Drug Regulatory Affairs

Presented by : Navdeep Saini

M. Pharm, Ph.D
Department of Quality assurance
Mandsaur Institute of Pharmacy, Mandsaur
(M. P.)
Contents

* Defination
*Federal Food , Drug and Cosmetic Act
*Drug Amendment
*Kefauver -Harris Amendment
*OTC Review
*Patent Copy Rights
*Trade marks
*Product liabilities
Drug

 A) articles recognized in the official United

States Pharmacopoeia, official Homoeopathic
Pharmacopoeia of the United States, or official
National Formulary, or any supplement to any of
them.
 (B) articles intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of
disease in man or other animals.
 (C) articles (other than food) intended to affect
the structure or any function of the body of man
or other animals
 (D) articles intended for use as a component of
any article specified in clause
 (D) articles intended for use as a component of
any article specified in clause (A), (B), or (C) ;but
does not include devices or their components
parts or accessories.
 Drug Definition 

 Established by FDCA
 Articles recognized as official by USP,
Homeopathic Pharmacopoeia, NF to treat
disease.
 Counterfeit Drug 

 A drug whose container or label bears

trademark, trade name or other identifying
mark, imprint or device, likeness…
 Without legal authorization
 Recent increase in counterfeiting of high cost
drugs
 Device 

 instrument, apparatus, implement, machine,

contrivance, implant, in vitro reagent, or
other similar or related article, including any
component, part, or accessory
 Intended to diagnose or treat diseases
 Labels and Labeling 

 Label:  Display of written material on the

product’s container and on the outside
container or wrapper, if any.
 Labeling:  All labels and other written,
printed, or graphic matter on any container or
wrapper or material accompanying the
product (package insert, advertising)
 Adulterated Drugs 

 If it consists in whole or in part of any filthy, putrid or

decomposed substance
 If it has been prepared, packed or held under unsanitary
conditions whereby it may have been contaminated with
filth, or whereby it may have been rendered injurious to
health
 If the strength differs, or quality or purity fall below label
standards
  
 
 Current Good Manufacturing Practice (GMP) 

 A drug is adulterated unless it is manufactured in

accordance with GMP
 GMP establishes minimum requirements for facilities,
manufacturing controls, processing , packaging.
 Pharmacies are not subject to GMP unless they are
manufacturing Rx products for resale to other
pharmacies, physicians or retail outlets
  
 Misbranded Drugs (Definition) 

 If the label is false or misleading

 Label must contain name/place of business
 Accurate statement of contents
 If  required information is not displayed as
required
 Label must warn of habit forming drugs
 Misbranding occurs if one drug is an imitation of
another drug   
More likely with high cost drugs eg
 Major Federal Drug Laws 
(Federal means :a system in which state unit
under a central authority but are
independent in internal affairs.)
 Food Drug and Cosmetic Act
 Federal Alcohol Tax
 Poison Prevention Packaging Act
 OBRA 90
 Controlled Substances Act
 Sources of Federal Law 

 Constitution
 U.S. Congress (House of Representatives and
Senate)
 Federal Agencies (FDA, DEA, CMS, FTC…)
 Courts (Common Law)
 Regulatory Agencies 

 Oregon Board of Pharmacy

 Drug Enforcement Administration (DEA)
 Food and Drug Administration (FDA)
 Oregon Public Health Services
 Centers for Medicare and Medicaid Services
(CMS)
 Federal Trade Commission (FTC)
 Joint Commission on Accreditation of Healthcare
Organizations (JCAHO)
 History of Food and Drug Law 

 1906 Pure Food and Drug Act

 1938 Food, Drug, and Cosmetic Act
 1951 Durham-Humphrey Amendment
 1958 Food Additives Amendment
 1960 Color Additives Amendment
 1962 Kefauver- Harris Amendment
 1976 Medical Device Amendments
 1983 Orphan Drug Act
 1984 Drug Price Competition/Patent Term
Restoration Act
 1987 Prescription Drug Marketing Act
 1990 Nutrition Labeling and Education Act
 1992 Prescription Drug User Fee Act
 1994 Dietary Supplement Health and
Education Act
 1997 Food and Drug Modernization Act
  
 1906 Pure Food and Drug Act 

 1. Protect public from adulterated and

misbranded food and drugs
 2. States took limited action to solve problem
of interstate commerce
 3. Secure a uniform law throughout the U.S. 
 1938 Food Drug and Cosmetic Act 

 Is current law of the land, as amended.

