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MPS
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Medical Pharmacologists Society

Date: 15th Sept, 17 Issue 01 Volume 2017

Title/Article Page
Cover Page 1
Presidents Message 2
Editorial Board 2
Drug Repurposing 3
Scientific Webinars Links 4
MPS Submitted Comments to WHO 4
Expect Soon 4
Upcoming Events 5
Regulatory Activity 6
MPS Councils and Chairs 6
A MD Students Perspective on MPS 7
FDA Updates 8
MPS Councils Update 9
Favorable Changes at CDSCO 10
How to Join MPS? 14
Amlodipine and Psoriasis 17
Introduction of MPS Board Members 18
Paracetamol Induced Baboon Syndrome 20
Valbenazine 21
List of Registered Members in MPS 22

Views of MPS Members

Dr. S Z Rahman 3
Dr. Prakash BM 3
Dr. Pavan Malhotra 11
Dr. Sanjeev Gupta 11
Pharmacogenomics Workshop 23

About MPS: MPS is a registered society as per Karnataka Society Registration Act, (1960). This
society represents the views of Medical Pharmacologists across India.

Communication Address Registered Address

Dr. Shiva Murthy N Medical Pharmacologists Society
No 41, 2nd cross, 3rd main C/O Magna Health Solutions No. 78/A-246,6th Block
Guru Raghavendra Nagar Rajajinagar, Bangalore-560010
JP Nagar 7th Phase Bangalore 560078 Karnataka, India

Office email id: mps.mdpharmacologists@gmail.com. Website ID: www.mpsmdpharmac.org

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From the Presidents desk

Editorial Board Important Milestones of MPS

Chief Editor
Registered on 01-Oct-2016
Dr. Sandeep Kaushal
Executive Editor Bank account opened in Apr 2017
Dr. Melvin George
Memberships started from May 2017
Associate Editor
Dr. Anant Patil Website domain registered in June 2017
Contributors
A total of 42 members are registered as on
Dr. Shiva Murthy N
Dr. Anant Patil 31 August 2017
Dr. S Z Rahman
Dr. Prakash B M
Dr. Pavan Malhotra
Dr. Sanjeev Gupta
Dr. Shiva Murthy N
Dr. Sonali Kirde
Dr. Sarju Zilate
Dr. Abhishek Phatak
Greetings from Medical Pharmacologists Society (MPS)!!!.
Dr. Vikas Sharma
Pharmacology is cornerstone of the medical sciences. As all medical subjects started evolving with addition of
Graphics and Layout
different subspecialists, significant developments have also happened in our specialty domain. Pharmacology
Dr. Shiva Murthy N
has evolved in all domains including pre-clinical research, clinical research, research and development,
Dr. Shashi Kiran
Dr. Melvin George
pharmacovigilance and medical affair functions. Considering these changes, there is a need for more focused
Dr Malini Shivanna
approach to provide opportunities of learning and knowledge sharing to MD Pharmacologists so as to
Staff of Magna Health Solutions
empower them to work more effectively. MPS was conceived with the interest to strengthen the profession in
Disclaimer all possible directions possible by utilizing available opportunities and technologies.
This newsletter is for internal Its my privilege to present the maiden issue of MPS Connect our official newsletter which covers academic
circulation and is free of cost. articles, latest updates in the field of pharmacology and developments in MPS over last few months.
This newsletter may be Within short period, we have achieved significant progress. On the behalf of MPS, I thank all those who
circulated among MD
pharmacologists, medical
supported the formation of society and are working hard to lay strong foundation for the society. I wish to
scientists and members of MPS report contributions of following people who supported the society by taking self initiatives:
worldwide. Dr Sujay Patil (Cipla, Mumbai) - Logo Design
Not for commercial sale. Dr. Veena RM (BGS Medical College, Bangalore) - Registration of Society
This newsletter may be utilized
Dr.Sonali Kirde (PG Student, MGIMS, Sewagram), Student Representative who volunteered to support
for academic purposes and no
copyrights are reserved for the growth of MPS by adding more than 550 new members to the group on social media
material referred from various Dr. Meeta Burande (Prof and HOD of DY Patil Medical College, Kolhapur) - Volunteered to host the first
sources. conference at Kolhapur
Rights are reserved for the
Dr. Bikas Medhi (Prof. PGIMER, Chandigarh) - Agreed to support PV training program for PG students
matter created by MPS and its
contributors. this should not be and work as Organizing Secretary for this program
reproduced without permission Dr Jerin Jose (Clin Pharmacologist, Rajgiri Hospital, Cochin), Dr Vikas S Sharma, (PG Student GMC,
of MPS office. Nagpur) and Dr Anant Patil, (Asst Professor, Bharti Vidyapeeth Dental College, Navi Mumbai)- Speakers
All communications related to for webinars organized by MPS
this newsletter may be
Dr Ravindra Honrao, (Drug Safety Physician, Bioclinica, Mysore) - Development of the website.
directed to
mps.mdpharmacologists@gmail.com If I am unable to mention names of other contributors, it is purely unintentional. I will always have
Note opportunities to acknowledge their contribution in the upcoming issues. I thank all the office bearers and
Readers may execute their hundreds of MD pharmacologists who stood always with me and working as backbone of the society.
scientific acumen before
utilizing the data. No damages
Last, but not the least, I would like to thank the editorial board for successful introduction of the first issue of
can be claimed due to any
reasons that may arise after MPS Connect in a reader friendly, impactful and appealing format.
utilization of the information
with or without modifications. Please feel free to write to me at shivuindia@gmail.com for extending support to MPS!!!.
Editors Yours truly,
Dr Shiva Murthy N, President, MPS.
 MPS

Drug repurposing: A feasible alternative/Adjuvant

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to traditional drug discovery and development

