QualPharma December 2020

Only for Pharma People

QualPharma

Volume 3, Issue 12

December 2020, 30/-

The Learning and Development Journal

Patent

Opposition

in India

OXFORD

Technology

VACCINE

UPDATE

A Macro Insight to a

Micronutrient

METHYLCOBALAMIN

Management of

co-infection of COVID-

19 with other

seasonal epidemic

prone diseases

Dilly dallying in notifying

METHYLCOBALAMIN

lays bare red tapism in

key apex Institutions like

FSSAI and ICMR

Learn to Change

Change to Succeed

CORONA

VACCINE

RACE

Chairman – MSCDA LTD , AIOCD LTD & President The

Maharashtra State Chemist & Drug Association

Editor–in–chief Ms Anshu Yadav

Senior Copy Editor Ms Ragini Arya

Editor Dr. Sanjay Agrawal

Consulting Editor M.D Parasha

Image Designer Amaresh K A-Cube

Graphics

Advisory Board

Dr Sanjay Agrawal

Mr. Shiven Yadav

Dr Avinash Shankar

Mr Jagdev Singh

Mr Subhash Chandra

Ms Sudha Agrawal

Ms Anaisha Singh

Ms Shanvika Singh

Design & Publications

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FROM THE DESK OF

EDITOR - IN – CHIEF

Dear Readers,

There has been lot of confusion like whether Methylcobalamin

is banned or approved, what is the per usage serving

value of the product etc. Methylcobalamin is widely

marketed in the country as a drug for chronic neurological

disorders with a recommended dietary allowance of 2000

mcg intramuscular but as per FSSAI it is detrimental for

patients when used above 1 mcg for prevention and disease

management.

At present there is no clarity on tolerable upper limit

(TUL) along with confusion on RDA value of methylcobalamin.

This is all the more contradictory considering

that ICMR and National Institute of Nutrition (NIN) have

recently issued another report which have different stipulated

RDA values of methylcobalamin and estimated average

nutrient requirements for Indians. QualPharma fully

endorse that the RDA and per usage entity must be separated

entity for nutraceuticals and FSSAI should review it

technically.

Coming back to our edition we have SHINDE JAGAN-

NATH SAKHARAM Chairman – MSCDA LTD ,

AIOCD LTD & President – The Maharashtra State Chem

& Drug Association (p16)on our cover page and profile of

Mr RAJIV SINGHAL General Secretary of AIOCD

(p18). You may keep yourself updated on Corona stories,

medical and marketing articles and zodiac prediction from

our expert.

You may know more about us through http://

www.qualpharma.in/. STAY UPDATED STAY

BLESSED and do not forget to follow up our blog https://

qual-pharma.blogspot.in/ to receive regular interesting updates.

(ANSHU YADAV)

December Contents

QA/REGULATORY

Dilly dallying in notifying METHYLCOBALAMIN

lays bare red tapism in key apex Institutions like

FSSAI and ICMR

MEDICAL

A Macro Insight to a Micronutrient

METHYLCOBALAMIN

5

9

PERSONALITIES

SHINDE JAGANNATH SAKHARAM—Chairman

– MSCDA LTD , AIOCD LTD & President – The

Maharashtra State Chemist and Drug Association

RAJIV SINGHAL—General Secretary of AIOCD 16

HEALTH AND WELLNESS

Management of co-infection of COVID-19 with

other seasonal epidemic prone diseases

MARKETING

Learn to Change, Change to Succeed 24

14

20

PATENT AND TRADEMARK

Patent Opposition in India 27

CORONAVIRUS SPECIAL

Corona Vaccine Race 32

OXFORD TECHNOLOGY 35

Two Vaccines by February in India 36

VACCINES UPDATE 36

No to Remdesivir for COVID advices WHO 37

Covaxin Technology 37

Research says Covid patients are infectious for first

nine days from onset of infection

37

NEWS REVIEWS

PM Modi Warns Of Possible Side-Effects 41

Ayurvedic doctor’s authorized to do surgery 41

ZODIAC PREDICTION 43

QualPharma *Dec 2020* , Vol.3 ISSUE 12

QA & REGULATORY

Dilly dallying in notifying METHYLCOBALAMIN

lays bare red tapism in key apex

institutions like FSSAI and ICMR

Our Fight Continues

Omission of key micro-nutrients like methylcobalamin

in Food Safety and Standards

Authority of India (FSSAI) health

supplement regulations 2016 as well as the

ongoing methylcobalamin ban have not

only led to a chaotic scene in the industry

but also laid bare red-tapism of key institutions

like the Food Safety and Standards

Authority of India (FSSAI) and the Indian

Council of Medical Research (ICMR), so

much so that the pharma experts have outrightly

defied the ban and asked for clarity

from the Union Health Ministry, Union

Ministry of Chemicals and Fertilizers &

Drugs Controller General of India (DCGI).

Both FSSAI and ICMR have been adamant

in their approach wherein FSSAI has not

responded responsibly as yet on the key

issue of revoking the ban on methylcobalamin.

However, under the current premise and

having bore the brunt of the insensible behavior

of the authorities, a recent representation

has been made to Union Ministry of

Chemicals and Fertilizer. The consultants

have once again recommended DCGI to be

given the sole authority for implementation

of nutraceutical policies and regulations,

citing FSSAI as a toothless body. Ten years

ago, nutraceutical was under DCGI itself.

Nutraceutical and drug consultants have

alleged that FSSAI has been turning a blind

eye to the contentious issues raised with

reference to RDA values of Vitamin C and

other micronutrients like methylcobalamin,

which are vital for boosting immunity, mental

health and other co-morbid chronic ailments

in the crucial juncture of COVID-19

pandemic.

Prime Minister Narendra Modi has recommended

1000 mg of Vitamin C for prophylactic

use against COVID-19 whereas its

RDA is suggested as only 40 mg due to poor

interventions by apex and responsible authorities

like ICMR, FSSAI and DCGI.

