The PUMBA Gazette - November 2010 Edition

8/8/2019 The PUMBA Gazette - November 2010 Edition

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The Editorial Address,

When social evils in India often revolved around children, be it

child marriage, child labour or female foeticide, Pandit

Jawaharlal Nehru, the first Prime Minister of independent India

loved children. A real visionary that he was, he had obviously

realized that the only way India could stride forward was bysecuring the lives of Indian kids. His birthday on 14

thNovember

is rightly celebrated as Childrens Day in India, hence this

edition.

The tie between a mother and her child is perhaps the

strongest of all, yet while building this bond, both have to go

through some of the most feeble and vulnerable phases of

their lives. As a believer of either science or mythology, one

cannot deny the fact that apposite care during the early

development of a new born, is vital for it to endure the

toughest of situations it may have to face later on in life.

From Mahabharata, where 7 infants were sacrificed before

Lord Krishna was born, till today, where India has amongst theworst infant mortality rates in the world, we have never had it

easy when it came to protecting the new borns.

In this edition of The PUMBA Gazette, we touch upon perhaps

the most delicate phase of human life- Infancy.

The news of pregnancy is always sweet for the parents-to-be.

But a bitter truth may await them if complications develop

during gestation. Gestational diabetes, unlike diabetes mellitus,

is not very well known but has been making its presence felt in

the recent past with increase in the number of cases. The

PUMBA Gazette team sought much needed information about

gestational diabetes by interviewing gynecologists from across

3 cities, namely Kolkata, Mumbai and Navi Mumbai, and Pune.The article included, focuses on awareness about gestational

diabetes, its existing tests for diagnosis and the treatment

adopted thereafter.

From the gestation period we move ahead with an article

about neonatal care. The article focuses on what has been

done and what needs to be done in India.

The Gazette then throws some light upon the innovations in

the field of biotechnology with an article about Stem cell

technology and its progress in the recent past. This is followed

by the news about recent happenings in the Biotechnology

industry.

The PUMBA Gazette team interviewed Mr. Vinod Narayanan

who manages the Export Operations at Phoenix Medical

Systems. Mr. Narayanan gave valuable insight into the niche

sector of Neonatal care industry in India. We wrap up the

November edition of the Gazette with PUMBA news that will

take you through the latest happenings in PUMBA.

I express sincere gratitude to the PUMBA Gazette team for

making my task easy by their sheer hard work and perfection.

Hope you enjoy reading the November edition as much as we

take pleasure in bringing it to you.

Sincerely yours,

Editor-in-chief:

Abhimanyu Tadwalkar (MBA-BT 2

nd

Year)The PUMBA Gazette Team

(The detailed project report shall be provided on enquiry.

Kindly send in your enquiries and feedback at

[email protected])

Contents Cover Story 3

--Gestational Diabetes: When pregnancy is

not quite sweet a news!

Article 4

--Neonatal Care: Protecting the earliest

whispers of life

InnovEra 5

-- Systematic Therapies

The Industry Buzz 6-- Traditional Knowledge Database

Library: AN AID AGAINST BIOPIRACY

-- Sanofi to launch reusable insulin pens

-- Glenmark completes all phase III trials of

CROFELEMER

Candid Talk 7

-- Mr. Vinod Narayan on Neonatal

Intensive Care Units

PUMBA News 8

Another feather in the cap

-- The Race Begins

-- Get your Running shoes on

Celebrating Children's Day
mailto:[email protected]


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Cover Story

GESTATIONAL DIABETES-

WHEN PREGNANCY IS NOT QUITE

SWEET A NEWS!

The uncharted facet in the spectrum of diabetes is gestational

diabetes mellitus. This condition is a form of diabetes which

affects pregnant women. The number of cases for gestational

diabetes mounting gradually made it the grounds for the

survey.

The hormones which are required for the development of

placenta block the action of insulin in the mothers body,

leading to a high glucose level. This condition is termed as

insulin resistance. When the body is unable to utilize glucose

due to insulin resistance, it results into gestational diabetes.

Gestational diabetes may affect the growth of the foetus.

Insulin does not cross the placenta like glucose. Extra blood

glucose passes from the mothers blood through the placenta

that gives the baby a high blood glucose level. It stimulates the

unborn baby's pancreas to make extra insulin in order to get rid

of the excess blood glucose. Since the baby gets more energy

than it needs to develop and grow, the extra energy is stored

as fat. This may lead to Macrosomia.