The major challenges including cost and timelines that

pharmaceutical industry faces while bringing new drugs to
the market are very well known. In addition, stringent
regulations and increasing demands from patients make the
tasks of drug development further difficult. The process is
always surrounded by the risk of failure not only during
drug development phase but also after introduction of the
product in the market.1,2
The outcome of this complex scenario is reducing
productivity in drug discovery and development resulting
Dr. Syed Ziaur Rahman, MD, PhD
in gap between patients need and available treatment Professor
options. Identifying new indications for existing drugs is a Dept of Pharmacology & Depty Med
solution to tide over these difficulties. Newer indications Superintendent JNMC, Aligarh
Dr. Anant Patil
MD (Pharmacology),Navi Mumbai, can be found either by serendipity or by focused approach.
anantdpatil@gmail.com The focused efforts towards studying mechanism of action I would like to extend my
can provide insights into newer indications for the existing congratulations on the
drug. inaugural publication of MPS
Connect. This way , our
Drug repurposing (also referred as drug repositioning) is a systematic approach to overcome existing
registered members would
limitations associated with drug development and research. Drug repurposing refers to the mechanisms or also be able to show case
processes for the identification of new indications for the existing drugs, drugs which not in use or candidate their achievements. The
drugs under development phase.1 Robust pipeline with lesser risk of failure, development of safe and whole team deserve kudos
efficacious drug with reduced cost could be possible with drug repurposing. This is a viable for this great initiative.
alternative/adjuvant option for traditional drug discovery and development and if used optimally it can provide
safer medicines for the patients.1 No wonder, that understanding its benefits, drug repurposing has attracted
significant attention of researchers in recent years. Under this process, existing medicines are studied for their
therapeutic use which is significantly different than original product. Several multinational pharmaceutical
companies have dedicated resources for this purpose. Similarly, there are companies which offer consulting
services and platform for research for drug repurposing, repositioning and rescue.

There are several examples of existing drugs for which new indications have been studied. A classical example
is thalidomide. The medicine initially used for the treatment of morning sickness in pregnant women resulted
in historical disaster. However, later it was studied for the treatment of erythema nododum laprosum (ENL).
Today, patients with ENL are effectively managed with thalidomide, thanks to drug repurposing.3

Just to give some more examples, amitriptyline originally approved as antidepressant drug, later was found to Dr. Prakash Bruhan Math, MD
Dept of Clinical Pharmacology,
be useful for the treatment of neuropathic pain. Similarly, gabapetin originally approved for seizures was later
Faculty of Medicine, Jazan University,
studied for the indication of postherpetic neuralgia.1 Saudi Arabia
Understanding molecular data, analytical expertise, resources for validation of the concept and clinical
development program for confirming the efficacy and safety of existing molecule in new indication are some of
the important requirements for development of robust pipeline of drug repurposing.4
Happy to know MPS is
conducting quality
Drug repurposing is a rapidly flourishing field having significant potential to provide safer treatment options
for several pathological conditions with lesser cost and shorter timeline, if explored systematically.
events . It is the
responsibility of the
pharmacologist to
References: contribute and
1. Naylor S, Schonfeld JM. Therapeutic drug repurposing, repositioning and rescue. Part I Overview. Drug Discovery World Winter
2014/15:49-62 strengthen the Society.
2. Hodos RA, Kidd BA, Shammer K, Readhead BP, Dudley JT. In silico methods for drug repurposing and pharmacology. WIREs Syst Biol Med
2016. doi: 10.1002/wsbm.1337
3 Ashburn TT, Thor KB. Drug repositioning: Identifying and developing new uses for existing drugs. Nature Reviews. Drug Discover.
2004;3:673-683 Editors
4. Cha Y, Erez T, Reynolds IJ, Kumar D, Ross J, Koytiger G, et al. Drug repurposing from the perspective of pharmaceutical companies. British
Journal of Pharmacology 18 May 2017. doi:10.1111/bph.13798
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EXPECT SOON
SCIENTIFIC WEBINARS 1.Pharmacovigilance
MPS conducts webinars on various topics regularly (generally once in a month). training program (15 days
Following are the recently completed programs (Ctrl+Click on the title to see recorded to one month) at
webinar in MPS YouTube channel): PGIMER, Chandigarh for
1.Strategies to Develop Inhibitors of Motif-Mediated Protein-Protein Interactions as Drug Leads PGs studying across India.
https://www.youtube.com/watch?v=NQ_ShiaNSFw&t=538s (application submitted)
2. Medication Safety: Role of Clinical Pharmacologist
Part 1: https://www.youtube.com/watch?v=nu_LTSA6bLU&t=2s
2. Workshop on
Part 2: https://www.youtube.com/watch?v=0sycRNAgiAQ&t=13s
3. Manuscript writing: Basics that one should know Pharmacogenomics
Part 1:https://www.youtube.com/watch?v=T0uKD0Kkx6M (in planning stage)
Part 2: https://www.youtube.com/watch?v=K-ztGC2ZgfQ
Part 3: https://www.youtube.com/watch?v=K-ztGC2ZgfQ

MPS reviewed and submitted its comments on the "WHOs third Global
Patient Safety Challenge - Medication Without Harm" documents:
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Thanks to the interested participants for great response for both meeting

Organized by Department of Clinical Pharmacology & Department of Pharmacology

SRM Medical Collage Hospital & Research Centre In assoctation with Medical
Pharmacologists Society. Medical Council of India & Indian Council of Medical Research

Last date for early bird

registration
July 15, 2017
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MPS COUNCILS AND CHAIRS

Join MPS councils if you wish to contribute to the various initiatives of the society. Councils and chairs are below:

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CME COUNCIL Publication COUNCIL

Chair: Dr. Sandeep Kaushal Chair: Dr. Melvin George

(mps.cmecouncil@gmail.com) (mps.publication@gmail.com)
Vice Chair: Dr. Pooja Roy Vice Chair: Dr. Anant Patil
(mps.cmecouncil@gmail.com) (mps.publication@gmail.com)

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HOSPITAL clinical practitioner

MEDIA & PR COUNCIL
COUNCIL
Chair: Dr. Subhrojith Bhowmick Chair: Dr. Shiva Murthy N
(mps.hcp@gmail.com) (mps.mdpharmacologists@gmail.com)
Vice Chair: Dr. Jerin Jose Cherian
(mps.hcp@gmail.com)

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RESEARCH COUNCIL Team PV Mission

Chair: Dr. Phulen Sarma Team Lead: Dr. Sapna Patil

(mps.rescouncil@gmail.com) (mps.pvig@gmail.com)
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A MD Student s perspective ON MPS