Dr Sanjay Agrawal

Dr Agrawal has actively worked in pharmaceutical

and related industries for more

than 35 years and started this firm Pharmaceutical

Consultants and Inventor in

2005. He is Editor-in-Chief of renowned

IJM Today . Dr Sanjay Agrawal is the

illustrious member of the National Geographic

Society and ex-member of scientific

committee of IDMA. He had received

various awards for his valuable support

and contributions in Healthcare and pharmaceutical

sector Dr. Agrawal obtained his

postgraduation in Biochemistry from prestigious

institution. He has worked with

many International and national Pharmaceuticals

companies. Dr. Sanjay Agrawal

is the patent holder of atleast 40 research

formulations.


QA & REGULATORY

Methylcobalamin is an essential nutrient

and is required to treat vitamin B12 deficiency

in people with pernicious anaemia,

diabetes and other conditions as well. It is

important for the brain, nerves and for

the production of red blood cells (RBCs).

Since, source of methylcobalamin is from

non-vegetarian products hence supplementation

with methylcobalamin becomes

very essential, specially for Indians.

Therefore, when a supplement is

taken prophylactically, it must at least be

of the therapeutic dose.

There has been lot of confusion like

whether Methylcobalamin is banned or

approved, what is the per usage serving

value of the product etc. Methylcobalamin

is widely marketed in the country as

a drug for chronic neurological disorders

with a recommended dietary allowance

(RDA) of 2000 mcg intramuscular but as

per FSSAI it is detrimental for patients

when used above 1 mcg for prevention

and disease management.

Gujarat FDCA Commissioner, Dr H G

Koshia, has been quoted as saying that

there is a ban on methylcobalamin pan-

India and the states need to follow it as

per FSSAI directive. The Central Drugs

Standard Control Organisation (CDSCO)

had urged the FSSAI to take action

against Gujarat-based manufacturers for

manufacture and sale of methylcobalamin

meant for therapeutic intervention which

is in contravention of the norms. In view

of the same, it has been recommended on

priority basis to instruct drug inspectors

and food safety officers to launch surveillance

drives against various brands of

products containing methylcobalamin

being manufactured and sold under

FSSAI license.

On the other hand Former CEO of FSSAI

Pawan Agrawal had promised in December

2019 that methylcobalamin has been

approved by their scientific committee

and in due course of time will be included

in the gazette. But it's been almost a year

without any progress regarding the inclusion

of methylcobalamin in the gazette.

On January 7, 2020, FSSAI issued a notification

regarding RDA of vitamin B12

wherein it was mentioned as 1 mcg without

mentioning which type of vitamin B12

like methylcobalamin, adenosylcobalamin,

hydroxycobalamin or cyanocobalamin.

The dual standards of FSSAI can also be

seen by the presence of already FSSAI

approved brands available with 1500 mcg

qty/per serving. Rejunex CD3 of Intas is a

FSSAI approved product containing 1500

mcg methylcobalamin. Some of the

widely sold brands are Locopen capsule,

Neugaba M 75 capsule, Nervup

500 mcg injection, Nuroz Forte,

Nurofine-2500 injection, Actavis

2500 injection, etc. There are more

than half a dozen other brands with

the same formula.

Until and unless FSSAI does not inform

the industry that methylcobalamin is approved,

there is no value of prescribing

RDA value for the same. Surprisingly the

mails which we have received from FSSAI

mention the same RDA for both methylcobalamin

and cyanocobalamin. It is

noteworthy that here the discussion is

about 'per serving' usage value which the

manufacturer can refer to and not the

RDA value for a healthy person.

At present there is also no clarity on tolerable

upper limit (TUL) along with confusion

on RDA value of methylcobalamin.

This is all the more contradictory considering

that ICMR and National Institute of

Nutrition (NIN) has recently issued another

report which has different stipulated

RDA values of methylcobalamin and

estimated average nutrient requirements

for Indians.

It is well-known that Vitamin B12 is present

majorly in non-vegetarian sources.

Here it is noteworthy that in a country

such as US wherein major population

consume non-vegetarian products, the

RDA for methylcobalamin is 2.4 mcg

whereas, in India, most of the population

consumes vegetarian diet, but the RDA

set is a mere 1 mcg.

According to industry person Anshu

Yadav, “It is now amply evident that the

issue about taking action on methylcobalamin

manufacturers is totally uncalled

for. Reason being that the letter issued by

FSSAI deputy director to Gujarat state

drug control department to take action on

methylcobalamin manufacturers without


QA & REGULATORY

any intimation to the then FSSAI CEO

Pawan Kumar Agarwal indicating lobbying

and malafide intent to discourage

industry and to satisfy vested interests.”

Pharma experts have also voiced concerns

that when methylcobalamin has been

approved by CDSCO up to 2000 mcg then

why is FSSAI recommending only 1 mcg,

which is of no use. DCGI has approved

2,000 mcg of methylcobalamin even in

injectable form and respective brands are

available as physicians recommend methylcobalamin

based on the patient's

medical condition. It is pertinent that

other countries have kept RDA and 'per

serving' usage value as separate entities.

This concept is currently being goofed up

by FSSAI in India.

"There is an urgent need for inclusion of

methylcobalamin in the gazette and reviewing

the RDA for nutraceutical products,

by not forgetting that products are

already available at higher concentrations",

informs pharma expert Anshu

Yadav. She further adds, "that until and

unless FSSAI does not inform the industry

that methylcobalamin is approved,

there is no value of prescribing RDA value

for the same."

We as stakeholders of pharma fraternity

have appealed to the Centre to delegate

the responsibility of nutraceutical division

to the DCGI in our recent representation

made to Union Ministry of Chemicals

and Fertilizers. Ten years back

nutraceutical was under DCGI only.