The study was conducted across 3 cities, namely Kolkata,

Mumbai and Navi Mumbai, and Pune. The study consisted of

interviewing gynecologists. The survey was conducted to

perceive the awareness about gestational diabetes, its existing

tests for diagnosis and the treatment adopted thereafter. Wealso endeavored to get knowledge about potential and

preferred course of treatment.

From the survey it emerged that, gestational diabetes was

observed in 2% of pregnancies. Majority of the doctors

interviewed were of the opinion that the level of awareness

about gestational diabetes among their patients was moderate.

They also commented that the level of awareness in case of

people belonging to lower economic strata of society was very

low. The most commonly used test for the diagnosis of

gestational diabetes was Glucose Tolerance Test (GTT) and the

other tests included Blood Sugar Level (BSL), Fasting PlasmaGlucose Test (FPG) and HbA1C test. The most common type of

GTT test done was oral GTT. 55% of the doctors were of the

opinion that diet cannot always control gestational diabetes.

However, the doctors in Kolkata were of the opinion t hat diet

has a major role to play in correction or prevention of the

condition.

The patients are required to take Insulin injections of

appropriate dosages; the dosage varying from case to case. The

most commonly prescribed insulin brand was found out to be

Mixtard (of NovoNordisk) followed by Glyciphage (of Franco

India), Novorapid (of NovoNordisk) and Huminsulin (of Eli Lilly).

Figure 1 TOMA of preferred tests for diagnosis of Gestational

Diabetes

In gestational diabetes, although the chances of the baby

becoming a diabetic later are very few, it can harm thedevelopment of the foetus, hence appropriate medications and

precautions need to be taken. 64% of the doctors interviewed

suggested that Oral drugs which are non-toxic to the baby;

preferably oral insulin should be introduced in the market. The

other suggestions included insulin pump, prick-free treatments,

nasal insulin and skin patches.

Figure 2. Most commonly Prescribed Brands

Initially, Metformin was not preferred by the gynecologists to

trim down the effect of elevated blood glucose level. This was

due to a speculated detrimental effect on the developing

foetus, but modern studies proved it incorrect. Thus, the

doctors took it as yet another potential form of medication

against gestational diabetes.

The companies should consider these views of the respondents

before launching new products in the market to treat

gestational diabetes.

Compiled by: Sumedh Purohit, Poorva Shinde, Firdaus Charanya

(MBA-BT, 2nd Year) Urmi Mukherjee, Vinay Pantulwar, Dhara Pujara,Neeraj Jadhav, Mrunmai Kulkarni, Harshal Kajale (MBA-BT 1

stYear)

1018

72

010203040

50607080

Blood Sugar Test FPG GTT

%ofRespondents

Most commonly used tests for Diagnosis

0

10

20

30

40

50

Huminsulin Novorapid Mixtard Glyciphage

Most commonly prescribed brands of Insulin

% of Respondents


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Article

NEONATAL CARE: PROTECTING THE

EARLIEST WHISPERS OF LIFE!A lack of skilled attendants at birth accounts for two million

preventable maternal deaths, stillbirths and newborn deaths

each year.

-Countdown to 2015 UNICEF Decade Report (2000-2010)

When a child is born, it certainly lights up the lives of many

around it. Hope, happiness and tears are all a part of childbirth.

The mother spends more than nine months of her life, nursing

her precious one inside. Therefore, it is only fair that her little

bundle of joy lives to have a full, happy life. However, a brightly

lit digital future that awaits us, miserably fails to meet this

simple expectation of a distraught new mother, for her

concerns do not touch us; she suffers in silence.

India has the unfortunate distinction of claiming more than a

quarter of the total newborn deaths in the world. Neonatal

Mortality is the death of a new born within a year of its birth.Although the Infant Mortality Rate (IMR) has gone down

considerably since the 1990s, the contribution of Neonatal

Mortality Rate (NMR) to IMR still remains high thereby

indicating that the reduction has been primarily due to a lower

post-natal mortality rate. The current NMR is approximately 44

out of every 1000 live births (44/1000), accounting for almost

two-thirds of infant mortality and one-half of under-5-years

mortality.