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Dear Readers, of nation and most importantly learning the subject from experienced
First of all, I would like to seniors. MPS is free of differences in terms of seniority, region, religion,
thank Dr Shiva Murthy N, linguistic barriers etc. Every member is considered precious and is
President & Co-founder given equal chance to contribute.
of MPS for giving me an We have excellent researchers, prominent academicians, entrepreneurs
opportunity to play an in the field of Pharmacology. Despite of all the talent, our speciality has
active role in MPS and not received the importance and respect that we deserve, especially
having faith in me. in India.
Being a passionate lover So Friends, the time has come when we should introspect and work
Dr. Sonali S. Kirde
of the subject, my dream dynamically towards improving our current status. I request all the
MD Pharmacology student (final year), i s - To b u i l d m y resident doctors of MD Pharmacology to join MPS (become members)
Student Representative MPS,
MGIMS, Sewagram, Maharashtra. profession as the most
in early stage of career and work in bringing proposals to the
dr.sonalikirde@gmail.com respected one.
government i.e., amendments in current research guidelines, changes
To fulfil this dream, I in the syllabus, Pharmacovigilance status in India, participation in
always wished to have an organisation which will work
informative workshops/conferences, publications in upcoming MPS
selflessly for the betterment and upliftment of status of
medical pharmacologists in India, and MPS was the most journals, CMEs, industrial internship/orientation programmes,
reliable one I found, with its clear objectives and dedication to support in job search, grant request for research studies, free webinars
unite and work. and many more. MPS complements your outlooks and if feasible, they
MPS is a society exclusively for MD Pharmacologists. I am accept it as well.
connected with this team even before its registration (within
So, let us Explore, Learn and Develop, a real Pharmacologist in us.
one week of my first year PG admission through FB, when its
name was AIMPS in 2015). Recently, I have committed to MPS
by applying for life membership and to begin with, I have
added more than 500 MD Pharmacologists in MPS Whatsapp
groups. Being a registered MPS member, it has given me a
ARE YOU READY TO JOIN
platform to participate in all important decisions, helping me THE HANDS? ARE YOU READY TO
in building my confidence, establishing contacts and STAND FOR YOUR OWN DIGNITY?
communicating with eminent pharmacologists from all parts

FDA FDA approves VoSEVI for Hepatitis C

UPDATES
th
On 18 July, 2017,the U.S. Food and Drug Administration approved Vosevi to treat adults with chronic
hepatitis C virus (HCV) genotypes 1-6 without cirrhosis or with mild cirrhosis.
Vosevi is the first
treatment approved Vosevi is a fixed-dose, combination tablet containing two previously approved drugs sofosbuvir and
for patients who velpatasvir and a new drug, voxilaprevir. It is manufactured by Gilead Sciences, Inc.
have been Vosevi is the first treatment approved for patients who have been previously treated with the direct-
previously treated acting antiviral drug sofosbuvir or other drugs for HCV that inhibit a protein
called NS5A
with the direct-
Recommendations for dosing of Vosevi are different depending on viral
acting antiviral
genotype & prior treatment history.
drug sofosbuvir or
The most common adverse reactions in patients taking Vosevi were headache,
other drugs for
fatigue, diarrhea and nausea.
HCV that inhibit a
Vosevi is contraindicated in patients taking rifampin.
protein called
NS5A. Reference: www.fda.gov
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FDA clears expanded use of cooling cap to

FDA reduce hair loss during chemotherapy..
UPDATES rd
On 3 July 2017, the USFDA cleared the expanded use of a cooling cap to reduce hair loss ,a common side effect
during chemotherapy of solid tumor cancers.
The Dignicap cooling The Dignicap cooling system is a computer-controlled system which features a head-worn cooling silicone cap.
system is a computer- A cap is worn on the head and circulates liquid to a cap to cool the scalp during chemotherapy treatment.
The cap is covered by a second cap made from neoprene, a type of rubber that holds the cooling cap in place and
controlled system which
acts as an insulation cover to prevent loss of cooling.
features a head-worn This is to be worn 30 minutes before chemotherapy and for another 90 minutes after chemotherapy.
cooling silicone cap. According to FDA release, "more than 66 percent of patients treated with the Dignicap reported losing less than half their hair.
Mechanism - Cooling constricts blood vessels in the scalp, which reduces the amount of chemotherapy that reaches cells in the hair
A cap is worn on the head
follicles. It also decreases the activity of the hair follicles and slows down cell division, making them less affected by chemotherapy. The
and circulates liquid to a combined actions are thought to reduce the effect of chemotherapy on the cells, which may reduce hair loss.
cap to cool the scalp The most common side effects of the cooling system include cold-induced headaches and neck and shoulder discomfort, chills and
pain associated with wearing the cooling cap for an extended period of time. The risk of the chemotherapy drug missing an isolated
during chemotherapy grouping of the cancer cells in the scalp because of the cooling cap is rare.
treatment. Dignicap may not function with some chemotherapy regimens though.
Reference: www.fda.gov

FDA approves L-glutamine oral powder for sickle cell disease

On July 7, 2017 ,USFDA approved Endari (L-glutamine oral powder) packaged as 5 grams powder in a paper-foil-plastic laminate packet for oral
administration.
Sickle cell disease is an inherited blood disorder in which the red blood cells are abnormally shaped (in a crescent, or "sickle," shape). This
restricts the flow in blood vessels and limits oxygen delivery to the bodys tissues, leading to severe pain and organ damage.
Endari is indicated to reduce the acute complications ofSickle cell disease in adult and pediatric patients five years of age and older.
Common side effects of Endari include constipation, nausea, headache, abdominal pain, cough, pain in the extremities, back pain and chest pain.
Endari received Orphan Drug designation for this use, which provides incentives to assist and encourage the development of drugs for rare
diseases.
FDA granted the approval of Endari to Emmaus Medical Inc.
Reference- www.fda.gov

FDA Approves Belimumab- monoclonal antibody as a

BENLYSTA is a B-
lymphocyte stimulator
(BLyS)-specific inhibitor
indicated for the treatment
of adult patients with
active, autoantibody-
positive, systemic lupus
erythematosus who are
receiving standard therapy.
Reference: www.fda.gov
Weekly Self-Administered Injection to treat Lupus
On July 7, 2017,the U.S. Food and Drug Administration approved BENLYSTA (Belimumab- monoclonal antibody) indicated for the
treatment of adult patients with active, autoantibody-positive, Systemic Lupus Erythematosus (SLE) who are receiving standard
therapy.
BENLYSTA is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of adult patients with active,
autoantibody-positive, systemic lupus erythematosus who are receiving standard therapy.
Lupus is a disease of the immune with high levels of a certain protein in their blood. BENLYSTA binds to and limits the activity of the
protein.
When given together with other medicines for lupus, BENLYSTA decreases lupus disease activity more than other lupus medicines
alone.
GSKs Benlysta SC will be self-administered as a weekly injection into the fatty layer of tissue just under the skin.
It will be available as either a single-dose pre-filled syringe or from a single-dose auto-injector.
The most common side effects of BENLYSTA are nausea, diarrhea, fever, swelling at the site of injection etc.
It is not known whether BENLYSTA is safe in children or not.