Similar case is with Vitamin C, Prime

Minister Narendra Modi has also recommended

1000 mg of Vitamin C as prophylactic

use against COVID-19 whereas its

RDA is 40 mg due to poor interventions

from apex and responsible authorities

like ICMR, FSSAI and DCGI.

~By Dr Sanjay Agrawal



MEDICAL

A Macro Insight to a Micronutrient

METHYLCOBALAMIN

India's life expectancy has more than doubled

and infant mortality, halved in the

last fifty years. The extent of progress on

economic fronts has also been enormous.

India is knocking the door for a permanent

position in the United Nations and is one

of the few atomic power countries in the

world. However, paradoxically, we have

the highest number of malnourished people

in India. With one sixth of the global

population residing in India, one third of

about two billion people suffering from

vitamin and micronutrient deficit are in

India.

Vitamin B12 Deficiency: A forgotten

Illness

Currently, vitamin B-12 deficiency has

become an almost forgotten illness or is

treated as a less serious diagnosis. We

need to expand our horizons in our understanding

of vitamin B12, but one thing is

certain that vitamin B12 deficiency is extremely

common in the Indian subcontinent.

The insight into vitamin B12 metabolism

came from the western literature, and

since then India has adopted their guidelines

on diagnosis and management. But,

we can’t be farther away than this from the

truth. We need to understand more about

vitamin B12 with respect to Indian context

especially now that there is evidence

that vitamin B12 deficiency is more

common than was previously believed.

Why Vitamin B12 Deficiency in India?

While vitamin B12 deficiency in the West

is seen more commonly in the elderly and

is due to malabsorption, in India it affects

all age groups due to following factors:

Diet: As compared to a western diet, there

is much lesser vitamin B12 in the average

Indian diet, which is mostly vegetarian.

Even the non-vegetarians do not consume

meat regularly as the westerners do. The

usual habit is that they take meat only

once a week at the most. Most nonvegetarians

are non-vegetarians only because

they might occasionally consume

some fish or egg. Thus, there is a lack of

regular consumption of meat and if at all

Sushmita Chatterjee Kuswa

Mrs. Sushmita Chatterjee Kuswa is currently

working as a Senior Manager in one

of India’s leading pharmaceutical company.

She has an expertise of 14 years in

Scientific as well as Regulatory Affairs.

She has excelled in MSc Biophysics with

Distinction from Mumbai University as

well is Distinction holder in Business Management

Studies which she has completed

from Welingkar Institute of Management,

Mumbai. She has graduated with double

major subjects in Microbiology and Biochemistry

from the prestigious St. Xavier’s

College, Mumbai.

Along with excelling in academic and extra

-curricular activities during her education

years, she has always been an ardent

reader and also has a flair for writing.


MEDICAL

consumed, is often in the fried form resulting

in loss of B12 and producing even

toxins such as nitrosamines. Thus we

observe that both vegetarians and

non-vegetarians in India are at risk

of Vitamin B12 deficiency.

Malabsorption: There are several factors

which could potentially cause malabsorption

of Vitamin B12.

A. Defective release of cobalamin

from food

• Gastric achlorhydria

• Partial gastrectomy

B. Inadequate production of Intrinsic

Factor

• Total gastrectomy

C. Disorders of terminal ileum

• Tropical and nontropical sprue

• Intestinal resection

• Granulomatous diseases

D. Competition for cobalamin

• Bacteria (blind loop syndrome)

E. Drugs

• Colchicines, neomycin, metformin,

carbamazepine, chloramphenicol,

proton pump inhibitors, such as

omeprazole and lansoprazole and

Histamine H2 receptor antagonists,

used to treat peptic ulcer

disease e.g. cimetidine, famotidine,

and ranitidine.

Older adults: Atrophic gastritis, a condition

affecting 10%–30% of older adults,

decreases secretion of hydrochloric acid

in the stomach, resulting in decreased

absorption of

vitamin B12.

Decreased hydrochloric

acid

levels might

also increase

the growth of

normal intestinal

bacteria

that use vitamin

B12, further

reducing

the amount of

vitamin B12

available to the

body. As a result,

the Institute of Medicine (IOM),

USA, recommends that adults older than

50 years obtain most of their vitamin B12

from vitamin supplements or fortified

foods. However, some elderly patients

with atrophic gastritis require

doses much higher than the RDA to

avoid subclinical deficiency.

Individuals with pernicious anaemia:

Pernicious anaemia, a condition

that affects 1%–2% of older adults, is

characterized by a lack of intrinsic factor.

Individuals with pernicious anaemia cannot

properly absorb vitamin B12 in the

gastrointestinal tract. Pernicious anaemia

is usually treated with intramuscular vitamin

B12. However, approximately 1% of

oral vitamin B12 can be absorbed passively

in the absence of intrinsic factor,

suggesting that high oral doses of vitamin

B12 might also be an effective

treatment.

Individuals with gastrointestinal

disorders: Individuals with stomach

and small intestine disorders, such as

celiac disease and Crohn’s disease, may

be unable to absorb enough vitamin B12

from food to maintain healthy body

stores.

Pregnant and lactating women who

follow strict vegetarian diets and

their infants

There is some evidence that the absorption

of vitamin B12 may increase during

pregnancy. Serum total vitamin B12 concentrations

begin to decline early in the

first trimester. There were further decreases

through the sixth month to about

half of non-pregnancy concentrations.


MEDICAL

Vitamin B12 crosses the placenta during

pregnancy and is present in breast milk.

Exclusively breastfed infants of women

who consume no animal products may

have very limited reserves of vitamin B12

and can develop vitamin B12 deficiency

within months of birth. Undetected and

untreated vitamin B12 deficiency in infants

can result in severe and permanent

neurological damage.

