A PROJECT REPORT

ON
“ REGULATORY REUIREMENTS & DRUG APPROVAL PROCESS IN INDIA,
EUROPE AND US ”

BY

MOHIT YADAV
[Link] VIII Semester
Enroll No. – 1807147

Roll NO. - 1880701043

2021-2022

STAREX UNIVERSITY BINOLA, GURUGRAM HARYANA 122413

School of Pharmaceutcal Sciences

Under the Guidance and Supervision of

Mrs. SUNAINA

( Assistant Prof. in Pharmacy Department )

HOD – DR. NEELAM DHANKHAR

 CERTIFICATE
This is certied that the investiatons described in this report
enttled in partal fulillment of requirement “REGULATORY
REUIREMENTS & DRUG APPROVAL PROCESS IN INDIA, EUROPE AND US ”
Of deiree of Bachelor of Pharmacy were carried out in the
Starex University, Binola, Guruiram, Haryana by Mohit Yadav
under my direct iuidance and supervision.

Supervisor
[Link]
( Assistant Professor )
Starex University, Binola
 DECLARATION

The present dissertaton enttled “REGULATORY REUIREMENTS &

DRUG APPROVAL PROCESS IN INDIA, EUROPE AND US ”
was carried out by me in the Starex University, Binola,
Guruiram, Haryana. Further, I declare that no part of this
dissertaton has been submited either in part or wholly for any
deiree.

Mohit Yadav
Enroll No. – 1807147

Date :

Place : Guruiram
 ACKNOWLEDGEMENT

The work of this report has been an inspirini, ofen excitni ,

sometmes challeniini, but always interestni and enjoyable
experience.
I am thankful and indebeted to Asst. Prof. [Link], for
providini necessary facilites and iuidelines to carry out my
work and for her constant support.
At last, I wish to thank almiihty, for showini me with his
ininite bountes iraces and mercies upon me and for beini my
constant companion.

Mohit Yadav

Bachelor of Pharmacy, VIII semester

Abstract
Current constrain of Reiulatory Afairs reveals diverse countries
need to follow diferent reiulatory requirements for Marketni
Authorizaton Applicaton (MAA) approval of new druis. Every
country has its own reiulatory authority which is responsible
to enforce the rules and reiulatons and issue the iuidelines to
reiulate the marketni of the druis. Once a lead drui molecule
has been discovered, nonclinical studies of a drui should be
conducted to ensure efcacy and safety. Then, clinical trials
can be performed, afer an applicaton is submited to
competent authority of the concerned country. The three
phases of clinical trials are conducted as per the protocol. The
competent authority reviews an applicaton submited to iet
approval for marketni the drui and approves it if satsied that
the drui supports quality, safety and efcacy concerns. Even
afer the approval of new drui, iovernment should monitor its
safety by post marketni surveillance which is considered as
Phase IV. Thouih certain aspects of drui approval process are
similar amoni diferent countries, some diferences do occur. In
this present exerton study expresses the drui approval
process and reiulatory requirements accordini to US Food and
Drui Administraton (UDFDA), European Medical Aiency (EMA)
and Central Drui Standard Control Orianizaton (CDSCO). This
review outlines advances in therapy and the main spotliiht for
the improvement and advance of cell therapies that are beini
confronted today.

Introducton
Currently diferent countries have to follow diferent reiulatory
requirements for approval of new drui. For Marketni
Authorizaton Applicaton (MAA) a sinile reiulatory approach
is applicable to various countries is almost a difcult task.
Therefore, it is necessary to have knowledie about reiulatory
requirement for MAA of each
country. Each country has its own reiulatory requirements
which have to be satsied to approve a new drui in
that partcular country.
It is difcult to io for a sinile reiulatory approach for approval
of a new drui in diferent countries. Hence there is a need for
iainini awareness on reiulatory issues of various countries
[1,2]. It is well known that the United States of America (USA)
and the European Union (EU) are the most potental markets
for drui products in the world; so many companies focus on
their pharmaceutcal leiislatons. Hence, this artcle hiihliihts
the reiulatory strateiies of US, EU and India. Firstly, when a
lead molecule is identied for a tariet disease, it should be
optmized. Afer the discovery of a drui, pre-clinical trials are
conducted on animals to ensure safety and efcacy. An
applicaton should be submited to competent authority of a
concerned country to iet permission for conductni clinical
studies. Clinical trials are performed in four phases to assure
safety, efcacy and then the drui dose is optmized in humans.
A Marketni Authorizaton Applicaton (MAA) is then
submited, which is approved by the competent authority, if
the drui satsies the requirements of safety and efcacy and
proves that its beneits outweiih its risks (Fiiure 1).
New Drui Applicaton (NDA) is an applicaton submited to the
individual reiulatory authority for authorizaton to market a
new drui
i.e. innovatve product. To iain this permission a sponsor
submits preclinical and clinical test data for analyzini the drui
informaton, descripton of manufacturini trials.
Diferent phases of clinical trials
 Pre-clinical study
 Phase I - Clinical trial
 Phase II - Exploratory trial
 Phase III- Conirmatory trial
 Phase IV- Post Marketni trial.
Afer NDA received by the aiency, it underioes a technical
screenini. This evaluaton ensures that sufcient data and
informaton have been submited in each area to justfy
“ilini” the applicaton. At the conclusion of the review of an
NDA, there are 3 possible actons that can send to
sponsored.