Compiled by: Dr Sonali S. Kirde

Student Representative,MPS
 MPS

MPS Councils Update

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CME Council update:

1. Completed four webinars recordings of which are available in MPS YouTube channel.
2. Working actively for organizing upcoming webinars.
3. Working for announcement of the Annual Conference at Kolhapur to be held in July 2018.
4. NWCRM workshop Chennai to be held between 14-16, Sept 2017 (Registrations closed)
5. GCP workshop, Gulbarga to be held on 18th September 2017 (Registrations are going on)

Research Council update:

1. Working on Nodal center proposal document.
2. Working on PV Training program at PGIMER, Chandigarh for PG students.
3. Working on Pharmacogenomics workshop; proposals will be submitted soon. Tentative dates are November
13-15th, 2017.

Journal Council update:

1. Instructions for the authors and SOP for processing of articles submitted to Journal of Medical Pharmacologists
Society (JMPS) is prepared and under review.
2. MPS ConnectNewsletter will be released on regular basis. MPS Connect can support publication of council
updates and status of their programs. MPS Connect will also give opportunities to registered members to publish
their achievements, awards received if any in different scientific forums, publications and related brief updates
Members may also share learnings from conferences and workshops they attended.
3. Journal council has short listed from the members for Editorial board, National and International advisory board
members, which shall be published soon.

Hospital Clinical Pharmacology Council update:

1. Council Chairs and Co-chairs identified
2. Council provided comments on WHOs documents related to "WHOs third Global Patient Safety Challenge
- Medication Without Harm"
3. Dr Jerin Jose conducted one webinar on Medication Safety: Role of Clinical Pharmacologists on 02-Jul-2017.

Media and Public Relationship Council update:

1. MPS You Tube Channel opened and published eight video presentations. (ctrl+click) to
(https://www.youtube.com/channel/UCCeRvMBrHHUkDmPVdmEPIoA/videos?view_as=subscriber)
2. WhatsApp groups: more than 750 MD pharmacologists connected. (send message to 8884328275 to
join the group)
3. Facebook MPS group has more than 900 MD pharmacologists. Join the group at (ctrl+click)
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Favorable Changes at CDSCO ofce are Expected

to Fasten the Access to New Drugs in India

Contents:
1. Introduction
2. SUGAM Online Licensing System
3. Global clinical trial (GCT) Approval Process
4. NDA Approval process
5. Other updates
Dr. Shiva Murthy N MBBS MD MBA, 6. Conclusion
President, Medical Pharmacologists Society,
India. shivuindia@gmail.com

Introduction
Central Drugs Standard Control Organization (CDSCO) is responsible for controlling quality and standards of drugs marketed in India. Drugs
Controller General of India (DCGI) is the signing authority for all the decisions taken on behalf of CDSCO. DCGI office works in compliance with
Drugs and Cosmetics Act 1940 and Rules 1945. This office is responsible for review and approval of New drugs (NDA), devices (NMAs),
subsequent news drugs (SNDAs) and their variations. In addition, DCGI office is also responsible for review and approval of clinical trials (CTAs)
that are conducted in India. With this background, I would like to discuss recent changes adopted for review and approval of NDAs and CTAs in
India at CDSCO.Thus article covers updates on
1. SUGAM online licensing system
2. GCT approval process

SUGAM Online Licensing System

DCGI office is going digital with the introduction of SUGAM Online Licensing System. This online system is made of different modules. These
modules are made operational as and when ready for public release.Various services already available through SUGAM are listed in table 1.

Table 1: Services offered by DCGI through SUGAM Online Licensing System

Sl N. Date of Implementation Type of Services (Module)
1 14- Nov-2015 import of application and registration of drugs

2 01-Apr-2016 registration of medical devices and diagnostics

3 30-May-2016 medical devices online application system

4 06-Jun-2016 registration of cosmetics

5 15-Jun-2016 registration of ethics committees

6 15-Jun-2016 t license application (form 12) (import of drugs for the purpose of examination, test or analysis)

7 26-Jul-2016 grant of noc for ba/be studies for export purpose

8 24-Oct-2016 global clinical trials applications

online application for human vaccines ct, marketing authorization, registration
9 04-Feb-2017 of manufacturing site, import licenses
10 15-May-2017 issue of form 13 (issue of reports for test/analysis performed at cdtl/rdtl)
Granting NOC and registration of drugs meant for export
Additional modules expected soon
Grant and renewal of blood bank and CLAA workflow
COPP certificate
Online Process for New Drugs, FDCs, Subsequent New Drugs
CT post approval And SAE reporting
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Favorable Changes at CDSCO ofce are Expected

to Fasten the Access to New Drugs in India

GCT Approval Process:

DCGI office follows three step processes for review and approval of GCTs. Once the application is submitted, it
is placed before Subject expert committee (SEC). If SEC approves the application, it goes to Technical
Committee (TC). If this step is successfully crossed, then it goes to Apex Committee (AC) for review and
approval. Type of studies processed by respective committee are given in the figure below. (Fig 1)

Figure 1: GCT approval process Dr. Sanjeev Gupta

Senior Resident
Deptt.of Pharmacology
and Therapeutics
ASCOMS & H. SidhraJammu
SEC

TC

6-8 members Ministry of Health, AC Ministry of Health,

Academicians and Regulators and Invited Regulators and I take pleasure in recognising
regulators consultants Invited consultants the efforts of Medical
Monthly meetings Pharmacologists Society
First come first Monthly meetings Once in 3 months (MPS) which has brought
served together professionals from
Phase 1,2,3 (b) (till Phase 1,2,3 (a)
45 days to 3 months academia and industry ,
TC only) (require all three across the country and
for first meeting
level approval) abroad. Since it was
Phase 1,2,3 (a&b)
Phase 4 study, NIS conceived in 2015 and now
(till SEC only) blossomed, I think we shall
Label Update claims attain greater heights and
(till SEC only) meet the objectives of the
society very soon as it is a
fully democratic set up .With
warm regards

