This document discusses the development of Synriam, India's first homegrown anti-malarial drug developed by Ranbaxy Laboratories. The drug development project began with the goal of creating an affordable oral fixed-dose combination of arterolane maleate and piperaquine phosphate to treat Plasmodium falciparum and Plasmodium vivax malaria. Ranbaxy conducted clinical trials in India and received regulatory approval to manufacture and market Synriam for uncomplicated malaria in adults. On April 25, 2012, Ranbaxy launched Synriam in India, marking a milestone in domestic pharmaceutical research and development. The document outlines the multi-stage drug development and project management process required to bring a new drug to market

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By : DARAIN HAQUE
Guided by : AJAY WAGH SIR
SPTM,NMIMS
SHIRPUR
Project Management : A
Case Study On Synriam

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CONTENTS
1. Pharmaceutical research and development
2. Why pharmaceutical project development ?
3. Need of new drugs
4. Project management steps in new drug discovery
and development
5. Synriam – India’s first homegrown drug by Ranbaxy
6. Conclusion
7. References

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Pharmaceutical Research and
Development
Definition
• The process of discovering,developing and bringing to the
market new ethical drug products
Goal of new drug
development
project
• To develop an oral fixed-dose combination product for P.
falciparum and P. vivax malaria (adult & pediatric)
• Should show activity against resistant parasites
• Should have low propensity for development of resistance
• Effective vis-à-vis current benchmarks
• Convenient dosing: once daily for 3 days
• Affordable
• Easily available

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Why pharmaceutical project development ?
The course of drug development is unpredictable and
therefore it is important to have realistic expectations for
any given project.
There are inherent difficulties in running a drug
development programme and the larger the project the
more numerous the potential problems are.
Accounting for the factors that can stand in the way of a
project’s success and being able to take an objective
view of the strategies required is demanding,but a
necessary task.

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SYNRIAM – India’s First Homegrown Drug By
Ranbaxy
* Price : Rs. 130 for three tablets, three-day course.
* Alternative therapies require a 2-4 tablet dosage per day.
* Conforms to the recommendations of the World Health Organization
(WHO) ,Patent Publication number - WO2013008218 A1
* An estimated $30 million invested in the research and
development of this drug,the Department Of Science and Technology
has put Rs. 5 crore into the project.
* Treatment of uncomplicated Plasmodium falciparum (in adults),
which accounts for 50 per cent of malaria cases in India.
* Launched in India for uncomplicated P.falciparum malaria on 25th
April 2012.

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Arterolane,discovered by a collaborative drug discovery project
funded by the Medicines for Malaria Venture (MMV), a Swiss charity.
When it was discovered back in 2003, MMV partnered with Ranbaxy
to carry the development through to the clinic. However, after MMV
reviewed clinical trial data it backed out from developing the drug
further to focus on a derivative of arterolane, which it believed
would provide a single-dose treatment for malaria.
The price of developing a drug from scratch - big challenge for
Indian pharma because the drug discovery process incurs huge R&D
costs and has very low rates of success.

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PROGRAM GOALS
* The new drug development project began with the goal of
developing an oral fixed dose combination product for
P.falciparum and P.vivax malaria.
*Desired properties :
i. The drug should show activity against resistant parasites,
ii. have low propensity for resistance development,
iii. be effective as per current benchmarks and
iv. be affordable and easily available

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KEY INGREDIENTS
* ARTEROLANE MALEATE :
Totally synthetic
Inexpensive
Rapidly acting drug
* PIPERAQUINE PHOSPHATE :
Proven effectiveness
Established safety profile
Cost effective

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* DEVELOPMENT PATH :

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DRUG
DISCOVERY/DEVELOPMENT
PROCESS
Post
registration
monitoring
Discovery/
refinement
Safety
and
toxicity in
animals
Volunteer
studies;pa
tient
studies
Regulator
y process
Marketing

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* Regulatory approval –
Ranbaxy received approval from Central Drugs Standard Control
Organisation (CDSCO) to manufacture and market Synriam
(arterolane maleate and piperaquine phosphate tablet 150+750 mg)
in India, for treating uncomplicated malaria in adults caused by
Plasmodium vivax parasite.
Phase III clinical trials for this drug conducted in India successfully
demonstrated its efficacy and tolerability as comparable to
chloroquine.
The company has also received permission to conduct Phase III
clinical trials for the pediatric formulation in pediatric patients of
uncomplicated Plasmodium falciparum malaria.

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* Market launch :
After the issuance of the regulatory approval, on Apr 25, 2012,
a new chapter in the history of Research & Development in
India, Ranbaxy Laboratories Limited (Ranbaxy) launched
Synriam™, for the treatment of uncomplicated Plasmodium
falciparum malaria, in adults
*Post-launch :
Analysis of the new formulation begins with the Phase IV of
clinical testing,developing new forms to administer the drug
and marketing it.

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Project management is a complex undertaking
with many stages and processes .It should follow
the full business cycle from the definition and
justification of the project,through to delivering
benefits to the business.
What companies want from project management
is cost-effective planning,execution and
monitoring of projects,faster project
procedures,optimized business processes and
resources;fewer routine activities.
Comparison of various projects in order to
identify at a glance which ones to go ahead with
is also a major concern.

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REFERENCES
* Richard B. Chase, ‘Operations & Supply Management’,12th
edition,McGraw Hill Education India
* http://www.ranbaxy.com/ranbaxy-launches-synriam-indias-
first-new-drug/
* http://www.ranbaxy.com/ranbaxy-receives-cdsco-approval-
to-market-synriam-in-india-for-treatment-of-malaria-
caused-by-plasmodium-vivax-parasite/

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THANK YOU