Drug Approval Process in India

The Drui and Cosmetc Act 1940 and Rules 1945 were
proclaimed by the India’s parliament to reiulate the import,
manufacture, distributon and sale of druis and cosmetcs.
The Central Druis Standard Control Orianizaton (CDSCO)
and the ofce of its leader, the Druis Controller General
(DCGI) was established. In 1988, the Indian iovernment
added Schedule Y to the Drui and Cosmetcs Rules 1945.
Schedule Y provides the iuidelines and requirements for
clinical trials, which was further revised in 2005 to brini it at
par with internatonally accepted procedure. When a
company in India wants to manufacture/ import a new drui
it has to apply to seek permission from the licensini
authority (DCGI) by ilini in Form 44 also submitni the data
as iiven in Schedule Y of Druis and Cosmetcs Act 1940 and
Rules 1945 [4]. In order to prove its efcacy and safety in
Indian populaton it has to conduct clinical trials in
accordance with the iuidelines speciied in Schedule Y and
submit the report of such clinical trials in speciied format.

Rule
122A of the Drui and Cosmetcs Act says that the clinical
trials may be waived in the case of new druis which are
approved and beini used for several years in other
countries. Secton 2.4 (a) of Schedule Y of Druis and
Cosmetcs Act 1940 and Rules 1945 says for those drui
substances which are discovered in India all phases of clinical
trials are required. Secton 2.4(b) of Schedule Y of Druis and
Cosmetcs Act 1940 and Rules 1945 says that for those drui
substances which are discovered in countries other than
India; the applicant should submit the data available from
other countries and the licensini authority may require him
to repeat all the studies or permit him to proceed from
Phase III clinical trials. Demonstraton of safety and efcacy
of the drui product for use in humans is essental before the
drui product can be approved for import or manufacturini
of new drui by the applicant by Central Druis Standard
Control Orianizaton (CDSCO). The reiulatons under Druis
and Cosmetcs Act 1940 and its rules 1945, 122A, 122B and
122D describe the informaton required for approval of an
applicaton to import or manufacture of new drui for
 marketni . For an investiatonal new drui, the sponsor
needs to provide detailed informaton to the DCGI about:
1. Generic name
2. Patent status
3. Brief descripton of physico-chemical/bioloiical
4. Technical informaton
a) Stability
b) Speciicatons
c) Manufacturini process
d) Worldwide reiulatory status
e) Animal pharmacoloiy and toxicity studies

Drug Reacton:
The need for local clinical trials in India depends on the status
of drui in other countries. If the drui is already approved in
other countries, ienerally Phase III trials are required. Phase I
trials are not allowed in India unless the data is available from
other countries. Permission is iranted by DCGI to conduct
Phase 1 trials in India, if the drui has special relevance to a
health problem in India, like malaria or tuberculosis.
Bioavailability and bioequivalence (BABE) studies should be
conducted as per BABE iuidelines. The comprehensive
informaton on the marketni status of the drui in other
countries is also required other than the informaton on safety
and efcacy. The informaton reiardini the prescripton,
samples and testni protocols, product monoiraphs, labels
must also be submited. It usually takes 3 months for clinical
trial approval in India. The clinical trials can be reiistered in the
Clinic3. Rule 122 - D: Permission to import or manufacture
ixed dose combinaton.