34th Apex committee meeting was held on 02-Jun-2017 and the committee suggested amendment in the
existing process with following recommendations (Extract of the minutes is as below):
(i) GCT should be placed before the SEC and where these are accepted/rejected by the SEC, no further
approval of the Technical Committee or Apex Committee will be required
(ii) In cases, where DCGI is not in agreement with the recommendations of SECs with respect to GCT, the
matter may be placed before the Technical Committee for a final decision within a month of the
recommendations of the SEC
(iii) If the cases rejected by the SEC shall, in case the applicant feels aggrieved, be placed before the
Technical Committee for its consideration. Where theTechnical Committee decides, for reasons to be
recoded in writing to overrule the SEC, the decision of the Technical Committee shall be final
(iv) Investigational New Drug (IND) Clinical trial applications shall be placed before the IND Committee
and the decision taken by the IND Committee shall be final. DGHS or Spl DGHS may be invited to the
meetings of IND Committee. In rare cases,where the IND Committee, considers it necessary to keep the Dr.Pavan Malhotra,
ApexCommittee informed, the matter may be placed before the Apex Committee for guidance. Director Principal.
ASCOMS and Hospital,
Sidhra ,Jammu.

I am pleased to be the part of Medical pharmacologists Society which is a fast growing

organization and professional body of subject experts through out the country. An
effort to amalgamate the experienced professionals with the professionals of next
generation is an wonderful venture where the youngesters will learn from the
experiences of veterans and veterans will learn from the ideas of the younger ones.
I wish the organization a grand success in all their forth coming ventures.
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Favorable Changes at CDSCO ofce are Expected

to Fasten the Access to New Drugs in India

NDA Approval process:

New Drug Applications (NDA) process is similar to GCTs and three level approval
processes is followed. The above cited 34th Apex committee dated 02-Jun-2017 minutes is
applicable only for GCTs. Therefore, NDA approval process will continue to be three level
processes in the sequence as follows. (figure 2).

GCT Approval Process

SEC

TC

AC
6-8 members Ministry of Health, Ministry of Health,
Academicians and Regulators and Invited Regulators and Invited
regulators consultants consultants
Monthly meetings Monthly meetings Once in 3 months

First come first served NDA, NDDS, New NDA, NDDS, New

45 days to 3 months for Strengths Strengths (Require all

first meeting three level approval)
NDA, NDDS, New
Strengths
Label Update claims
(till SEC only)

5. Other updates:
DCGI office releases notices time to time based on the needs . Industry and associations represent on regular basis to DCGI
office and submit requests to modify the existing rules with rationale to improve the compliance to law/rules. Following are
the four notices that have had a major impact on the way we conduct clinical trials in India:
1. Investigators were allowed to conduct more than 3 trials at any given point of time (DCGI office notice dated
02-Aug-2016)
2.Trials were allowed in any hospital with less than 50 beds (DCGI office notice dated 02-Aug-2016)
3. Additional sites may be added to the already approved trial without waiting for DCGI ap-proval. (DCGI office notice dated
03-Aug-2016)
4. Importing/Exporting of biological samples of clinical trials does not need license from DCFT. (DGFT notification dated
04-Aug-2016)
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Favorable Changes at CDSCO ofce are Expected

to Fasten the Access to New Drugs in India

Conclusion:
DCGI office is going through changes and started adopting to the digital innovation.This is a welcome sign. Online systems like SUGAM are expected to
increase the transparency in processing NDAs and CTAs and also reduce the timelines to four to five months from existing seven to nine months.
Relaxations granted by the DCGI authorities are expected to smoothen the clinical trials operations. These changes are expected to boost the Indias
potential to become major destination for conducting clinical trials in the near future. This will also augment the new drugs approval process and faster
access to newer and better medicines in par with FDA and EU.

References:
1. http://www.cdsco.nic.in/forms/list.aspx?lid=2028&Id=31 site as accessed on 31-Jul-2017.
2. SUGAM operational manual: https://cdscoonline.gov.in/CDSCO/resources/app_srv/cdsco/global/COMPLETE%20GUIDELINES.pdf
3. 34th Apex committee meeting minutes:
http://www.cdsco.nic.in/writereaddata/Minutes%20of%2034th%20Apex%20Committee%202%20june%202017%20.pdf

MPS MEMBERSHIPS
MPS offers Five types of Memberships:
1. Life member (Student)
2. Life member (Professional)
3. Student member
4. Honorary member (Individual) and
5. Honorary member (Institution)
If you want to know more in detail about the objectives, opportunities, benefits, procedures regarding these
memberships, please feel free to contact at mps.mdpharmacologists@gmail.com

RECEIPTS AND MEMBERSHIP

CERTIFICATES
All the registered members will receive the receipts with bank transaction ids and date of transaction.This will be done once
in a month on receipt of bank statement. Members should submit the online scanned copies of their MBBS, MD degree and
MCI registration certificates to MPS office ID with filled and signed copy of application form.
Membership certificates format is under preparation and shall be issued once the printed certificates are available in the
MPS office.
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Application form and instructions for joining the society is below:

HOW TO JOIN MPS? *
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Application form and instructions for joining the society is below:

15
HOW TO JOIN MPS? *
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Application form and instructions for joining the society is below:

 Amlodipine and Psoriasis *
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*

Amlodipine, a L type calcium channel blocker of dihydropyridine (DHP) group

introduced commercially in 19901 is included in the World Health Organization's List
2
of Essential Medicines Amlodipine is indicated for hypertension, chronic stable
angina, Prinzmetal angina and angiographically recognized coronary artery disease
(CAD).3 It is the most popular and widely used antihypertensive in elderly.

Amlodipine is pharmacokinetically distinct DHP. Its oral absorption is slow but

Dr. Sarju Zilate
(M.D. Pharmacology, MGIMS, Sevagram),
Assistant Professor, Raipur Institute of Medical
Sciences(RIMS), Raipur.
drsarjuzilate007@gmail.com
complete. Peak blood level are achieved after six to nine hours, so unlike other DHPs
early vasodilatory side effects like palpitation, flushing and headache are rare.As it is
4
longer acting, can be used once a day providing potential for good patient compliance
resulting in popularity among the health care providers.

Common adverse events reported with use of amlodipine include edema and pulmonary edema. Less common
adverse events are headache, fatigue, palpitations, dizziness, nausea, flushing, abdominal pain, somnolence, male
5
sexual disorder, drowsiness, pruritus, skin rash, muscle cramps and muscle weakness. Recently in May 2017 drug
safety alert, National Coordination Centre - Pharmacovigilance Programme of India (PvPI) has implicated
psoriasis as adverse reaction of amlodipine. this is supported by case control study conducted by Cohen and
6
colleagues stating association of psoriasis with calcium channel blocker. This is a matter of concern as amlodipine
is being routinely prescribed antihypertensive.