The Academy of Nutrition and Dietetics

recommends supplemental vitamin B12

for vegans and lacto-ovo vegetarians during

both pregnancy and lactation to ensure

that enough vitamin B12 is transferred

to the foetus and infant. Pregnant

and lactating women who follow strict

vegetarian or vegan diets should consult

paediatrician regarding vitamin B12 supplements

for their infants and children.

Transfer to the Foetus. The serum B12

concentration of the new-born is twice

that of the mother, decreasing to adult

concentrations at about 6 to 7 months

postpartum. The placenta concentrates

B12, which is then transferred to the foetus

down a concentration gradient. Foetal

and maternal B12 serum concentrations

are quite strongly correlated.

It appears that only newly absorbed

B12 is readily transported across

the placenta and that maternal liver

stores are a less important source of the

vitamin for the foetus. This implies that

current maternal intake and absorption

of the vitamin during pregnancy

have a more important influence

on the B12 status of the infant

than do maternal B12 stores.

Lactation: Current maternal intake

of the vitamin may have an important

influence on secretion of the

vitamin in milk. In several studies of

infants with clinical signs of vitamin B12

deficiency caused by low maternal intake

or absorption of the vitamin, maternal

plasma concentrations of the vitamin

were found to be normal or low normal,

suggesting that maternal B12 stores

are less important than current maternal

intake.

The RDA Enigma

The Recommended Dietary Allowance

(RDA), by definition, is designed to provide

dietary guidance for healthy individuals.

An important consideration is

whether the recommended intake is adequate

to prevent the biochemical disturbances

that were recently recognized to

be widespread and sometimes associated

with subtle but important clinical disorders,

rather than preventing overt disease

as used in the design for establishing

RDA.

The intake of micronutrients in daily diet

is far from satisfactory and largely less

than 50% RDA is consumed by over 70%

of Indian population. Moreover, the loss

due to micronutrient deficiency costs

India a huge loss in terms of productivity,

illness, increased health care costs and

death.

As per National Institute of

Health (NIH),

dietary supplements against

vitamin B12 deficiency can also

contain methylcobalamin and

other forms of vitamin B12.

Need to Revisit the RDA Values with

Changing Times

In Western countries: It is imperative

to take cognizance that the current RDA

value of vitamin B 12 intake in Western

countries is primarily based on a 1958

study in which approximately one-half of

the subjects with pernicious anaemia

achieved and maintained maximum

erythropoiesis on long-term follow-up

with intramuscular administration of

vitamin B-12 (median: 1.4 µg/d). A physiologic

average requirement of 1.0 µg vitamin

B-12/d was measured after adjustment

for the extra loss of vitamin B-12 by

subjects with pernicious anaemia. After

adjustment for incomplete absorption of

vitamin B-12 from food (50%), an Estimated

Average Requirement (EAR) of 2.0

µg vitamin B-12/d was established. The

current RDA of 2.4 µg vitamin B-12/d was

derived by multiplying the EAR by 1.2.

Although this approach may have merit,


MEDICAL

the data used to develop the current

RDA came from a small number of

subjects, with the use of hematocrit

and mean corpuscular volume

(MCV) values as the only endpoints,

and did not take into account that

many patients with vitamin B-12 deficiency

only develop neurologic

symptoms.

The RDA of vitamin B-12 for adults in the

United States is 2.4 µg/d. In Western

diets, the dietary intake of vitamin

B12 is usually higher than the current

RDA of 2.4 µg/d.

10% to 30% of adults older than 50 years

often have vitamin B12 malabsorption

syndromes, driving absorption rates as low

as 1% of the ingested B12. Thus, those

adults who meet the RDA of 2.4 µg/d

would need to ingest 240 μg of vitamin

B12 to absorb at least 2.4 μg.

In another study, it was observed that for

healthy adults between the ages of 18 and

50 years, a dietary vitamin B 12 intake of 4

–7 µg/d is associated with normal

vitamin B 12 status as judged from

measurements of cobalamin, holotranscobalamin,

tHcy, and MMA. Thus,

the current RDA of 2.4 µg vitamin B-

12/d may be inadequate for optimal

biomarker status.

Data from the 1999–2000 National Health

and Nutrition Examination Survey

(NHANES) indicate that the median daily

intake of vitamin B12 for the U.S. population

is 3.4 mcg.

Various studies have indicated losses of 0.1

to 0.2 per cent/day of the vitamin B12 pool

regardless of the size of the pool. A loss of

0.2 per cent appears to be typical for individuals

who do not reabsorb biliary vitamin

B12 because of pernicious anaemia. A

person with a vitamin B12 pool of 1,000 μg

and a loss of 0.1 per cent would excrete 1

μg of vitamin B12 daily, and a person with

a 3,000-μg pool would excrete 3 μg daily.

If only 50 per cent of dietary vitamin

B12 is absorbed, the amounts required

daily to replenish the pools

are 2 and 6 μg of B12, respectively.

Information from the Boston Nutritional

Status Survey on supplement use of vitamin

B12 by a free-living elderly population

mentions that for those taking supplements,

the fiftieth percentile of supplemental

vitamin B12 intake was 5.0 μg for

men and 6.0 μg for women.

In Indian Population: India is one of

the countries with the lowest RDA

for vitamins.

When it comes to India, as discussed

above, Indian population lacks vitamin

B12 fortified food items as well

as does not get enough vitamin B12

from their daily diet too. Hence, there

is an increased need for vitamin B12

supplementation with higher RDA in

Indian population.

Vitamin B12 deficiency in India is further

alarming because at the time when

there are suggestions to increase the

RDA of vitamin B12 in Western

countries… back here in India, the

current RDA set by ICMR for vitamin

B12 is only 1.0 µg/d which is far

lesser than the current western RDA

for vitamin B12!!!

Thus, the call of the day is to

revise the RDA levels.

Against the backdrop of the extent of vitamin

B12 deficiency in India, researchers

and manufacturers have urged Food Safety

and Standards Authority of India (FSSAI)

to revise the RDA values.

