“ DRUG RAGULATORY AFFAIRS DEPATMENT AND

PHARMACEUTICAL SCIENCE & IT'S ROLES ON DRUG

DEVELOPMENT INDUSTRY ”
A synopsis
Submitted for the Award of the Bachelor of Pharmacy Degree By
Mr. Dalchand Sahu
B. Pharma VIII Semester
Roll no.- 91012000015
Dr. C. V. Raman Institute of Pharmacy

Under the Supervisions of

Mr. Gaurishankar Birtia
(Assistant Professor)

Dr. C. V. Raman University, Kargi Road, Kota, Bilaspur (CG)

Session 2023-24
 CERTIFICATE

This is to certify that synopsis entitled "Drug Ragulatory Affairs Department and
Pharmaceutical Science & It's Role On Drug Development Industry " which is submitted
by Mr. Dalchand sahu, Roll No. - 91012000015. The partial fulfilment of award of the
degree of Bachelor of Pharmacy by Dr. C.V. Raman Institute of Pharmacy is a record of the
candidate's own work, carried out by him under my supervision and guideline. He has
collected all the literature very seriously and methodically and his work is authentic.

Place- Dr. C.V. Raman University, Kargi Road, Kota, Bilaspur (C.G.)

Date-

Supervisor

Mr. Gaurishankar Birtia

 CERTIFICATE

Its gives me immense pleasure in certifying that the project entitled “Drug Ragulatory
Affairs Department and Pharmaceutical Science & It's Role on Drug Development
Industry” carried out and submitted by Mr. Dalchand Sahu. He has completed the
requirements as per degree of Bachelor of Pharmacy regulations of the University;

I recommend the submission of synopsis as prescribed/notified by the University.

Date: - Dean/Principal
Prof. Dr. Saket Singh Chandel
 DECLARATION

I am Dalchand Sahu, hereby declare that the Project work incorporated in the present
synopsis entitled “Drug Ragulatory Affairs Department and Pharmaceutical Science &
It's Role On Drug Development Industry ” is our original work. This work (in part or in
full) has not been submitted to any University for the award or a Degree or a Diploma. I have
properly acknowledged the material collected from secondary sources wherever required.

We solely own the responsibility for the originality of the entire content.

Date: - Signature of the Candidate

Signature of the Supervisor

 ACKNOWLEDGEMENT

Heart is overwhelmed and words are few to express my deep sense of gratitude towards
“GOD” the Almighty, who was so merciful to fulfil my ever-increasing wishes and made it
possible for me to reach at this stage of life.
It will always be a matter of pride and honor to be a student of CVRU. Apart from the
education, CVRU also gave me a golden opportunity to interact with people from all parts of
the country and imbibe different cultures.
I take this privilege to express my profound gratitude to Prof. (Dr.) Saket Singh Chandel,
Principal, Dr. C.V. Raman Institute of Pharmacy, Dr. C.V. Raman University, Kargi Road,
Kota, Bilaspur (C.G.) for providing me the facilities during my course of study and
Dissertation.
I consider it as a great honor to express my heartfelt appreciation to my guide Mr.
Gaurishankar Birtia, Assistant Professor, Dr. C.V. Raman Institute of Pharmacy, Dr. C.V.
Raman University, Kargi Road, Kota, Bilaspur (C.G.) Thanks for his willingness to offer
continuous guidance, support and encouragement, which are driving forces for me to
complete this synopsis. His vast knowledge, his attitude of research and skill of presentation
have been an invaluable resource to me. He is an admirable professor and will always be a
role model for me.
It would be unwise if I forget to express my sincere thanks and gratitude to Mr.
Gaurishankar Birtia (Assistant Professor)
The successful completion of my report is an ecstatic moment in my student life. I take this
opportunity to express my gratitude to all the individuals who are directly or indirectly
involved in the successful completion of my work.
It would be unfair if I don’t thank my father, mother and all my family members for their
blessings and everlasting encouragement throughout my work. Without their constant
support it would not have been possible for me to complete my work. I sincerely thank each
and every one who stood my side and made this work possible.
Name – Dalchand Sahu
Roll no. – 91012000015
Dr. C.V. Raman Institute of Pharmacy,
Dr. C.V. Raman University, Kargi Road Kota, Bilaspur (C.G.)
 INDEX