The NMR is also one and a half times higher in rural areas than

in urban areas. There is scientific evidence to suggest that

NMR, and hence IMR, can be significantly reduced by higherliteracy (especially female literacy) and better primary

healthcare services.

The major causes for neonatal deaths are prematurity/low

birth weight, birth asphyxia/injury and infection (sepsis,

pneumonia, diarrhoea). Around 33 percent of all neonates in

India are low-birth-weight (LBW), weighing less than 2500g.

Countdown to 2015

Nearly 50 percent of women in 68 countries mostly in sub-

Saharan Africa and South Asia give birth without a trained

nurse, midwife or doctor, according to the report, Countdown

to 2015, which tracks maternal health and newborn and child

survival during the decade from 2000 to 2010.

The report shows that only 10 countries have increased the

rate of skilled care at childbirth by 10 per cent or more since

1990; 11 countries have made no progress at all. And we make

it to the unwelcome list of these 11 countries!

What have we done?

The Government of India has integrated the Child Survival and

Safe Motherhood (CSSM) Programme since 1992 which aims to

provide essential newborn care, immunization, appropriate

management of diarrhea, acute respiratory infections, etc. for

children, as well as complimentary services to mothers.

The National Neonatology Forum is a non-governmental,academic organization, which has contributed by undertaking

country-wide training programs in neonatal care. In addition,

the Reproductive and Child Health Program II (RCH-II),

Integrated Management of Childhood Illness (IMCI) and

Integrated Management of Neonatal and Childhood Illness

(IMNCI), as well as the broader Indian National Rural Health

Mission launched in 2005, all aim to achieve a further,

significant reduction in the IMR, especially in the high IMR belt

that traverses the states of Orissa, Madhya Pradesh, Assam,

Bihar, Uttar Pradesh, Haryana and Rajasthan.

There has been a steady increase in the number of newborn

nurseries in the country, even though the total number of suchunits is still quite small. These nurseries still require adequate

infrastructure and staff including neonatal nurses, as well as

intensive care units.

What remains to be done?

While it is heartening that the Government of India has

responded by launching various programs to improve neonatal

care, it is clear that to make an impact in these states, specific

components of ante-natal, intra-natal and post-natal services

must be strengthened. Such services include the promotion of

timely and adequate infant immunization, growth monitoring,

care during diarrhoea and acute respiratory infections,

adequate breast-feeding and weaning supervision. To achieve

this goal, the existing primary healthcare system must be made

more accountable. It is also of extreme importance that

certain measures are taken to improve the awareness of

mothers and families regarding the care of normal and LBW

infants and the recognition of early signs of sickness.

While the total number of deaths in under-five children has

declined, the percentage of infants who die during the first 28

days after birth has increased in recent years, the report finds.

On a brighter note, provision of insecticide-treated bed nets (to

prevent malaria) and prevention of mother-to-child

transmission of HIV have been rapidly scaled up in many

countries. The success of these shows what can happen when

commitments are made and fulfilled.

UNICEF is emphasizing on reduction of under-five infant

mortality in their Millennium Development Goals 4, which

have to be met by 2015. These can only be achieved if

adequate funds are devoted. However, with the current trends

there will be a global gap of $60 billion in the funds. While a

number of programmes have been initiated to address the

issue of child health and mortality, all of them have only been

partially successful. It is evident that a lot more efforts have tobe taken not only by these organizations, but also by the

common people to work towards the improvement of neonatal

care.

We need more such commitments, with a focus on political,

economic, cultural and technological solutions to the crisis in

maternal and newborn health.

Compiled By: Nandini Sengupto and Neeraja Namboodiri (MBA-BT 2nd

Year)


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InnovEra

SYSTEMATIC THERAPIES

Stem cell biology is a promising and emerging field of the life

sciences. The potential of stem cell technology to develop

therapy for many untreatable diseases through cellular

replacement or tissue engineering is widely recognized.

Keeping in view its potential therapeutic applications, bothbasic and translational research are being promoted by the

departments in various institutions, hospitals and the industry.

Stem cell research is one such domain that has drawn

significant contribution from both public and private sectors.

The global market for stem cell therapy is expected to be

around US $ 88.3 billion by 2014 at CAGR OF 24.2% FOR 2009-

2014.Stem cell market in India has grown substantially and it is

estimated that India will have $2.4 billion market which is 2%

of total global market with highest CAGR of 27%.

