufacturer files a New Drug Application (NDA), the
actual request to manufacture and sell the drug in the United
States.
The NDA must include all data from animal and laboratory
testing, comprehensive information about the drug’s chemistry
and pharmacology, and the complete results of all clinical
investigations
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15. It’s an application made for approval of Generic Drugs. An
ANDA is considered “abbreviated” because the sponsor is
not required to reproduce the clinical studies that were done
for the original, brand name product.
Instead, generic drug manufacturers must demonstrate that
their product is the same as, and bioequivalent to, a
previously approved brand name produce .
Abbreviated New Drug Application (ANDA)
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16. Drugs and Health is in concurrent list of Indian
Constitution It is governed by both Centre and State
Governments under the Drugs & Cosmetics Act,
1940.
Drug regulatory system in India
MAIN BODIES
 Central Drug Standard Control Organization
(CDSCO)
 Ministry Of Health & Family Welfare (MHFW)
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17.  Indian Council Of Medical Research (ICMR)
 Drug Technical Advisory Board (DTAB)
 Central Drug Testing Laboratory (CDTL)
 Indian Pharmaceutical Association (IPA)
 Indian Pharmacopoeia Commission (IPC)
 National Pharmaceutical Pricing Authority
(NPPA)
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18. The Approval process in India
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19. Central Drugs Standard Control
Organization
The Central Drugs Standard Control
Organization (CDSCO) is the national regulatory
body for Indian pharmaceuticals and medical
devices, and serves parallel function to the European
Medicines Agency of the European Union, the
Pharmaceutical and medical device agency PMDA
of Japan, the Food and Drug Administration of the
United States and the Medicines and Healthcare
products Regulatory Agency of the United Kingdom.

20. Within the CDSCO, the Drug Controller General of
India (DCGI) regulates pharmaceutical and medical
devices, under the gamut of Ministry of Health and
Family Welfare. The DCGI is advised by the Drug
Technical Advisory Board (DTAB) and the Drug
Consultative Committee (DCC). It is divided into
zonal offices which do pre-licensing and post-
licensing inspections, post-market surveillance, and
recalls when needed.
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21. Central Drug Standard Control Organization
 Head quarters New Delhi
 North Zone Ghaziabad
 West Zone Mumbai
 South Zone Chennai
 East Zone Kolkata.
 Other zonal offices Ahmedabad and
Hyderabad.
 Laboratories 6
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22. CDSCO Drug Controller General (I)
Head Quater
Zonal & sub
Zonal office
Port
Office
Laboratory
New Drugs
CLAA
Imports
DTAB/DCC
GMP Audits
Coordinates
with states
Import
Export
Testing of drug
samples
Validation of
Test Protocol
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23. Functions undertaken by Central
Government Statutory function
 Laying down standards of drugs, cosmetics,
diagnostics and devices
 Laying down regulatory measures, amendments to
Acts and rules.
 To regulate market authorization of new drugs.
 To regulate clinical research in India
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24.  To approve licenses to manufacture certain
categories of drugs as Central License Approving
Authority(CLAA) i.e. for Blood Banks, Large
Volume Parenteral and Vaccines & Sera.
 To regulate the standards of imported drugs.
 Work relating to the Drugs Technical Advisory
Board ( DTAB ) and Drugs Consultative Committee
(DCC).
 Testing of drugs by Central Drugs Labs. 23

25. Examination
report
Central licensing
manufacturer
State licensing
authority
Joint inspection by
state and central
inspector
License prepared by
state licensing authority
CLAA approval and
grant of licence

26. REFERENCES
 DRUG REGULATORY AFFAIRS by sachin
itkar, Dr. S.wyavahare
 www.fda.gov/cder/guidance/index.htm
 www.fda.gov/cber/cberftp.html
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