Tolerable Upper Levels (TUL)

No adverse effects have been associated

with excess vitamin B12 intake from food

or supplements in healthy individuals.

Studies involving periodic parenteral administration

of vitamin B12 (1 to 5 mg) to

patients with pernicious anaemia provide

supportive evidence for the lack of adverse

effects at high doses. As indicated earlier,

when high doses are given orally

only a small percentage of vitamin

B12 can be absorbed from the gastrointestinal

tract, which may


MEDICAL

explain the apparent low toxicity.

Thus setting up a TUL for vitamin

B12 is the need of the hour!

ICMR has submitted a proposal on adopting

TUL on these products to the FSSAI.

Under TUL, the vitamin, mineral content

in a product will be higher than the permitted

RDA values but within tolerable

limits.

Conclusion

On the basis of all the above considerations,

we request the FSSAI and ICMR to

urgently look into the increased cases of

Vitamin B12 deficiency, revision of RDA

as well as TUL of Vitamin B12. Due to the

high burden of vitamin B12 deficiencies

among Indian population, forces must

come together and galvanize to curb this

nutritional epidemic of potentially mammoth

proportions.

~ By Sushmita Chatterjee Kuswa

We await with bated breaths for FSSAI to accept the ICMR proposed TUL for vitamin B12.


PERSONALITIES

SHINDE JAGANNATH SAKHARAM

Chairman – MSCDA LTD , AIOCD LTD & President – The Maharashtra State

Chemist and Drug Association

His areas of interest is to minimize the trade related disputes by setting

and effectively implementing trade practices/ norms for mutual benefit

of trade and pharmaceutical companies. Improving and uplifting

the standards of services rendered to consumers by retailers by conducting

continuous training programs for them encompassing patient

counseling, disease management, behavioral and personality development

and working capital management. He has ambitious plans to

convert existing mom and pop stores into a large organized retail

chain, supported by state of art IT infrastructure and world’s best in

class SOP in handling all types of storage conditions to ensure the full

potency of the product is delivered to end customer and with complete

transparency.

Sh. Shinde inspired all members to form a corporate entity to leverage

their true strength and bringing in huge value to them by entering into

the business of:

*Organized Distribution, ** Organized Retail Chain,

***Market Research Data

SHINDE JAGANNATH SAKHARAM

Chairman – MSCDA LTD , AIOCD LTD & President

– The Maharashtra State Chem & Drug Association.

Shri Shinde Jagannath Sakharam has experience of

over 20 years of relentless working in the field of Indian

Pharmaceuticals Trade for the betterment of more than

850,000 Retailers and Pharmaceutical stock fraternity

of India by understanding and solving their trade

related issues by negotiating and setting the trade practices

between the trade and pharmaceutical manufacturers by

using the forum of All India Organization of Chemists

& Druggists (AIOCD Association).

Professional & Organizational Achievements

He has relentlessly worked for over 20 years at all India level for building

the cohesive force and strong bonding between all the State level

associations and worked for bringing the status and stature of AIOCD

at today's enviable position. He has travelled almost across India for

developing AIOCD's network through its stock and retailer members

at various remote and inaccessible places.

In Maharashtra, he built the organization from grass root level by

creating three tier of association i.e. Taluka Associations, District

Associations and State Level Associations. His major contribution

is he identified, developed and nurtured a pool of vibrant and efficient

leaders at all levels.


PERSONALITIES

His amazing style, persuasion and

network convinced Government of

India to revise VAT on medicine

from 12.5% to 4%.

He convinced Central Government

and most of the State Governments

to keep medicine dealers out of purview

of Value Added Tax (VAT) and

collect VAT on MRP for the initial

period. Our retailers are benefited by

this decision and they are free of all

types of problems.

He has formed the Educational &

Welfare Trust of MSCDA to help the

chemists and their families in the

hour of need. Arranged monitory

help for educational, hospitalization

and to fight the natural or accidental

calamities. However, this help is also

extended to the other needy people

of Maharashtra State

He has inspired all the district associations

to form Chemists Credit and

wholesalers and bring them on line

to keep inventory and expiry, nonmoving

under control. This has already

started to make it happen.

With the help of state pharmacy

council, he developed a syllabus for a

professional pharmacy course for

upgrading knowledge of practicing

owner pharmacists under AIOCD

Ltd. Currently over 6000 participants

have attended various training

programs in Maharashtra.

Under his leadership all the district

level association offices are now connected

via internet and emails. He

has inspired all district associations

to establish their own offices and

build own buildings as Chemists

Bhavan and at some places Dawa

Bazar. In Maharashtra, all the associations

have their offices and 24

district level Chemists Bhavans and

Dawa Bazar at 5 places.

thorities for developing roads and tree

plantation to protect the environment in

Kalyan (E). Conducted health and educational

camps of children for backward

class.

Formed Shivniketan Trust and Military

school on sprawling 30 acres of

land for education at Khadavali in

Kalyan District for students between

5th to 12th standard.

During the heavy rainfall and flood

in July 2005, he rescued people from

flooded area and further supplied

medicines for them in Kalyan and

Dombivli area.

When the swine flu erupted in the

State of Maharashtra, he created

awareness within the society about

swine flu epidemic by distributing

informative leaflets and free face

masks.

In Soygaon Taluka of Aurangabad

District in the State of Maharashtra,

Capital Societies to finance small and

needy chemists and made them selfsufficient

and to promote the spirit of

Co-Operation. In Maharashtra 9

such cooperative societies have been

formed at Ratnagiri, Kolhapur, Satara,

Sangli, Jalgaon, Nandurbar,

Dhule, Nashik, and Yeotmal.

He has inspired to form M/S.Green

Cross Healthcare Pvt. Ltd. to run

retail chain stores under the Company

Act and based on a franchisee

business model. Company is running

26 stores successfully in Mumbai.