Stem cells feature two important characteristics that make

them distinct from other cells. The first distinctive

characteristic is their ability to renew themselves through cell

division and the second is their capability of being induced to

become tissue or organic-specific cells with specific functions.

This capability of stem cells is used in treating various disorders

like Parkinsons disease, Alzheimers disease, diabetes, various

cardiac disorders, various types of cancers, orthopedics,

various ischemia disorders, etc. Stem cell research holds great

promise for improving human health by control of

degenerative disease and restoration of damaged organs whichare injured due to various injuries.

In treatment of Parkinsons disease, mesenchymal stem cells

are transplanted in brain through keyhole surgery. These stem

cells then multiply and thereby regenerate the damaged areas

of brain which leads to reactivation of brain resulting in

recovery from disease. The stem cells slow down or stop

further deterioration caused by the disease and it can also

reverse the effects of disease. The therapy is still considered

experimental as it is being tested in clinical trials and is not

available as standard medical treatment.

Stem cell therapy is also used in treating various types of

cancer. Stem cell treatments for cancer provide hope for many

patients suffering from some form of this disease. In fact, they

are already being used in certain types of cancer such as

leukemia. For years, stem cells have been used for treating

leukemia because it helps to restore the white and red blood

cells after high doses of radiation and chemotherapy are used.

They help because, stem cells have the ability to grow into

other cells, which means they can be used to replace damaged

and unhealthy cells with new healthy ones. Scientists believe

that these new healthy cells could be used as stem cell

treatments for cancer.

Doctors are using types of stem cell therapy for Alzheimers

already with excellent results thats paving the way for a

brighter future. Adult stem cell research has revealed some

possible cures for this condition. This process involves

collecting bone marrow from the patient that will be taken

from the hipbone. This bone marrow will be processed and

then the cells will be re-implanted back into the patient a few

days later. The cells that are placed back into the body have the

ability to transform into new cells that can replace or

rejuvenate the damaged nerves and tissues that cause this

disease. As a result, Alzheimers is slowed down considerably

and in some cases, it may stop the progression all together.

Even though the stem cell therapy may seem so promising,

there still many arguments going on whether stem cell therapy

should be used or not. The most debated issue is whether

using embryonic stem cells is ethical or not. One concern of

treatment is the possible risk that transplanted stem cells could

form tumors and have the possibility of becoming cancerous if

cell division continues uncontrollably.The challenges in this

area also include availability of human resource of desired

expertise; adequate infrastructure; interdisciplinary network of

researchers and clinicians for theme based research;

appropriate regulatory mechanisms; well defined basic

research leading to clinical/translational research, focused

centres and institutions.

But the benefits that stem cell therapy offers are more than

the controversies around it. It holds a great promise of

providing a better human life.

Compiled By: Hitesh Patil (MBA Biotechnology 2nd Year)


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The Industry Buzz

TRADITIONAL KNOWLEDGE

DATABASE LIBRARY: AN AID AGAINST

BIOPYRACY

The importance of the Traditional knowledge has once again

come into light. The piracy of the Traditional Knowledge andusing it for getting patents, commercializing the product, is also

called as Biopiracy. The US patent officers have planned a visit

in coming month to understand the Indian Traditional

Knowledge database that is available online.

A recent case of Biopiracy was reported and a suit was filed

against Colgate- Palmolive a FMCG giant in USA, for a patent

granted to them for a red herbal dentifrice. Some of the

companies in India including Dabur India and Shree Baidyanath

Ayurved Bhavan pvt Ltd have been selling the same

formulation for years in India under the brand name of Lal dantManjan.

There has been a strong opposition posted by these companies

with a claim that the red dentifrice has been known as

traditional knowledge in India since ages and thus cannot be

patented.

India and USA had previously signed an agreement to avoid the

misuse of traditional knowledge and wrongful issuance of

patents regarding same. However it could not be worked upon

because of operational difficulties.

