NTCC REPORT PPT.ppt generic drug development and approval

Amity Institute of Pharmacy
1
B.Pharm, VIII Sem
GENERIC DRUG DEVELOPMENT AND APPROVAL
PROCESS
By
LUCKY
Under supervision of
Dr.Archana Sharma (Associate Professor)

Introduction
Generic drug is a replacement of the innovator drug that takes
many years and different stages. In pharmaceutical industry, it
takes the reference of the innovator drug but differ in scientific
and technical approach to develop a generic drug that
completely possess bioequivalence and same therapeutic
properties as innovator drug in very less time. Generic drugs
are cheaper than the branded drugs. Though it is not that easy
to develop a drug in a less time and low cost that gives
equivalent therapeutic effect as innovator drug and also meet
all the needed regulatory requirements.
2

• The active ingredients of the generic drugs remain same but
some alteration is done in the other features according to
the regulatory requirements and ultimately led to the
development of a drug that is affordable, safe and also
possess same therapeutic effect as of the innovator drugs.
Due to its affordability, generic drugs are gaining its
recognition and being widely used by the consumers instead
of the brand-name drugs globally. For the sake of
identification of potential health concerns to consumers,
FDA in the US is in charge of regulating the drug testing
procedure.
3

• The active ingredients of the generic drugs remain same but
some alteration is done in the other features according to
the regulatory requirements and ultimately led to the
development of a drug that is affordable, safe and also
possess same therapeutic effect as of the innovator drugs.
Due to its affordability, generic drugs are gaining its
recognition and being widely used by the consumers instead
of the brand-name drugs globally. For the sake of
identification of potential health concerns to consumers,
FDA in the US is in charge of regulating the drug testing
procedure.
4

While both branded drug and generic drug companies in the US must submit
applications to the FDA before being allowed to sell their products to the general
public, the former must go through expensive, three-phase pre-clinical clinical
testing in order to show theat the drug is safe and effective. Later, just needs to go
through bioequivalence testing, or testing of pharmacokinetic qualities, which
explains a large difference in costs among brand-name and generic medications and
a consequent increase in the price of brand-name analogues. The huge price
discrepancy between the two drug kinds can be partially attributed to the fact that
developing brand-name drugs is far more costly than developing generic drugs.
Brand-name medications reportedly made large income throughout their patent
exclusivity periods and continue to do so beyond. This continues due to the fact
that consumers frequently buy brand-name medications even if they are aware that
generic medications are available.
5

GENERIC DRUG AND BRANDED DRUG
A branded drug or the innovator drug is the first approved
drug that meet all the required regulatory guidelines and it is
effective and safe to use.
A generic drug is developed using the same active ingredients
as of the branded drugs but some changes is done in its
development process to cut down the price and make it
affordable for the consumers without compromising with the
safety, quality and efficacy of the drug.
6

There are some basic requirements that remains same as the
branded drugs while developing a generic drug are
1.ACTIVE PHARMACEUTICAL INGREDIENTS
2.Intended use
3.Route of administration
4.Dose and strengt
7

BASIC STANDARDS SET BY US FDA FOR
GENERIC DRUG APPROVAL
• Drug manufacturers who want to commercialize a generic
medication that is identical to (or bioequivalent to) the
brand-name medication must file an ANDA to the FDA.
FDA examines the application to make sure that
pharmaceutical companies have shown that the generic
drug can be used in place of the brand-name drug that it
resembles.
• A generic medication must be similar to the brand in the
following ways, according to an ANDA:
• • The brand-name medicine/innovator drug shares the same
active ingredient of the generic drug
8

• An active ingredient is the crucial component of the drug
that treats the illness or medical condition so it should be
the same.
• The FDA must assess the scientific documentation provided
by generic drug manufacturers proving that their active
component is same to that of the name-brand drug it is
copying.
• •The strength of the generic drug is the same.
• •The medication is a similar kind of item (such as a tablet
or an injectable).
• •The medication is administered via the same route (such as
oral or topical).
9

• It has the same use indications.
• It lasts for atleast same period of time.
• It is produced in accordance with the same high standards
as name-brand drugs.
• It satisfies the same batch's identity, strength, purity, and
quality standards.
• Generic drug producers are required to create batches of the
medicines they intend to market and submit details about
their production for FDA evaluation.
• The label on the medicine is same to the label on the
branded medicine.
10

• Container that will be used to ship and sell the medication
is appropriate.
• The label is alike to that of the brand-name drug.
• The generic medication's drug information label should be
alike to the innovator drug label. If the brand-name
medication is authorized for more than one use and that use
is covered by patents or exclusivities, that use will be an
exception
11