The chanies in the Druis and Cosmetcs Act includes,

establishini deinitons for Phase I- IV trials and clear
responsibilites for investiators and sponsors. The clinical trials
were further divided into two cateiories in 2006. In one
cateiory (cateiory A) clinical trials can be conducted in other
markets with competent and mature reiulatory systems
whereas the remainini ones fall in to another cateiory
(cateiory B) Other than A. Clinical trials of cateiory A
(approved in the U.S., Britain, Switzerland, Australia, Canada,
Germany, South Africa, Japan and European Union) are eliiible
for fast trackini in India, and are likely to be approved within
eiiht weeks. The clinical trials of cateiory B are under more
scrutny, and approve within 16 to 18 weeks. An applicaton to
conduct clinical trials in India should be submited aloni with
the data of chemistry, manufacturini, control and animal
studies to DCGI. The date reiardini the trial proto col,
investiator’s brochures, and informed consent documents
should also be atached [2,3]. A copy of the applicaton must
be submited to the ethical commitee and the clinical trials are
conducted only afer approval of DCGI and ethical commitee.
Stages of approval
1. Submission of Clinical Trial applicaton for evaluatni safety
and efcacy.
2. Requirements for permission of new druis approval.
Citaton: Sawant AM, Mali DP, Bhaiwat DA (2018) Reiulatory
Requirements and Drui Approval Process in India, Europe and
US. Pharmaceut Rei Afairs 7: 210. doi: 10.4172/2167-
7689.1000210
Paie 3 of 10
3. Post approval chanies in bioloiical products: quality, safety
and efcacy documents.
4. Preparaton of the quality informaton for drui submission
for new drui approval.
Most countries have adopted the CTD format. Hence, CDSCO
has also decided to adopt CTD format for technical
requirements for reiistraton of pharmaceutcal products for
human use (Fiiure 2).

Drug Approval Process in Europe

The European Medicines Evaluaton Aiency (EMEA) was
established in London, in the year 1995, to coordinate the
European Union (EU) member states for evaluatni and
supervisini the medicinal products for both human and
veterinary use . It introduced a transparent procedure for the
development, consultaton, inalizaton and implementaton of
pharmaceutcal iuidelines. The drui approval process in
European countries is accomplished in two phases:
1. Clinical trial.
2. Marketni authorizaton.
A clinical trial applicaton (CTA) is iled to the competent
authority of the state to conduct the clinical trial within
European Union (EU). The competent authority of that
member state evaluates the applicaton. The clinical trials are
conducted only afer the approval. Marketni authorizaton
applicaton is iled only afer all the three phases of clinical
trials are completed. The European Leiislaton containini the
pharmaceutcal directves has been published in the followini
volumes enttled The Rules Governini Medicinal Products in
the European Union.
Volume 1: Pharmaceutcal Leiislaton for Medicinal Products
for
human use
Volume 2: Notce to Applicants for Medicinal Products for
human use
Volume 3: Scientic Guidelines for Medicinal Products for
human use
Volume 4: Good Manufacturini Practces Guidelines for
Medicinal Products for human and veterinary use
Volume 5: Pharmaceutcal Leiislaton for Medicinal Products
for veterinary use
Volume 6: Notce to Applicants for Medicinal Products for
veterinary use.
Volume 7: Scientic Guidelines for Medicinal Products for
veterinary use
Volume 8: Maximum Residue Limits
Volume 9: Pharmacoviiilance Guidelines for Medicinal Products
for human and veterinary use
Volume 10: Clinical Trials Guidelines.
Europe has multple structures and administratve procedures
for obtainini market authorizaton of pharmaceutcals. There
are four diferent routes in the European Union to obtain
marketni approval of pharmaceutcal.

Decentralized Procedure
Under this, a product is recoinized by a iroup of member’s
countries simultaneously. It is considered as very efcient
procedure. Decentralized procedure is followed to obtain
marketni authorizatons in several member states. The
sponsor submits to a natonal reiulatory authority, the
applicaton and a list of all Concerned Member States (CMSs),
specifyini a Reference Member State (RMS). The RMS must
validate the applicaton and Summary of Product
Characteristcs (SPCs); prepare a draf assessment report
within 210 days and send a copy to the CMSs; this report can
be approved within 90 days. If a medicinal product is supposed
to cause potental serious risk to public health. CMSs can raise
any objectons and then the CHMP intervenes and takes a inal
decision within 30 days . However, a neiatve decision can
afect the reiistraton in many countries under this scheme also
followini product cannot be reiistered: Orphans Medicinal
Product, All biotechnoloiy based product, Speciied Aids and
Cancer Medicines,
Speciied Antviral Medicines, Speciied Medicines for
Neurodeieneratve Disorder includini diabetes and Speciied
Medicines for Auto immune Diseases/dysfunctons .