S. No. TOPIC PAGE No.

01. ABSTRACT 1
02. INTRODUCTION 2
03. LITERATURE SURVEY 4
04. AIM AND OBJECTIVE 5
05. METHOD 6
06. RESULT DISCUSSION 7
07. FUTURE PROSPECTS 7
08. CONCLUSION 8
09. REFERENCE 9
 ABSTRACT

The Indian pharmaceutical industry is increasing quickly, and there is a need of regulatory
affairs professionals to meet the present demands of companies in the face of worldwide
competition. A regulatory affair is a rather younger career that emerged from governments'
efforts to guard public health. Pharmaceuticals, veterinary medications, clinical gadgets,
insecticides, agrochemicals, cosmetics, and complementary treatment options are examples of
industries the place government regulates the protection and effectiveness of products. The
pharmaceutical organizations in charge of the development, testing, scientific trials,
production, manufacturing, and marketing of these drug treatments additionally prefer to
assurance that the gadgets they offer are tightly closed and contribute meaningfully to the
health and welfare of the conventional population. The international regulatory authorities
and the pharmaceutical enterprise are related with the aid of regulatory affairs specialists.
They should be well-versed in the laws, rules, directives, and regulations of the regulating
bodies. To better prepare college students for careers in the pharmaceutical industry, it is
turning into more and more integral to include the most current developments in the popular
curriculum of pharmacy colleges. The current article examines the necessity for regulatory
education, educational resources, handy courses, path material, and employment possibilities
in regulatory affairs.

KEY WORDS: (regulatory affairs , FDA,IND,TGA,Drug regulatory bodies)

 INTRODUCTION

As the pharmaceutical industries around the world advance towards becoming greater and
extra competitive, these sectors are realizing that the actual fighting of survival lies in
carrying out the work via comprehending the recommendations related to a number activities
carried out to grant an assurance that the process is under regulation. Being one of the
fantastically regulated businesses, the pharmaceutical enterprise is in increased demand than
ever of humans who are in a position to manage difficulties concerning to regulatory affairs
in a complete manner. The discipline of regulatory affairs (RA), frequently known as
government affairs, is located in regulated organizations like banking, pharmaceuticals,
scientific devices, and energy. Within the healthcare sectors (pharmaceuticals, medical
devices, biologics, and practical foods), a regulatory affair (RA) also has a rather unique
definition. The majority of businesses, whether they are large, world pharmaceutical firms or
start-up, innovative biotechnology businesses, have specialised regulatory affairs (RA)
departments. The effectiveness of a regulatory method is less reliant on the policies than it is
on how they are interpreted, put into practice, and communicated to inside stakeholders and
external stakeholders. Figure 1 displays the numerous features of the DRA department.
Professionals in pharmaceutical regulatory affairs play a necessary position , in making sure
that all pharmaceutical objects adhere to regulations that control the sector.
Pharma regulatory affairs gurus ensure that all operations and products fulfill the essential
security and efficacy necessities at some stage in the licensing and advertising and marketing
stages as properly as all through the initial utility segment for a new or universal drug. To
check whether or not rules are being followed
 LITERATURE SURVEY

• In 2008, bloked FDA import of genetic drugs from India's Ranbaxy Laboratory's,
based on regulatory comliance issuies involving two plant's Dewas and another in
paonta sahib. Specifically. FDA inspections earlier in 2008 revealed violarions that
could result in formulation problems and therefore instructed the company to take
steps toward resolving the issues, Ranbaxy field to do. The company makes generic
versions of much used drugs like Zocor. Which physician prescribed to treat
antibiotics.
• In 2009,Another FDA import ban came. Apotex canada's biggest drug maker ,saw its
product stopped at the U.S. after a plant inspection identified deviations from
manufacturing rules. Problems at Apotex Etoboke facility were detailed in a warning
letter, which contended that Apotex did not throughly investigate its own
manufacturing failures and that anunusual number of batches ended up reejected. The
import ban affected a number of a drugs made a two plants, mostly older
product .Apotex said it is '' actively working with the FDA ti resolve'' product from
entering the U.S.
• In 2013, wochadt Ltd faced a sharp drop in market share and delays in new launch
approvals after a second plant operated by the generic drug maker was hit by the US
food and Drug Administration ''import alert'', effectively a ban. An resilts in the
detention without physical examination of drugs from firms that have not met so
called good manufacturing practices ,acorrding to the FDA website .the latest FDA
action regulatory rebukes in recent months, which has wipped off nearly valus this
year.
• In 2014, The US Food and Drug administration [FDA] Warned privently owned drug
maker Cadila pharmaceuticals Ltd that it was not following quality and manufacturing
standards at one of its plants, which caused impurities in drug ingredients made there.
In a warning letter posted on its websites, the FDA said inspectors has found ''
significant deviations'' from standard manufacturing practices at cadila
pharmaceuticals' Ankeshwar plant in gujrat state. The FDA issued the letter ,and gave
the company 15 days to respond. If cadila pharmaceuticals fails to take measures to
correct the united State from the plant
 AIM
Drug Regulatory Affairs Department and Pharmaceuticals Science & It's Role On Drug
Development Industy.