He encouraged computerization of

retail medical stores along with the

In his passion for education and training,

he takes huge interest in managing and

developing the project in the field of education

under the Shiv Niketan trust which

is running a residential Military School at

village Khadavali in tribal area of Thane

District of Maharashtra State. Currently

400 resident students upto 12th Standard

are pursuing education. He has plans to

start engineering college in next 2 years

initially with 4 Disciplines and overall, 7

Disciplines.

Exemplary Contribution:

He has followed with Government au-

he distributed complete nutritional

food regularly and successfully

improved the health of under

nourished children.

Social Contribution: -

Advisor Modern School, Kalyan .

President Priyadarshini Youth Club,

Kalyan, Education and Welfare Soc. Talwarbaji

Association Thane, Thane District

Sports Teacher Welfare Association &

Thane Aatya Patya Association .

Advisor Kabbadi Association, Kalyan.

Founder Jaishankar Krida Mandal,

Kalyan .


PERSONALITIES

RAJIV SINGHAL

General Secretary of AIOCD

Rajiv Singhal started his career way back

in 1973 when he completed his schooling

from Gwalior. He struggled very hard for

establishing business. Leadership skill

was there from the beginning.

Currently General Secretary of

AIOCD, a flashback to his past has many

struggles. He became Secretary of his

Mohalla Sudhar Samiti in school days &

represented college in the student’s associations

with other social responsibilities

in other social organizations. Became

General Secretary of Districts Gwalior

Chemists & Druggists association in1989.

Some past associations before taking

All India Organization of Chemists and

Druggists Association was formed in 1975

with the induction of all state organisations

of the country at that time. AIOCD

struggled very hard to get the proper margin

for the Chemists & Druggists of the

country, settlement of Leakage/ Breakages

/ Expiry. AIOCD has mobilized

active plunge in Chemist Association are :

Member Chamber of Commerce MP

Past Secretary Indore Jaycees

Past President Lions Club Indore

Past District Chairman Lions International

Past Vice President MP Agarwal Yuvak

Mahasabha

Member Ahilya Chamber of Commerce

Responsibilities in Chemists Association

* Member Districts Gwalior Chemists and

Druggists Association since 1979

* E C Members Districts Gwalior Chemists

and Druggists Association 1985 to

1989

* General Secretary Districts Gwalior

Chemists and Drug Association 1989 to

1996

* Patron Districts Gwalior Chemists &

Druggists Association since 2005.

* Joint Secretary MP Chemists & Druggists

Association 1995 to 2002

AIOCD

funds and free medicines for Kargil

Jawans, flood affected victims of Orissa,

Kerala, Andhra, Tamilnadu and all other

places of the country at the time of necessity.

AIOCD has also contributed for

Earthquake victims of Kutch. Our members

are running a day & night

“Samarpan Blood Bank” at Ghatkopar,

* Member Indore Chemists Association

since 1995

* Organising Secretary MP Chemists &

Druggists Association 2002 to 2006

* General Secretary MP Chemists & Druggists

Association since 2006.

* Editor Madhya Pradesh Chemists

Sambvad since 2002

* EC member AIOCD since 1995

* Chairman AIOCD Bulletin since 2008

* Member various committees AIOCD

since 1995

* General Secretary AIOCD since 2017.

Efforts :

* Conducted many seminars for GST in

the country.

* Conducted various seminars throughout

country for upgradation of Chemist’s fraternity.

* Wishes to contribute all efforts to upgrade

the knowledge of members.

* Wish to establish M and M Chain

throughout the country for the chemists.

NAVI Mumbai and so many other places

of the country.

AIOCD have successfully convinced

Govt. authorities such as NPPA and voluntarily

sacrificed margins on intravenous

fluids such as Dextrose, Normal

Saline etc.


PERSONALITIES

It has erected much acclaimed Model

Pharmacy at Indian Pharmaceutical Congress

held in Mumbai. Chain Medicine

Plus More is working fantastically well in

Maharashtra and other parts of the country.

AIOCD members have established Pharmacy

college at many places of the country

and are very well and effectively managing

it.

AIOCD members have occupied distinguished

positions. Some are on the panels

of State and All India Pharmacy Councils

also.

AIOCD are arranging Blood Donation

Camps, Medical Camps at District & State

Levels, distributing medicine free of cost

to the needy people. Patient’s counseling

is the main objective of our members so

that the patients are give proper guidance

by our Pharmacists.

AIOCD is the part and partial of Govt to

deliver the medicine throughout the

country with the approved margin by the

Govt of India. AIOCD was instrumental

for achieving less VAT rate on medicine

and Maximum Retail Price printed on

Medicine in the country.

AIOCD served humanity during the entire

lock down and has proved their services

towards needy people, as they are

doing since last so many decades. All the

time AIOCD has helped Govt during

flood and other natural calamities in past

in Kerala, Orrisa, Tamilnadu, Seemandhra,

Launch of AIOCD AWADS


PERSONALITIES

and other states. Also 8.50 lakhs plus

members are serving nation by making

availability of medicine throughout day

and night and in nook and corner of the

country.

AIOCD’s President Mr J S Shinde promised

to PM through Web Meeting that

members will not leave any stone unturned

to deliver the proper medicines to

the country.

During lock down when everything was

locked, AIOCD members served the Indian

population. Govt of India was informed

regarding the shortages of anti-

Diabetic, anti– hypertensive drugs, Insulin,

etc and helped all State Govts in making

availability of the same specially in

North East 7 sisters, Punjab, Himachal, J

& K, Haryana and all remote areas of the

country .

Since it was lockdown everywhere in the

country it was very difficult to dispatch

medicines to other places even in local

areas due to local administration everywhere,

because transport and couriers

were also shut but all state association

and all 730 Districts Association did wonderful

job so that the shortages of medicines

did not occur.