 Gave the Federal Govt power to establish product safety,
but did not mention efficacy
 Regulates Drug quality
 No new drug can be marketed until proven safe under
conditions described on the label
 required all drugs to be labeled with “adequate directions
for use”
  
 
 1951 Durham-Humphrey Amendment 

 Established the category of “prescription”

drugs
 Established the OTC (non-prescription)
category of drugs
 Kefauver-Harris Amendment 1962 

 Required proof of efficacy and strengthened safety requirements

 Thalidomide tragedy occurred at this time , in which thousands of
children were born with birth defects as a result of their mothers
taking thalidomide for morning sickness during pregnancy.
 Manufacturers had to evaluate pre-1962 drugs for efficacy
 Led to DESI - Drug Efficacy Study implementation
 National Academy of Sciences reviewed 50,000 + Rx/OTC Products
 Established Good Manufacturing Practices (GMP)
 Strengthened clinical trial safeguards/adverse reaction reporting
  
 
 The Kefauver Harris Amendment
strengthened the
U.S. Food and Drug Administration's control
of experimentation on humans
 and changed the way new drugs are
approved and regulated.
OTC (Over-the-Counter)
Review
 The OTC Review is the name of the process
established in 1972 by the U.S. Food and Drug
Administration (FDA) to review the safety
and efficacy of OTC ingredients, doses,
formulations, and labeling used in medicines
available to consumers without a
prescription.
purpose of the OTC Review

 FDA Commissioner Charles C. Edwards,

M.D., stated that he intended:
 “. . . to build a permanent system offering all
American consumers the best possible
assurance that every over-the-counter drug . .
. not only is safe and adequately labeled, but
that it will do what the manufacturer claims it
will do. . . “
Historical background

 FDA assembled panels made up of

physicians, pharmacists, and other
specialists.
 Each panel also included two nonvoting
members, one for industry and one
representing consumers
 Each panel was charged with examining one
or more categories of OTC medicines such as
cough and cold, antacids, laxatives
 The panels were then asked to decide which
ingredients to recommend to FDA as:
 1) generally recognized as safe and effective (or
GRAS/GRAE)
2) not generally recognized as safe or effective, or
3) needing more studies before a GRAS/GRAE
determination could be given.
 After each panel reported its findings to FDA, the
information was published for public comment.
 The results, including FDA’s own reactions, were
then published as tentative final monographs with
another comment period.
 FDA then analyzed comments and issued a final
monograph.
 Monograph
 A monograph is a regulatory standard for ingredients.
 It is a kind of “recipe book” covering acceptable
ingredients, doses, formulations, indications, and
labeling
 . Any OTC medicine that conforms to the monograph
may be manufactured and sold without an individual
product license.
 Final monographs are published in the government’s
Code of Federal Regulations (CFR).
Intellectual Property
Rights 
 CONCEPT OF PROPERTY 

 Natural object becomes a resource when it satisfies a

human want
 A resource possessed and owned becomes a property
 A bundle of legal rights linked to ownership and
possession of an item
  (Tangible: related to physical objects)
  
 
 INTELLECTUAL PROPERTY 

 It is the PROPERTY CREATED BY APPLICATION

OF HUMAN MIND
 Intangible (non-physical) in nature- derives value from
ideas
 There is no uniform definition of IP
 In knowledge age, IP is a key to techno-economic
growth
  
 
 IP UBIQUITOUS IN LIFE 

 Articles of food, furniture, clothing, textiles,

cosmetics, pharmaceuticals, entertainment
gadgets, machinery, books, etc. are all IP
protected.
 Domain of IP is ever expanding with advent of
Technology and Globalization : GI, IC topography
(local geo)are new additions, Biodiversity are
likely additions
 RATIONALE BEHIND IP 
 The creative activity culminating in IP is necessary
for socio-economic progress
 Material incentives and rewards encourage
greater creative activity
 IP rights grant monopoly to ensure rewards
 The interests of owner and society are balanced
by limiting periods of monopoly with obligation to
disclose and remedies against abuse of rights
 Disclosure brings knowledge in public domain
 NATURE OF IPRs 
 Essentially negative rights to stop others from
copying or counterfeiting
 In patents, being first with an invention pre-empts any
right of another making same invention independently.
 In copyrights, the right is diluted as right is over the
form of expression and not over idea.
 IPRs being statutory rights are legally enforceable.
 They are territorial (ownership) in nature.
 7 MAIN IP INSTRUMENTS 

 Patents
 Trademarks, Trade Names & Services Marks
 Geographical Indications
 Industrial Designs
 Layout-designs of Integrated Circuits
 Trade Secrets
 Copyrights And Related Rights
 First six are Industrial Property Rights
  
 
Patents

 It is a limited right granted by the state to an

inventor in respect of an invention to exclude
any other person from practicing the
invention
 i.e. manufacturing, using or selling the
patented product or from using the patented
process, without due permission. 
WHAT CAN BE PATENTED? 