Psoriasis is chronic inflammatory skin disorder characterized by erythematous plaques covered by silvery
scale.Apart from genetic causes, it can also be caused by many drugs. Drugs anticipating psoriasis are lithium,
chloroquine and hydroxychloroquine, propranolol, quinidine and indomethacin.7

Health care providers should be vigilant while prescribing amlodipine, keeping in mind the seriousness of
psoriasis. If came across this adverse reaction,health care providers or patients,are advised to report it to NCC-
PvPI either by filling of Suspected Adverse Drug Reaction Reporting form (http://www.ipc.gov.in) or by
Suspected Adverse Drug Reaction Reporting app or by PvPI Helpline No. 1800-180-3024.

References:
1. Chorghade MS (Mukund S. Drug discovery and development. Volume 1, Drug discovery [Internet]. Wiley-Interscience; 2006 [cited 2017 Aug 2]. Available
from: https://books.google.ca/books?id=Bu5IHnBxjxwC&pg=PA207&hl=en#v=onepage&q&f=false
2. World Health Organization. 19th WHO Model List of Essential Medicines [Internet].
Http://Www.Who.Int/Medicines/Publications/Essentialmedicines/En. 2015. Available from:
http://www.who.int/medicines/organization/par/edl/expcom13/eml13_en.pdf
3. Norvasc (amlodipine) dosing, indications, interactions, adverse effects, and more [Internet]. [cited 2017 Aug 2]. Available from:
http://reference.medscape.com/drug/norvasc-amlodipine-342372#0
4. Tripathi K. Essential of Medical Pharmacology. Seventh Ed. Tripathi M, editor. New Delhi: Jaypee Bros; 2013. 549 p.
5. Norvasc (amlodipine) dosing, indications, interactions, adverse effects, and more [Internet]. [cited 2017 Aug 2]. Available from:
http://reference.medscape.com/drug/norvasc-amlodipine-342372#4
6. Cohen AD, Kagen M, Friger M, Halevy S. Calcium channel blockers intake and psoriasis: a case-control study. Acta Derm Venereol [Internet]. [cited 2017
Aug 2];81(5):3479. Available from: http://www.ncbi.nlm.nih.gov/pubmed/11800142
7. Psoriasis causes and known triggers | National Psoriasis Foundation [Internet]. [cited 2017 Aug 2]. Available from: https://www.psoriasis.org/about-
Editors
psoriasis/causes
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INTRODUCTION TO MPS BOARD MEMBERS

Dr. Shiva Murthy N - President , MPS

Dr. Murthy holds MD Pharmacology from RGUHS, Karnataka, MBA from SMU and MBBS from GU, Gulbarga. He has
16 years of experience in CRO and Pharma industry. He played key roles in establishment/management of clinical
research/regulatory departments in Novo Nordisk, Semler, Notrox, Jubilant, Quartesian, ICON, Fortis, and Lotus labs.
He was fortunate to work in various clinical research specialties like BA/BE, Phase I - IV studies, PV, Regulatory and
Quality operations. The projects managed by him were in compliance to various regulatory agencies including FDA,
EMEA, ANVISA, TGA and DCGI etc.,

Dr Sandeep Kaushal - Vice President, MPS

Currently working at Dayanand Medical College and Hospital, Ludhiana as Assistant Dean Academics, Professor & Head
of Pharmacology. Did MD Pharmacology from Panjab University, Chandigarh ( 1997) and awarded Best Post Graduate
Award in Medical sciences. Trained in clinical pharmacology, epileptology, pharmacogenomics, medical education .
Awarded Dr. B.C. Roy National Award and fellowship of prestigious international and National Societies. Contributed to
national guidelines, journals in various capacities. Published 80 papers and seven chapters and one book.

Dr. Pooja Roy - General Secretary, MPS

Dr. Pooja Roy has completed her MBBS from Dr B.R.Ambedkar Medical College and then completed her MD
Pharmacology from VIMS & RC, Bangalore. she has worked as a faculty in VIMS & RC from 2014 July to 2015
December following which she joined Dr Reddy's laboratories and has since been working there in Medical Affairs. She
is a reviewer for three journals; has worked as a freelance medical writer and also has served as a research assistant in
Pharmacovigilance unit, VIMS & RC, Bangalore.

Dr. Melvin George - Treasurer, MPS

Dr. Melvin works as an Asst Prof in the Dept of Clinical Pharmacology at SRM Medical College Hospital, Chennai. He
completed his MBBS, MD Pharmacology & DM Clinical Pharmacology from JIPMER, Pondicherry. He has been an
investigator in phase 3 & phase 4 clinical trials in areas such as acute coronary syndrome, heart failure, chronic stable
angina and stroke. His current areas of research include cardiovascular biomarkers. He is a regular speaker at workshops
on GCP, and research methods. He was recently awarded an ICMR research grant for a project on cardiac biomarkers.

Dr Malini Shivanna - Board Member, MPS

Postgraduate from Manipal university, gaining a short stint of teaching experience, moved on to develop new skills in
planning and execution of medico-marketing strategies for drugs cutting across various pharmaceutical companies, in a
global organisation. Further evolved as an entrepreneur to build a business on a strong foundation of ethics and quality to
the best possible extent- MAGNA Health Solutions,11 year old organisation. With all challenges continue to enjoy the
clinical practice in a charitable clinic!
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INTRODUCTION TO MPS BOARD MEMBERS

Dr. K Lakshmi Narayana - Board Member, MPS

Currently working as Head of Department of Pharmacology, Vijayanagar Institute of Medical Sciences, Bellary,
Karnataka. Dr. K L Narayana completed his MBBS and MD Pharmacology from Govt Medical College, Bellary. Guided
more than 15 PG students as PG teacher and has more than 20 years teaching experience in MCI recognized institutes.

Dr. Phulen Sarma - Board Member, MPS

Dr. Phulen Sarma completed his MBBS from Assam Medical College, Dibrugarh in 2009. After that he worked as a
medical officer under Assam Govt. In 2011, he joined as a resident in the Department of Neurology, Assam Medical
College. He completed his MD Pharmacology in 2014 and joined as Ph.D. in AIIMS New Delhi. In the year 2015, he got
selected in DM Clinical Pharmacology course in PGIMER Chandigarh and currently pursuing the same. His area of
interest are inflammatory bowel disease, autism and pharmacogenomics.