Indian government in association with CSIR has started online

listing of traditional formulations known as Traditional

Knowledge Database Library. Till now the database contains 2,

23,000 medicinal formulations based on Ayurveda, Unani,

Siddha and Yoga systems. 28 patents granted before the

introduction of this database were cancelled by European

Patent Office after the introduction of the database. It is

estimated by TKDL that almost 2000 wrong patents can be

cancelled if they existed in traditional knowledge. A thorough

understanding of US Patent process by India and the sameunderstanding of TKDL by US authorities is needed.

The USPTO has expressed a concern over attempts of

traditional knowledge being patented with the removal of

knowledge from the public domain.

The step of TKDL is considered to be a positive step by the

industry people. According to them the TKDL would certainly

ensure that wrong patents are not issued and thus protection

of the traditional knowledge.

SANOFI TO LAUNCH REUSABLE

INSULIN PENSSanofi- Aventis is all set to roll out a very unique product in the

Indian market. The French Drug maker is launching a reusable

insulin pen in the Indian market in the coming next quarter 2 of

the year 2011.

The devise is in the advanced stage of development and will

soon be launched. According to the company it is totally an

Indianised version of the devise. The target market for the

company will be rural market. The reusable pen will be

launched keeping the focus on the rural market only. The

company is expecting one third of the sales to come from the

rural market. One of the factors is making the drugs available

to the Indian rural population at an affordable price.

The company is also ready to launch a cream of the Combiflam.

Combiflam is an OTC drug currently sold as tablet in the Indian

market as painkiller.

GLENMARK COMPLETES PHASE III

TRIALS FOR CROFELEMER.Glenmark, the Mumbai based drug maker has finally

completed the phase III trials of a new drug called Crofelemer.

It is a drug to be used against HIV associated Diarrhoea.

Glenmark has developed the drug in association with two other

foreign companies, namely Napo pharmaceuticals and SalixPharmaceuticals. Now company is lobbying for getting the

regulatory matters completed and making a way for the launch

of the drug. According to the sources the drug should be in

market in the year of 2012.

The company has all the rights to manufacture the active

ingredient. Glenmark will be the only supplier of this active

pharmaceutical ingredient. Also the marketing and distribution

rights remain with the company only for the drug to be

launched in total 140 countries.

Compiled by:Sumantsinh Girase (MBA Biotechnology 2nd Year)


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Candid Talk

Mr. VINOD NARAYAN ON NEONATAL

INTENSIVE CARE UNITS

Mr. Vinod Narayan manages the

Export Operations at Phoenix

Medical Systems-India which is thelargest Neonatal equipment

manufacturer. He has expanded the

overseas market for Phoenix

products to all major markets of

Latin America, Far East, Middle East,

CIS countries and European

countries.

Q.1. India accounts for more than a quarter of neonatal

mortality but the irony is that the Neonatal Care market is still

in the embryonic stage in India. What is your take on this?

The new born health challenge faced by India is bigger than

that experienced by any other country. Each year, 20 percentof the worlds infants an awesome 26 million are born in

this vast and diverse country. Of this number, 1.2 million die

before completing the first four weeks of life, a figure

amounting to 30 percent of the 3.9 million neonatal deaths

worldwide. India is home to the highest number of both births

and neonatal deaths of any country in the world. Neonatal

health among urban poor communities is emerging as a serious

problem. Most of the Indian neonatal mortality is in the rural

area and due to the cost involved in this, the advanced care

cannot be provided to all. The government is trying to set up

hospitals with advanced equipments but that would take time

and investment.

Q.2. What are the equipments available for neonatal care in

India and what additions are needed in Indian neonatal care

equipments market?

Indian markets even though not very well in the race with the

trends but still it is always updated about the new

developments in the segment and all new technologies are

always within reach the; only constraint being the fact that

importing material increases the cost and hence new

technologies take time to be introduced in the Indian Market.

The current Equipments available in this segment are:

Q.3. Do neonatal intensive care units (NICU) have a role in

developing countries like ours, taking into consideration the

fact that majority of babies have no access to primary care and

neonatal intensive care is among the more expensive services

that any health care system can provide?

The major factors determining the need for neonatal intensive

care services are population, birth rate, and proportion of live

births that are VLBW (i.e. less than 1,500 gm). The average stay

of a VLBW baby in the intensive care is around three weeks, soif we take 100 percent occupancy on all 365 days, we need

over 51,000 NICU beds committed to the care of these babies.