Write up on AIOCD in association

with Creative Solutions and Secretary

Mr Rajiv Singhal

AIOCD has been active in sensitization

to the Government and have sent many

letters to Prime Minister, Health Minister,

Jt. secretary PMO, Niti Ayog, NPPA,

Department of Consumer Affairs, Chief

Ministers of all States and other official to

help in laying down the process for drug

delivery system to fight with the Covid

situation.

All India Organisation of Chemists and

Druggists, the organisation of 8.50 lakhs

+ chemists of the country, are committed

to serve humanity in all crucial situation

and condition. AIOCD is taking all steps

for the survival of their 8.50 lakh members

their 40 lakh family members and 50

lakh staff members and their 2.5 cr family

members approximately 3 crore members,

so that they they are not deprived

from their bread and butter because of

these E-Pharmacies .

AIOCD and its State and District Associations

have filed many court cases

against theses E-Pharmacies and got the

court order to stop illegal business of E-

Pharmacies in the country. At the start of

Covid pandemic, E-Pharmacies influenced

Govt by advertising E-Pharmacies

on Aarogya Setu App. AIOCD fought for

its members, forcing the Govt of India to

remove advertisement of E-Pharmacies

from the Aarogya Setu App.

AIOCD is always conducting many educational

seminars and refresher courses

for its members so that the members upgrade

their knowledge.

AIOCD always insist their members to be

careful and alert while handling cold

chain products for which hundreds of

seminars have been taken by AIOCD and

their state associations. Motto is to deliver

medicine to the poor human at the

fixed prizes by the Govt and in same conditions

for which the medicine is to be

kept.

AIOCD is taking utmost care to give

proper guidance to the members so that

they can serve the country with all the

modern ideas and with computerisation .

We hope that Govt of India will fully understand

the voice of Chemists of Country

and will promote “VOCAL for LOCAL

“, so that survival of 8.59 lakh members &

their families are not in danger.

CREATIVE SOLUTIONS

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Health Care

For Creative designing & Printing,

Clinical Trial, BA/BE Studies, Brand

searching, Brand registration Bar

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P2P Business, Launching new

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Product/ Soft skill On line reporting &

Website development (Connect for

Collaboration /Solutions at dmbanerjee@yahoo.co.in


HEALTH AND WELLNESS

Management of co-infection of COVID-19 with

other seasonal epidemic prone diseases

Almost all States/UTs of the country are

affected by COVID-19. Given the seasonal

pattern of epidemic prone diseases observed

every year in our country, diseases

like Dengue, Malaria, Seasonal Influenza,

Leptospirosis, Chikungunya, Enteric fever,

etc. can not only present as a diagnostic

dilemma but may co-exist in

COVID cases. This poses challenges in

clinical and laboratory diagnosis of

COVID , and have a bearing on clinical

management and patient outcomes. Ministry

of Health and family Welfare have

specified certain guidelines for management

of co-infection of COVID-19 with

other seasonal epidemic prone diseases .

As per the World Health Organization

(WHO) definition, a COVID case may

present with:

Acute onset of fever AND cough; OR

Acute onset of ANY THREE OR

MORE of the following signs or

symptoms: fever, cough, general

weakness/fatigue, headache, myalgia,

The following table shows salient features of certain common infections

Onset

Symptoms

sore throat, coryza, dyspnoea, anorexia/nausea/

vomiting, diarrhoea,

altered mental status.

This case definition, although sensitive, is

not very specific. Seasonal epidemic

prone diseases, as cited in the foregoing

paragraphs may all present as febrile illness,

with symptoms that mimic COVID-

19. If there is a co-infection, then apart

from the febrile illness there may be constellation

of signs and symptoms that may

lead to difficulty in diagnosis. A comparative

analysis of disease onset, symptoms,

signs, warning signs, complications and

diagnosis is given in below table.

COVID 19 Dengue Malaria Chikungunya Leptospirosis Seasonal

Influenza

IP: 2-14 days.

(onset of symptom

average 5-7

days). Acute

onset of low to

moderate grade

continuous fever

Cough

Dyspnoea

Fever

Myalgia

Headache

Sore throat

Diarrhoea

Abdominal pain

Rhinorrhoea

IP: ranges from 3

- 14 days (onset

of symptom average

4-7 days).

Acute onset of

high-grade continuous

fever

Fever,

Headache,

Nausea

Vomiting

Retro-orbital

pain, Myalgia

Arthralgia

Rash

Bleeding

P. falciparum

(IP: 9-14 days)

P.vivax (IP 10-

14 days). Acute

onset of highgrade

intermittent

fever

Fever, Chills,

Malaise, Fatigue,

Diaphoresis

(sweating),

Headache,

Cough, Anorexia,

Nausea,

Vomiting, Abdominal

pain,

Diarrhea,

Arthralgias,

Myalgias

IP: 1-12 days

(Onset of symptom

average 3-7

days). Acute

onset of moderate

to high grade

continuous fever

Fever

Rash

Malaise

Arthralgia

Myalgia

Red Eyes

IP: 2-26 days

(onset of symptom

Average- 6-10

days) . Acute onset

of moderate to

high grade continuous

fever

Fever,

Rigors,

Myalgia,

Headache,

Conjunctival suffusion,

Nausea,

Vomiting

Diarrhoea

IP: 1-4 days

(onset of symptom

average - 2

days). Acute

onset of moderate

to high

grade continuous

fever

Fever, Cough,

Sore throat, and

Nasal discharge,

Headache,

Myalgia,

Malaise,


HEALTH AND WELLNESS

Signs

Warning signs

Complications

COVID 19 Dengue Malaria Chikungunya Leptospirosis Seasonal

Influenza

Tachypnea, Decreased

oxygen

saturation, Multi

organ involvement

Respiratory distress

≤SpO2

ARDS

Arrythmias

Acute cardiac

injury

Shock pulmonary

embolism

Shock acute

stroke

Signs of Hy-

Potension and

shock, hemorrhagic

manifestations

(petechiae),

Positive tourniquet

test

Persistent vomiting,

Abdominal

tenderness, Fluid

accumulation,

Mucosal bleed

Hypotensive

Shock,

bleeding,

Organ involvement,

Metabolic derangement.