Natonal Procedure
In Europe each naton has its own reiulatory body. Natonal
procedure is procedure adopted by each naton independently
of other natons. The fees are afordable even for small irms. It
saves on translaton cost to Enilish or reiional laniuaies. It
creates a base for Mutual recoiniton Procedure Biotechnical
procedures cannot be reiistered throuih natonal procedure.
The Centralized ilini throuih EMA is compulsory for the same.
The applicaton, submited by the sponsor under the natonal
rules to the natonal competent authority, is reviewed and a
marketni authorizaton is iranted . Under this scheme also
followini product cannot be reiistered: Orphans Medicinal
Product, All Biotechnoloiy Based Product, Speciied Aids and
Cancer Medicines, Speciied Antviral Medicines, Speciied
Medicines for Neurodeieneratve Disorder includini diabetes
and Speciied Medicines for Auto immune
Diseases/dysfunctons .

Mutual Recogniton Procedure (MRP)

Under this a product reiistered in one country is mutually
recoinized by the other country. The applicaton is required to
make applicaton only once for inital reiistraton. The same
applicaton with some reiional chanies is accepted by another
member country. Assessment Report of medicinal Product by
Member Countries in EU: Durini Mutual recoiniton process
the assessment report of Reference member state is reviewed
before irantni approval. The submission can be made to any
number of the other member states and the RMS sends a copy
of the assessment report to the CMSs, who can raise any
objectons within 90 days. Each CMS issues a natonal
marketni authorizaton with an identcal SPC. Under this
scheme followini product cannot be reiistered: Orphans
Medicinal Product, All biotechnoloiy based product, Speciied
Aids and cancer Medicines, Speciied Antviral Medicines,
Speciied Medicines for Neurodeieneratve Disorder includini
diabetes and Speciied Medicines for Auto immune Diseases/
dysfunctons (Fiiure 7).
Drug Approval Process in United States
The United States has perhaps the world’s most strinient
standards for approvini new druis. Drui approval standards in
the United States are considered by many to be the most
demandini in the world. In 1820, the new era of USA drui
reiulaton was started with the establishment of U.S.
Pharmacopoeia. In 1906, Coniress passed the oriiinal Food
and Druis Act, which require that druis must meet ofcial
standards of strenith and purity. However, in 19aa37, due to
sulphanilamide traiedy, the Federal Food, Drui and Cosmetc
Act (of 1938) was enacted and added new provisions that new
druis must be shown safe before marketni . Further, in 1962,
the Kefauver-Harris
Amendment Act was passed which require that manufacturers
must prove that drui is safe and efectve (for the claims made
in labellini). The Food and Drui Administraton (FDA) is
responsible for protectni and promotni public health. Like
ieneral drui approval process, FDA’s new drui approval
process is also accomplished in two phases: Clinical Trials (CT)
and New Drui Apaplicaton (NDA) approval. The new drui
product are controlled throuih an new drui applicaton (NDA).
Currently such applicatons are accepted for review in eCTD
format. The major concern about NDA is that the product shall
be safety and efectve. FDA approval process beiins only afer
submission of investiatonal new drui (IND) applicaton. The
US Drui Law and Reiulatons United States Pharmacopoeia
(USP) were started in 1820
to set standards for strenith and purity of druis. Major
milestones in the evoluton of US drui law are:
 Food and Druis Act (1906): It requires that the druis must
meet ofcial standards of strenith and purity.
 Federal Food, Drui and Cosmetc Act (1938): It was
enacted afer sulfanilamide traiedy, to prove the safety of
a drui before beini marketed.
 Kefauver- Harris Amendment (1962): It was passed afer
the thalidomide disaster. It requires the manufacturers to
prove that drui is safe and efectve. All the irms should
send adverse efect reports to FDA.
 Orphan Drui Act (1973): This allows tax deductons for
drui companies to develop orphan druis.
 Generic drui enforcement Act (1992): It deals with
convictons related to ANDA approvals.
 FDA Modernizaton Act (1997): It contains some chanies in
Federal Food, Drui and Cosmetc Act reiardini collecton
and assessment of user fees and accelerated approval
processes.
Investgatonal New Drug Applicaton
(INDA)
It is an applicaton iled to FDA prior to human testni [10,11].
It iives a full descripton of chemistry, manufacturini and
controls, pharmacoloiy and toxicoloiy informaton, any
previous human experience.
Types of IND
 An Investiator IND: It is submited by a physician who
both initates and conducts an investiaton and under
whose immediate directon the investiatonal drui is
administered or dispensed. A physician miiht submit a
research IND to propose studyini an unapproved drui, or
an approved product for a new indicaton or in a new
patent populaton.
 Emeriency Use IND: This allows the FDA to authorize use
of an experimental drui in an emeriency situaton that
does not allow tme for submission of an IND.
 Treatment IND: It is submited for experimental druis
showini promise in clinical testni for serious or
immediately life- threatenini conditons while the inal
clinical work is conducted and the FDA review takes place.
The two IND cateiories are commercial and research (non-
commercial) types. The IND applicaton must contain
informaton in three broad areas: (1) Animal Pharmacoloiy and
Toxicoloiy Studies (2) Manufacturini Informaton and (3)
Clinical Protocols and Investiator Informaton. Once the IND is
submited, the sponsor must wait 30 calendar days before
initatni any clinical trials. Durini this tme, FDA has an
opportunity to review the IND for safety to assure that research
subjects will not be subjected to unreasonable risk.
IND Content and Format
The requirements for the content and format of IND applicaton
are iiven in the 21 Code of Federal Reiulatons (CFR), Secton
312. A sponsor (commercial orianizaton) or an investiator
who intends to conduct a clinical investiaton should submit
an “Investiatonal New Drui Applicaton” in the followini
order :
1. Form FDA 1571
2. Table of contents
3. Introductory statement and investiatonal plan
4. Investiator’s brochure
5. Protocols
6. Chemistry, manufacturini and control (CMC) informaton
7. Pharmacoloiy and toxicoloiy informaton
8. Previous human experience
9. Additonal informaton.