GENERIC DRUG DEVELOPMENT PROCESS
Listed steps are required in the development of generic drugs.
12

• Characterization of Reference product
• Patent Restriction Consideration
• Design of the Generic product
• Formulation Development
• Design of the Generic product
• Formulation Development
• Pre-formulation studies
• Pharmaceutical formulation development process
• Selection of Excipients
• Identification of manufacturing process
•
13

• Some basic properties of the excipient should be-
• Chemically inert
• Economical
• Readily available
14

• BIOAVAILABILITY AND BIOEQUIVALENCE
•
• Bioequivalence- The lack of a discernible difference in the
rate and degree to which the active ingredient or active
moiety in pharmaceutical equivalents or pharmaceutical
alternatives becomes accessible at the site of drug action
when given at the same molar dose under similar
circumstances in a study with the proper design.
•
15

• Bioavailability- It is only possible to get the therapeutic
effects of any drug when the drug can be absorbed by the
body, so bioavailability is the key to making an
enhancement that delivers proven benefits. Bioavailability
of drugs indicates the percentage, amount or concentration
of drug that reaches into the systemic circulation and is
available at the site of action.
• Manufacturers are required to conduct research to ascertain
whether their product is bioequivalent to the brand-name
medication, which means that it distributes its active
ingredient (the drug) into the bloodstream nearly as
quickly and in nearly the same quantities as the brand-
name medication. Bioequivalence studies only need to
demonstrate that the generic version produces nearly the
same levels of drug in the blood over time, 16

GENERIC DRUG APPROVAL PROCESS
• FDAAPPROVAL PROCESS FOR GENERIC DRUGS
• When submitted to the FDA Center for Drug Evaluation and Research, office of
generic drugs, the abbreviated new drug application (ANDA) comprises
information that enables the approval of a generic drug product. The regulation
was developed to strike a balance between the generic and brand-name
medicine markets. It allowed for easy access to less expensive generic
medications while still supporting research and development of novel
medications. After the patent and some exclusivities expired, the generic
medicine manufacturers were permitted to offer the medication. The federal
food, drug, and cosmetics act's Hatch-Waxman amendment established the
procedure through which prospective generic drug marketers can submit an
Abbreviated New Drug Application (ANDA) to the FDA in order to request
FDA approval of their products. Companies that "first-file" an ANDA against
the owners of patents for branded counterparts are granted 180 days of
exclusivity under Act paragraph IV. The "Hatch-Waxman Act," to put it simply,
is the amendment to the Federal Food, Drug, and Cosmetics Act that created the
current mechanism for the approval of generic drugs. 17

Abbreviated New Drug
Application
• An innovator drug product that is comparable to a generic drug product
in terms of dosage form, strength, route of administration, quality,
performance characteristics, and intended use is referred to as a
reference listed drug (RLD) product and is listed in the FDA's list of
approved drug products with therapeutic equivalence evaluations
(orange book). In the event that the RLD's patent exclusivity and patent
protection have both expired, the applicant may manufacture and
distribute the generic drug product after receiving approval. Since the
safety and effectiveness of the innovator drug product—the first
approved version of the drug product marketed under a brand name—
have already been established, generic drug applications are referred to
as "abbreviated" because they are not required to provide clinical data
to support these claims.
18

19

20

21

• 1. Form 44 must be submitted for generic medicine approval in India.
2. In India, all active ingredients are
allowed for less than a year with a treasury challan of INR 50,000 and
require a treasury challan of INR 15,000 for those that are required for
more than a year. 3. Production of basic ingredients and
large-scale pharmaceuticals A copy of the applicant's manufacturing
licence for bulk medications must be provided.
22

• 4. Information about chemicals and drugs, including:
Active
ingredients information
a) Detailed Chemical and Pharmaceutical Information about
Formulation
a) Master manufacturing formula
b) Information about the formula (including inactive
ingredients)
c) Finished product specification
d) Quality control testing during process.
e) Analysis
certificate including information on contaminants, assay,
content uniformity, and pH, among other things.23

• f) When using an oral dose form, comparative dissolution
data is required.
g) Evaluation of the stability study in compliance with
Schedule Y
• 5. The drug's regulatory status and the names of the
businesses promoting it in the nation are included.
6. Bioavailability and Bioequivalence study reports (for oral
dosage forms)
7. For injectable formulations, sub-acute toxicity research
using the applicant's product is required.
8. Prescribing details
9. Draft of labels and packaging
10. Copy of License in Form-29[22]
24

THANK YOU
25

References
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NTCC REPORT PPT.ppt generic drug development and approval

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