 Inventions in all fields of technology, whether

products or processes, if they meet the criteria of
 Being patentable subject matter;
 Novelty;
 Non-obviousness (inventive step);
 Industrial application (utility).
  
 
Conditions of
Patentability 
 Novelty: Invention not known to public prior to
claim by inventor
 Inventive Step: Invention would not be obvious
to a person with ordinary skill in the art
 Industrial Application: Invention can be made or
used in any useful, practical activity as distinct
from purely intellectual or aesthetic one
  
 
 SOME EXCLUSIONS FROM
PATENTABILITY 
 Naturally occurring substances/elements;
 Diagnostic, therapeutic and surgical methods of
treatment of humans or animals;
 Plants and animals other than μ-organisms;
 Essentially biological processes for production of
plants or animals;
 Inventions whose use is contrary to public order or
morality.
 Ideas, methods for business, playing games,
performing mental acts
Advantages Of A Patent To  
The Public 
 KNOWLEDGE OF INVENTION ADDS TO
 SCIENTIFIC BACKGROUND FORMING
 BASE FOR FURTHER RESEACH 

 REASONABLE ASSURANCE FOR

 COMMERCIALIZATION 

 PATENT- OPEN TO PUBLIC FOR USE

 AFTER ITS TERM EXPIRES
Alternative to Drug
Patents: 
Publicly Financed Research 
 National Institutes of Health get $30 billion a
year
 The Free Market Drug Act (FDMA)
 $30 billion for 10 competing research companies
 All research findings are placed in the public
domain – all drugs sold as generics
 All results published and made publicly available
 $1 billion prize fund to reward outstanding
breakthroughs
Patent Grant Procedure (In
Brief) 
 Filing of PATENT APPLICATION 
 EXAMINATION & NOVELTY SEARCH  
 ACCEPTANCE OR REFUSAL
 NOTIFICATION OF “ACCEPTANCE” IN
THE GAZETTE OF INDIA (part III
section 2) 
 OPPOSITION (if any) 
 GRANT OF A PATENT  
 
 TRADEMARKS
 
 TRADEMARK, SERVICE MARK,  
and TRADE NAME 

 Distinctive symbols, signs, logos that help consumer to

distinguish between competing goods or services.
 A trade name is the name of an enterprise which individualizes
the enterprise in consumer’s mind.
 Legally not linked to quality.
 In fact, linked in consumer’s mind to quality
expectation. 
 
 To register a trade mark , the mark must
be:-
 distinctive, and, not deceptive, or contrary to
law or morality, and, not identical or similar
to any earlier marks for the same or similar
goods.
  
 
CRITERIA OF TM
PROTECTABILITY 
 Non-deceptive ( to avoid misleading)
 Not contrary to public order, morality
 Special Requirements
 A mark is registered for specified classes of
goods or services.
  
 
 TYPES OF MARKS 
 Well Known Trade Mark
 Collective Mark: Proprietor is an association of
persons, which is legally not a partnership
 Certification Mark: Does not indicate origin of
goods but certifies the goods as conforming to
certain characteristics (quality, ingredients,
geographical origin etc.) e.g. ISI, AGMARK,
Hallmark etc.
What is protected and  
what’s not? 
 Right to use TM in relation to goods/ services
as registered are protected (If TM consists of
several parts, protection is for TM as a whole)
 State Emblems, Official Hallmarks, Emblems
of Intergovernmental Organizations cannot
be used as TM.
Forms of TM 

 Visual: Words, letters, numerals, devices

including drawings and symbols or 2-D
representations of object or a combination of
two or more of these, colour combinations or
colour per se, 3-D sign as shape of goods or
packaging.
 Audio: Sounds, Musical Notes
 Olfactory: Smells
 GEOGRAPHICAL
INDICATIONS
 What is GI? 

 Many goods possess their peculiar properties due

to their geographical origin.
 GI is the best method to indicate the geographical
origin of goods and services.
 Many agricultural products (tea, rice); dairy
products (cheese), wines and spirits (Champagne)
owe their special quality and reputation to their
geographical place of growth or processing
Protection of GI 
 GI is not owned by a single owner
 Any producer in the region can use the GI on the
product provided it is prepared by the norms set
out for the use of that GI.
 GI is registered in the national register and is
similar to the certification mark identifying the
origin of the good.
 Govt. can register GI in the international register
maintained by WIPO for world wide protection.
 It is an offence to use false GI on goods
Industrial Designs

 What are Industrial Designs? 