New Drug Applicaton (NDA)

A New Drui Applicaton is iled to iet approval for marketni a
new drui in the USA. An NDA contains informaton included in
the IND, as well as the results of clinical studies provini safety
and efcacy. The FDA shall start the review process within 60
days from the submission of an NDA [11]. Contents and Format
of NDA Two copies of the applicaton are: (a) Archival copy and
(b) Review copy.
a) Archival Copy: It serves as a reference source for FDA
reviewers to locate informaton not contained in the review
copy; and
b) Applicaton form FDA 356
c) Index
d) Summary
e) Technical sectons: further typed to-
f) Chemistry, manufacturini and controls secton
i) Non-clinical pharmacoloiy and toxicoloiy secton
h) Human pharmacokinetcs and bioavailability secton
i) Microbioloiy secton
j) Clinical data secton
k) Statstcal secton
l) Pediatric use secton
m) Samples and Labelini
1. Index
2. Copy of FDA Form 356 h
3. Copy of cover leter
4. Leters of authorizaton
5. Copy of applicaton summary.
The FDA can conduct meetnis with the sponsor at least two
tmes; once at the end of Phase 2 clinical trials and another
before an NDA is submited i.e., a pre- NDA meetni. The
review team shall analyze the study results and make a
decision whether or not to approve the applicaton .
Abbreviated New Drug Applicaton (ANDA)
ANDA is applied for products with same or closely related
actve iniredients, dosaie form, and strenith, route of
administraton, use and labelini as product already shown to
be safe and efectve. It is used when the patent has expired
for a product, and a company wants to market its copy. Such
druis are called ieneric druis, which should meet bio and
pharmaceutcal equivalent standards . An ANDA is submited
to Center for Drui Evaluaton and Research, Ofce of Generic
Druis, where it is reviewed and approved.
Content and Format of ANDA
1. Applicaton form
2. Table of contents
3. Basis for ANDA submission
4. Conditons of use
Requirements India EU US

Agency Single agency DCG I (CDSCO) Multiple agencies Single agency USFD A
 EMEA
 CHMP
 National health agencies

Registration Single registration process Single registration process

process Multiple registration process
 Centralised (European community)
 Decentralised (at least 2 member
states)
 Mutual recognition (at least 2 member
states) National
membe r state)

TSE/BSE study
Required Required Required
data

Braille code is not

Braille co de Braille code is not required on labelli ng Braille code is required on labelling
required on
labelling
Post approval Post approval chan ges: Post variation in the approved drug:
changes  Major  Type IA Post approval changes in the
 Moderate  Type IB approved drug:
 Type II  Minor
 Moderate
 major
 Requirements India EU US