Data from developed countries show that VLBW infants

represent approximately 1.3 percent of births, but their need

for intensive care consumes 7 out of 10 intensive days. If we

take these factors into consideration, we may need over

72,000 neonatal NICU beds for the country. The existing

neonatal intensive care beds in the country at accredited units

today are less than 2,000, or less than three percent of the

requirement. So there is the need, but as said before the cost

of these services are high. Here the role of government and

private sector is important. The government should takemeasures to provide these services to common man at

reasonable cost and the primary care should always be given

the first priority. The private sector has equal role in providing

these services at reasonable cost.

Q.4. How important is it in maintaining customer relationship in

neonatal care equipment segment and what efforts go into

maintaining it?

If equipment is trouble free, you have a happy customer who

will come back to you for his/her future requirement and

happy customer means healthy consumer; this is what all

organization strive for in this segment. Providing good service

is imperative. There could be any kind of problem with theequipment and that may harm either the newborn or the

reputation of your customer therefore being in constant touch

with the customer and attending breakdown calls in the

shortest time is of utmost importance.

Q.5. How important is the technical expertise of the sales force

in the neonatal care segment?

Neonatal Care involves highly sophisticated instruments and

the operation of this instrument should be well known to the

sales force. They should be technically qualified to understand

the working and operations of the instruments. An under

qualified sales person who doesnt have knowledge about theproduct, either wont be able to sell the product or may create

a big, life threatening blunder. So the sales force should be

technically sound and understand the complete working of the

product.

Q.6. Analysis of a top market research firm shows that the

global market for neonatal diagnostics and monitoring is

estimated to reach $161.2million in 2012. What do you think

would be Indias contribution to this market?

Indias Contribution to this market by 2012 depends on the

international players coming to India and developing the

market. The potential is huge but the only requirement is the

proper harnessing of the available potential by both Domesticand International firms.

Compiled by:Tushar Pareek (MBA Biotechnology 2nd Year)

Comprehensive Infant Care

Center

Neonatal Open Care System

Infant Radiant Warmer Neonatal Intensive Care

Incubator

Neonatal Transport Incubator Neonatal Phototherapy Unit

Electronic Baby Weighing

Scale

Open Care Warmer

Delivery Table Resuscitating Bags

Nasal CPAP Infant Bassinets

Phototherapy Unit (PT-104) LED Phototherapy

Apnea Monitor Oxy Monitor


8/8

The PUMBA News

ANOTHER FEATHER IN THE CAP

Dr. (Capt.) C.M. Chitale, former Dean, Faculty of Management

Studies, University of Pune, has been appointed as the new

Head of Department of PUMBA. Adding to his list of

achievements, he has also been nominated by Maratha

Chamber Of Commerce, Industries and Agriculture (MCCIA) on

various committees as

Special Invitee on Executive Committee

Co-Chairman on Education Committee

Member of HR Committee

Dr. (Capt) C. M. Chitale has always been a source of inspiration

and treasure of knowledge. The students will get to learn a lot

from his experiences in various fields.

THE RACE BEGINS...

The placement season for PUMBA MBA-BT course has

commenced from the month of November .The major

recruiters are Pharmaceutical, Biopharma and Biotech

industries while the other major recruiters being Biosuppliers,

Consultancies, Agriculture and Market Research firms from all

over India.

With optimism in the campus, students from various

backgrounds are eager to venture into the vast expanse of the

corporate.

A great placement season is expected ahead.

THE RUN FOR A CAUSE

25th

Pune International Marathon was organized on Sunday, 5th

December 2010. PUMBA has been a regular participant in Pune

International Marathon for the past few years and has been

regularly winning prizes like Best academic institution, Most

creative attire and Best slogans.

This year too, PUMBAites participated in the AIDS Charity Run

with zeal. More than 150 PUMBAites from first as well as

second year ran for a cause. Dr. (Capt.) C.M. Chitale, the Head

of the Department, enhanced the enthusiasm of the students

with his motivating speech. On 4th

December, PUMBAites

conducted an AIDS awareness campaign in the University

Campus and collected messages of professors and students for

the AIDS patients. Large banners with these messages were

then displayed at the Jawaharlal Nehru Stadium where the

marathon concluded. PUMBA won the Best Theme Award for

their AIDS awareness campaign.

Documents

The PUMBA Gazette - November 2010 Edition