OBJECTIVES
1. To determine whether a regulatory function exists, how it is carried out and What
financial and human resources are available for its implemention.
2. To identify the strengths and weakness of drug regulation.
3. To propose strategies that can help policy-makers and implementers to imrove drug
regulation.
4. To map the legall and organizational structures of drug regulation in selected
countries.
 PLAN OF WORK

1. Pharmaceuticals regulatory affairs and its importance

2. Regulatory department and professionals
3. Different important regulatory act
4. A comparative studt on Drug Regulatory bodies in India US, European Union [EU]
and Japan
5. Explanation of some important terns in regulatory affairs.

MATHOD

• The Drug Development and Regulatory Affairs in USA, EUROPE And INDIA.
• Evaluation of MAA {Marketing Authorization Application}
• Support to Pharmaceuticals Manufactures
• Drug Safety and Efficacy
• Drug and Cosmetics.
• Food and Drug Administration {FDA}
• Investigation New Drug Application {INDA}
• New Drug Application {NDA}
• Abbreviated New Drug Application {ANDA}
• Active Pharmaceuticals Ingredient {API}
 RESULT AND DISCUSSION

The F.D.A. [ Food and Dug Administration} is the main regulatory body governing and
implementing the rules and regulations for the Drug & Pharma industry.The F.D.A. has state
branches and sub-branches all over the country.With globlization process reaching out to
india, the geographical barrier have become obsolete. Any country will have to compete and
trade globally in order to progress and servive in the year to come. The major drugs and
pharma companies have realized fact and have stepped into the global area of competitive
trade. If an indian manufacturer wants to sell his drugs or formulations to a foreign country it
is mandatory that he has to fullfill all the statory requirement laid by the regulatories of that
country. Also his product needs to be perfectly as per the specifications countries and ICH
guidelines going to be uniform for international level.
Since the business involved is worth tremendous significance and is bound to grow
enormously. Many big player in the drugs &pharma field has already established seperate
Regulatory Affairs Department in their companies. The field is professional the need for
further reseach and clinical trials would provide a comprehensive results discussion for your
project.
 FUTURE PROJECTS

Regulatory Affairs is a unique mix-up of science and management to achieve a commercially

important goal within a drug- Development organization. It touches everything relating to
drugs from the earliest through development, into routine manufacture and marketing. It can
add significant impact for patients and drug companies. It is one of the dynamic and help to
protect public health by constant monitoing and controlling the safety and efficacy of
Pharmaceuticals Regulatory Affairs in the Pharma industry may be Regulatory bodies.
 CONCLUSION

The new approach to regulation, according to the Regulatory Affairs profession, will
ultimately be embraced for all healthcare objects considering it affords the nice method for
bringing new drugs medical advancements to market in a well timed manner while retaining
proper safety. The majority of businesses, whether they are large, multinational
pharmaceutical corporations or small, creative biotechnology companies, have specialised
regulatory affairs departments with regulatory affairs professionals.

This department is constantly evolving and is the one that is least affected with the aid of
mergers and acquisitions as properly as monetary downturns. Some agencies additionally
decide to outsource or delegate regulatory matters to outside service companies due to the
transferring resources required to satisfy regulatory standards. The shortening of the time it
takes for a product to reach the market is quintessential to its success and the success of the
company in the modern-day competitive environment. The successful execution of the
company's Regulatory Affairs things to do is hence vital to its economic health.
 REFERENCE

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the Pharmaceutical Industry; Asian Journal of Pharmaceutical Technology & Innovation,
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Research in Pharmaceutical & Bio Sciences, 2012; 2(2): 292-301.
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International Journal of Research and Development in Pharmacy and Life Sciences, 2013;
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