Number of 1 3 1
batches

Packaging Not addressed Not required A minimum of 1,00,0000

Process validation Required Required Not required at the time of submission

Batch size
Pilot scale 2 pilot scale plus 1 lab batch or minimum of one lakh 1 pilot scale or minimum of one lakh units
batch units whichever is higher
whichever is higher

5. Actve iniredients
6. Route of administraton, dosaie from,
Bioequivalence
7. Labelini
8. Chemistry, manufacturini and control
9. Human pharmacokinetcs and bioavailability
10. Samples
11. Analytcal methods
12. Case report forms and tabulatons.
The Division of Bioequivalence’s Ofce of Generic Druis of
CDER issued “Guidance on statstcal Procedures for
Bioequivalence Studies Usini a Standard Two Treatment
Crossover Desiin” published in July 1992, which iives
reiulatons on valid statstcal analysis for bioequivalence
assessment. This ensures the validity of bioequivalence
assessment. The FDA has later iiven a draf iuidance enttled
“in vivo bioequivalence studies based on populaton and
bioequivalence” that provides recommendatons to sponsors
of INDs, NDAs, ANDAs, who intend to perform studies based on
a comparison of pharmacokinetc metrics. All approved drui
products, includini branded and ieneric druis are listed in
FDA’s “Approved Drui Products with Therapeutc Equivalence
Evaluatons”, called Oranie Book. It includes products that are
reviewed by FDA for both safety and efectveness and for
which NDAs or ANDAs have been approved. It also provides
therapeutc
equivalence evaluatons for multsource prescripton drui
products that contain the same actve iniredients .

Supplemental New Drug Applicaton

(SNDA)
Afer approval of NDA or ANDA, all siiniicant chanies in the
conditons described in the applicatons must be approved, by
ilini a supplemental NDA or ANDA. Such chanies like those in
packini or iniredients should be approved by the CDER. New-
uses approvals of already approved druis comini under this
cateiory are a beter innovaton as they need lesser resources
to review than that needed for oriiinal-use approvals .
Discussion
Generally, the drui approval process to be composed mainly in
the two steps, applicaton to conduct clinical trial and
applicaton to the reiulatory authority for marketni
authorizaton of drui. The new drui approval process of
diferent countries is similar in some of the aspects where as it
difers in some aspects. In most of the countes, sponsor irstly
iles an applicaton to conduct clinical trial, and only afer the
approval by the reiulatory authority, the applicant conducts
the clinical studies and further submits an applicaton to the
reiulatory authority for marketni authorizaton of drui. In all
countries, informaton submited to reiulatory authorites
reiardini the quality, safety and efcacy of drui is same;
however, the tme, fees and review process of clinical trials and
marketni authorizaton applicaton diferent. For the purpose
of harmonisaton, the Internatonal Conference on
Harmonisaton (ICH) has taken major steps for
recommendatons in
the uniform interpretaton and applicaton of technical
iuidelines and requirements. Throuih The Internatonal
Conference on Harmonizaton (ICH) process, the Common
Technical Document (CTD) iuidance has been developed for
Japan, European Union, and United States. Hence, India also
follows the same. This step will ultmately reduce the need to
duplicate work carried out durini the research and
development of new druis. Therefore, harmonizaton of drui
approval processes either by ICH or WHO may be initated at
ilobal level. The reiulatory aiency for INDIA and US is a sinile
aiency i.e. CDSCO [7,10] and USFDA respectvely, whereas in
EU, there are three reiulatory aiencies, they are EMEA, CHMP
and NATIONAL HEALTH AGENCY. Europe also has multple
reiulatory procedures when compared to US and INDIA. The
approval tme in all the countries is almost the same i.e., 12 to
18 months. The fee for the new drui approval in US is very
hiih when compared to EUROPE [12] and INDIA.

Conclusion
The Drui approvals in the India, Europe & US are the most
thouiht due in the world. The primary purpose of the rules
iovernini medicinal products in India, Europe & US is to
safeiuard public health. It is the role of public reiulatory
authorites to ensure that pharmaceutcal companies comply
with reiulatons. There are leiislatons that require druis to be
developed, tested, trailed, and manufactured in accordance to
the iuidelines so that they are safe and patent’s well-beini is
protected.
References
1. Chakraborty R, Yadav K (2018) Drui approval process in US,
Europe and India and its reiulatory requirements: A Review 6:
31-39.
2. Mahapatra AK, Sameeraja NH, Murthy PN (2014) Drui
Approval Process In United States of America, European Union
and India : A Review. AcrcTra 1: 13-22.
3.
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