Dr. Akash Gadgade - Board Member, MPS

Dr.Akash finished his MBBS from BLDEAs Sri B.M. Patil Medical College, Bijapur in August 2007 and MD from
Kasturba Medical College, Mangalore in April 2014. Has experience of working as sub-investigator in clinical trials as
well as in BA/BE studies. He has received post-graduate Thesis Grant, from ICMR. He has worked as Regional Medical
Advisor at Dr.Reddys Lab Ltd at Mumbai from June 2014 to June 2016. Presently working as Medical Officer for
National Health Mission, under National Program for Prevention and Control of Cancer, Diabetes, CVD and Stroke(
NPCDCS) involved in screening, management of non-communicable disease.

Dr. Divyalasya TVS - Board Member, MPS

Dr. Divyalasya TVS completed her MBBS from Dr. BR Ambedkar Medical College, Bangalore and MD Pharmacology
from KIMS, Bangalore. Worked as Assistant Professor in the Department of Pharmacology in Narayana Medical College,
Nellore from July, 2015 to April, 2017. Currently, working as Global Medical Advisor in Novo Nordisk, Bangalore
(since May, 2017).

Dr. Jhilli Basu - Board Member, MPS

Dr. Jhilli Basu, MBBS from Calcutta university in 2003, medical officer job till 2009 in various departments (General.
Med, medical centre kolkata, Neurosurgery dhakuria AMRI hospital Kolkata ), master in hospital management from
WBUHS, 2009-2011, hospital administration job 2011-2013 charnock and sanjiban hospital kolkata, MD pharmacology
2013-2016 from mom medical college kishanganj Bihar. She is currently working as an Asst Professor, Department of
Pharmacology IQ city Medical college, Durgapur, West Bengal

Dr. Sushma Y Prasad - Board Member, MPS

Dr. Sushma, completed MBBS from JSSMC, Mysore, Karnataka and MD Pharmacology from Bidar Institute of Medical
Sciences, Karnataka. She worked at Malnad Cancer Hospital, Shimoga as RMO, in SIMSAR, Shimoga and Sambram
institute of medical Sciences, Kolar as Asst Professor in Department of Pharmacology.
 *
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Paracetamol Induced Baboon syndrome

Paracetamol also known as acetaminophen, discovered in 1877, is the most

1
commonly used drug to control fever in all age groups worldwide. It is found to be
safe in pregnant as well as lactating mother. It also relieves mild to moderate pain
including dysmenorrhoeal pain, headache, osteoarthritis, soft tissue lesions, acute
migraine attack.2 It is cheap and easily available medication throughout the world.
Most of the over the counter medications used for the treatment of common cold,
cough, allergy, flu contains acetaminophen as an active ingredient. It is one of the
th
vital drugs in healthcare set up and also included in the 19 World Health
3
Organisations Model List of Essential Medicines. It is rapidly absorbed when taken
orally, well tolerated without causing gastrointestinal irritation or adversely affecting
blood circulation or renal function. It is available in various formulations such as
tablets, capsules, liquid suspension, suppository, intravenous, intramuscular and
Dr. Abhishek Phatak,
(M.D.Pharmacology), effervescent forms.
Insurance Medical Officer, ESIS dispensary,
Bhosari,Pune. In acute paracetamol overdosage, dose-dependent, potentially fatal liver injury is the
abhishekphatak9288@gmail.com
most serious side effect. There have been many reports of hypersensitivity and
anaphylaxis associated with the use of paracetamol.

Apart from these adverse drug reactions (ADRs), paracetamol also can cause rare but fatal skin reactions such as StevensJohnson
syndrome and toxic epidermal necrolysis.

The preliminary analysis of ADRs from the PvPI database reveals that paracetamol is associated with the risk of 'Baboon
syndrome' (BS). It is a systemic form of contact dermatitis with characteristic appearance of well-demarcated patches of
4
erythema distributed symmetrically on the buttocks. The appearance resembles the distinctive red buttocks seen in some male
baboon species. It can also involve armpits and/or upper inner thigh. It is usually not associated with any systemic symptoms. This
term was introduced around three decades ago but now more popularly known as Symmetrical drug-related inter-triginous and
flexural exanthema (SDRIFE).

Apart from paracetamol, systemic therapy with penicillin, hydroxyzine, iodinated radio contrast media can also cause Baboon
syndrome.5

A case of SDRIFE due to Paracetamol was earlier reported.6 This is an uncommon skin reaction due to commonly used
medication. Hence, awareness is the key as it can be easily overlooked.

Health care professionals, patients/consumers are advised to closely monitor the possibility of the Ba-boon syndrome associated
with the use of paracetamol. If such events are encountered, please report to the NCC-PvPI either by filling of Suspected Adverse
Drug Reactions Reporting Form/ Medicines Side Effect Reporting Form for Consumer (http://www.ipc.gov.in) , Suspected
Adverse Drug Reactions Reporting app or by PvPI Helpline No. 1800-180-3024.

References:
1. "Acetaminophen". The American Society of Health-System Pharmacists. Retrieved 31st July 2017.
2. https://www.fda.gov/Drugs/DrugSafety/ucm239821.htm
3. www.who.int/medicines/publications/essentialmedicines/EML2015_8-May-15.pdf
4. Rapini, Ronald P.; Bolognia, Jean L.; Jorizzo, Joseph L. (2007). Dermatology: 2-Volume Set. St. Louis: Mosby. ISBN 1-4160-2999-0.
5. Akkari, H.; Belhadjali, H.;Youssef, M.; Mokni, S.; Zili, J. (May 2013). "Baboon syndrome induced by hydroxyzine.". Indian J Dermatol. 58 (3): 244.
Editors
6. Lugovic-Mihic L, Duvancic T, Vucic M, Situm M, Kolic M, Mihic J. SDRIFE (baboon syndrome) due to paracetamol: case report. Acta Dermatovenerol
Croat. 2013;21(2):113-7.
 MPS

Valbenazine
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Tardive dyskinesia (TD) is a movement disorder, characterized by oro-buccal-

lingual stereotypy, which manifests as akathisia, dystonia, tics, tremor, chorea,
myoclonus, or as a combination of different types of abnormal movements. TD
is caused by long term use of dopamine receptor antagonists such as typical or
atypical antipsychotics drugs and certain antidepressants (amoxapine) and
antiemetics (metoclopramide).1