 The ornamental or aesthetic aspect of an

article that enhances visual appeal and
differentiates product.
 e.g. 3-D features of shape or surface as of a
perfume bottle, 2-D patterns of lines, shapes
and colours as on a bed sheet
Criteria for Protection as
ID 
 New and Original
 Capable of mass production or application on an
article of utility
 Not contrary to public order or morality
 The shape should not be determined merely by
the functionality of the good
Comparison of ID against
TM 
 ID
 Has to be integral part of product
 Should be original and new but need not be
distinctive
 TM
 Is applied on the product but need not be
embodied in it.
 Should be distinctive
  
 
 ID Protection 

 Protects commercial exploitation of the

design idea through products/articles that
embody it or reproduce it and not the articles
themselves.
Integrated Circuit Layout
Designs
 What is Layout Design? 

 Layout of transistors and other circuit

elements, including lead wires connecting
such elements and expressed in any manner
in a semiconductor integrated circuit (IC).
  
 
 Why to protect? 

 IC Layouts are creations of human mind;

 There is lot of investment of time and money in
the creation but copying is very cheap;
 Fertile area with new circuit designs made every
day to cater for miniaturization and novel
applications.
 Why special protection? 

 There may not be novelty so cannot be

patented;
 Copyright protection does not return the
investments since commercial life of a design
is limited.
Protection is against…

 Act of reproducing a layout design fully or in

parts;
 Importing, selling or distributing
commercially a protected layout design or IC
incorporating it.
  
But identical design created independently by
third party is not prohibited
 Trade Secret 
 The best kept secret till date
 Some inventions, data, information cannot be
protected by any of the available means of IPRs.
Such information is held confidential as a trade
secret
 Trade secret can be an invention, idea, survey
method,manufacturing process, experiment
results, chemical formula, recipe, financial strategy,
client database etc.
 When Trade Secrets are preferred?  

 When invention is not patentable;

 Patent protection is limited to 20 years, when
secret can be kept beyond that period;
 When cost of patent protection are prohibitive;
 When it is difficult to reverse engineer
  
 . How to guard Trade Secret?
 Restricting number of people having access to
secret information
 Signing confidentiality agreements with business
partners and employees
 Using protective techniques like digital data
security tools and restricting entry into area where
trade secret is worked or held
 National legislations provide protection in form of
injunction and damages if secret information is
illegally acquired or used.
  
Copyright
 Copyright protects literary and artistic works
 e.g. Books, lectures, dramatic and musical
works, choreography, cinematography,
drawings, paintings, architecture, sculpture,
photographs, illustrations, maps, plans
sketches etc.
 This is automatic right created with the
creation of work and no registration is
required
Rights covered under CR 

 Moral Rights : Author’s right of paternity.

Non-alienable.
 Economic Rights : Rights to exploit the work.
e.g. Rights of translation, rights of
performance, rights of reproduction etc.
These rights can be transferred, assigned,
licensed for economic benefits.
 Who are the Authors? 

 Writer/writers of the book;

 Painter;
 Music composer;
 Translator;
 Cinematographer;
 Photographer etc
Duration of Protection 

 For books and other works of arts it is 50 to 70

years after the death of the author (the laws
of different countries vary);
 For photographic work 25 years from making
the work;
 For cinematic works 50 years after making
the work available to public.
Exceptions to Protection 
(Free Use or Fair Deal
 Quotations for commentary;
 Illustration for Teaching;
 Current News Reporting etc.
  
Free Use is decided by amount of work used
and its economic implications to the right
holder. The mention of original author/source
is must.
International Agreements 

 Paris convention for the protection of

Industrial Property (1883)
 Berne convention for protection of Literary
and Artistic Works (1886)
 Agreement on Trade Related Aspects of
Intellectual Property Rights (TRIPS) (1994)
Emerging Issues in IPR 

 Traditional Knowledge and Expression of

Culture (Folklore)
 Biodiversity and Genetic Resources
 Electronic Commerce;
 Internet Domain Names;
 Protection of databases, software
  
 

Conclusion 
 Patents and copyrights are forms of
government intervention which are intended to
serve a public purpose
 There are enormous inefficiencies associated
with patents and copyrights
 Patents and copyrights encourage antisocial
rent-seeking behavior
 There are alternatives; they must be debated
  
 
Thank you!