The main intervention involves discontinuation of the causative agent (should

be slowly tapered), but TD can continue for years to decades even after
discontinuing the causative agent.2

Dr. Vikas S. Sharma Valbenazine is the first drug approved by USFDA on 11 April 2017 for the
MD Pharmacology Student
GMC, Nagpur, M.S. treatment of adults with TD. The recommended dose is 40 mg once daily
dr.vikassharma31@gmail.com initially, followed one week later by 80 mg once daily.3

Valbenazine is an oral, selective and reversible vesicular monoamine transporter 2 (VMAT2) inhibitor. [+]--
dihydrotetrabenazine is the active metabolite of valbenazine. Absolute oral bioavailability and t1/2 is ~49% and
1522 h respectively. it is highly (>99%) protein bound.3

In phase 3 (KINECT 3) trial, the least squares mean change from baseline to week six in Abnormal Involuntary
Movement Scale (AIMS) dyskinesia score was significantly greater in valbenazine 80 mg/day recipients and
valbenazine 40 mg/day recipients than in placebo recipients (-3.2 and -1.9 vs. -0.1; both p 0.002; with baseline
scores being 10.4, 9.8 and 9.9, respectively). Also at week six, the proportion of responders was significantly
greater in valbenazine 80 mg/day recipients and valbenazine 40 mg/day recipients than in placebo recipients (40.0
and 23.8 vs. 8.7% of patients; both p 0.02).4

Pooled analysis of placebo-controlled trials (KINECT, KINECT 2 and KINECT 3) shows most common adverse
events as somnolence, anticholinergic effects, balance disorders/fall, QTc prolongation (in CYP2D6 poor
metabolizers), headache, akathisia, vomiting, nausea and arthralgia.3

Valbenazine is also being tried for moderate to severe Tourette syndrome in children and adolescents and is
currently in phase 2 trial.5

Valbenazine is the first and only drug to be approved by USFDA for tardive dyskinesia.

References:
1. Waln O, Jankovic J. An update on tardive dyskinesia: from phenomenology to treatment. Tremor Other Hyperkinet Mov (NY). 2013.
doi:10.7916/D88P5Z71.
2. Aia PG, Revuelta GJ, Cloud LJ, et al. Tardive dyskinesia. Curr Treat Options Neurol. 2011;13(3):23141.
3. Neurocrine Biosciences Inc. IngrezzaTM (valbenazine) capsules: US prescribing information. 2017. https://www.fda.gov. Accessed 22 August 2017.
4. Hauser RA, Factor SA, Marder SR, et al. KINECT 3: a phase 3 randomized, double-blind, placebo-controlled trial of valbenazine for tardive dyskinesia. Am J
Editors
Psychiatry. 2017;174(5):47684.
5. Neurocrine Biosciences. Neurocrine announces initiation of phase II clinical study of VMAT2 inhibitor valbenazine in children and adolescents with Tourette
Syndrome [media release]. 2 Feb 2016. http://www.neurocrine.com/.
 MPS

LIST OF REGISTERED MEMBERS IN MPS

* *
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1 Dr. Shiva Murthy N 22 Dr. Meeta Burande

2 Dr. Sandeep Kaushal 23 Dr. Prashant Wadgbalkar

3 Dr. Melvin George 24 Dr. Mukundam Borah

4 Dr. Prakash B M 25 Dr. Syed Ziaur Rahman

5 Dr. Akash Gadgade 26 Dr. Paramjit Saini

6 Dr. Jhilli Basu 27 Dr. Deepti Sonawane

7 Dr. Malini S 28 Dr. Sapna Patil

8 Dr. Sanjeev Gupta 29 Dr. Akshay J K

9 Dr. Divyalasya TVS 30 Dr. Vikas S Sharma

10 Dr. K Laxmi Narayana 31 Dr. Mandeep Sarma Basistha

11 Dr. Phulen Sarma 32 Dr. Ranjana Kale

12 Dr. Pooja Roy 33 Dr. Preet Lakhani

13 Dr. Kanchan Gupta 34 Dr. Leena Chimurkar

14 Dr. Pavan Malhotra 35 Dr. Vidhushi Sharma

15 Dr. Anant Patil 36 Dr. Mirza Shiraz Baig

16 Dr. Pardeep Goyal 37 Dr. Lalit Kanodia

17 Dr. Neera Gupta 38 Dr. Shashi Kiran

18 Dr. Sonali Kirde 39 Dr. Priyadarshini

19 Dr. Deepak Langade 40 Dr. Ravi Chand D M

20 Dr. Ramesh Jagannathan 41 Dr. Divya Vijapur

21 Dr. Rahul
RameshRathod
Jagannathan 42 Dr. Bikash Medhi
 PHARMACOGENOMICS Workshop *
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LEARNING PROGRAM SCHEDULE

Day 1:
INTRODUCTION TO PHARMACOGENOMICS

Inaguration
Pharmacogenomics: Role in Pharmacotherapy
Techniques in pharmacogenomics
Sequencing
Pharmacogenomics case study
DNA Extraction demonstration
INTRODUCTION TO SEQUENCING

Past, present & future of sequencing

Introduction to NGS & Available platforms
NGS Application & choice of platforms
Discussion: A Case Study of Exome Sequencing
RAW DATA QUALITY CONTROL

Understanding raw data format (FASTQ

DAY 2
EXOME RE-SEQUENCING BEST PRACTICES
Best Practices For Experimental Designs
Introduction to Various Alignment Algorithms
Understanding Alignment File Formats
Analysis Design Strategies
EXOME RE-SEQUENCING ANALYTICS
Reference Genome Indexing
Understanding Sequence Alignment Tools and its
Parameters
Alignment quality Assessment and Visualization
Exome Capture Enrichment / Efficiency Analysis
Hands-On Practical Session For Processing Case Study Data
format)
Raw data quality control Fundamentals
Adapter trimming and Removing low quality
raw reads
Hands-On Practical Session For Processing
Case Study Raw Data
DAY 3
EXOME RE-SEQUENCING ANALYTICS -
CONTINUES
Introduction to Genomic Variations
Understanding Variation Data (VCF) Formats
Variation analysis to identify SNV / MNV /
SNP / MNPs / In-Dels
Variation analysis to identify SV and CNV
Variation Effect Prediction Analysis and Data
Visualization
SNP Frequency & Sample Comparisons as per
experimental design