Pallor, Palpable

spleen

Persistent high

grade intermittent

fever, vomiting,

lethargy,

low urine output

Altered Sensorium,

Acidosis hypoglycemia,

ARDS, Renal

Impairment,

Liver Dysfunction

Swelling and

tenderness of

joints,

High grade fever,

progressive increase

of myalgia

and arthralgia.

Respiratory failure,

Cardiovascular

decompensation,

Myocarditis,

Acute

hepatitis, Renal

failure, Hemorrhage,

Meningoencephalitis,

Acute Flaccid

Paralysis GBS

Subconjunctival

Haemorrhages,

Red eyes, Muscle

tenderness,

Splenomegaly,

Hepatomegaly,

Muscle rigidity

Skin rash

High grade fever,

LFT derangement,

Aseptic Meningitis,

Jaundice and

Renal failure

(Weil’s Disease)

Pulmonary hemorrhage,

Acute

Respiratory Distress

Syndrome

(ARDS), Uveitis,

Optic neuritis,

Peripheral neuropathy,

Myocarditis,

and Rhabdomyolysis

Pharyngeal wall

hyperemia,

Cervical lymphadenopathy

Respiratory distress

≤SpO2

ARDS, Myositis,

Rhabdomyolisis,

Acute MI Myocarditis,

Pericarditis,

Encephalitis

Myelitis, GBS

Approach to diagnosis of

suspected co-infection

A high index of suspicion must be maintained

for epidemic prone diseases (e.g.

Dengue, Malaria, Chikungunya, Seasonal

influenza, Leptospirosis) prevalent in a

particular geographic region during monsoon

and post-monsoon seasons. Bacterial

co-infections must also be suspected

in moderate or severe cases of COVID-19

not responding to treatment.

Malaria/Dengue: It must be borne in

mind that malaria/dengue can coexist

with other infections, and thus confirmation

of malaria/dengue infection does not

rule out the possibility of the patient not

suffering from COVID-19. Similarly, a

high index of suspicion of malaria/

dengue must be there when a fever case is

diagnosed as COVID-19, particularly during

the rainy and post rainy season in

areas endemic for these diseases.

Seasonal Influenza: Both COVID-19

and Seasonal Influenza present as Influenza

Like Illness (ILI)/SARI, hence all

ILI/SARI cases in areas reporting COVID

-19 cases must be evaluated and tested for

both COVID-19 and Seasonal Influenza, if

both viruses are circulating in population

under consideration.


HEALTH AND WELLNESS

Chikungunya: Chikungunya presents

with acute onset of moderate to high

grade continuous fever and malaise followed

by rash, myalgia and arthralgia.

Respiratory failure may ensue in late

stages. Co-infection with COVID-19 may

be suspected in Chikungunya endemic

areas, in the months of monsoon.

Leptospirosis: Leptospirosis apart from

it presenting as febrile illness, has also

the tendency to manifest as acute respiratory

illness, leading to respiratory distress

and shock. In areas where Leptospirosis

is known to cause outbreaks during monsoon/

post monsoon, the possibility of

coinfection should be considered.

Scrub Typhus: Scrub typhus is known

to be prevalent in foothills of Himalayas

viz Jammu & Kashmir, Himachal

Pradesh, Sikkim, Manipur, Nagaland,

Meghalaya, etc. However, in recent past,

scrub typhus outbreaks have also been

reported from Delhi, Haryana, Rajasthan,

Maharashtra, Uttarakhand, Chhattisgarh,

Tamil Nadu and Kerala. The clinical picture

consists of sudden high-grade fever,

severe headache, apathy, myalgia and

generalized lymphadenopathy. A maculopapular

rash may appear first on the

trunk and then on the extremities and

blanches within a few days. The patients

may develop complications that include

interstitial pneumonia (30 to 65% of

Laboratory Testing: Co-infection of COVID 19 with other seasonal epidemic prone diseases

cases), meningoencephalitis and myocarditis.

Scrub typhus infection may co-exist

with COVID-19.

Bacterial infections: Few patients with

COVID-19 experience a secondary bacterial

infection. In such cases, empiric antibiotic

therapy as per local antibiogram

needs to be considered.

Despite the possibility of above mentioned

co-infections, in present times of

the pandemic, approach to diagnosis for

COVID-19 essentially remains the same.

Testing protocol as per MoHFW/ICMR

guidelines will be followed. However, in

addition, further tests for a likely coinfection

will also be undertaken, whenever

suspected.

Diseases Tests Sample

Dengue

Chikungunya

NS1 antigen ELISA or RT PCR: For < 5 days of illness

IgM capture ELISA (MAC-ELISA): For >5 days

of illness

Early disease: RT PCR After first week of illness:

IgM capture ELISA

Blood/Serum

Blood/Serum

H1N1 Acute phase: RT PCR Naso/Oropharyngeal swab

COVID 19 Acute phase: RT PCR Nasopharyngeal/ Oropharyngeal

swab

Malaria

Leptospirosis

Scrub Typhus

RDT (bi-valent both Pf/Pv detection)

Quality microscopy for slide positivity confirmation

In endemic areas: IgM ELISA and MAT tests Nonendemic

areas: IgM ELISA followed by MAT test for

confirmation

Detection of IgM antibodies by Weil-Felix Test

(WFT) Enzyme linked Immunosorbent assay (ELISA)

Blood

Blood

-

Serum

Serum

Bacterial co-infections Gram stain and culture, Blood culture Sputum/Bronchial aspirate/Blood


MARKETING

Learn to Change,

Change to Succeed

Successful are those who bring change in

the world, since 'Change' is the only constant

in this world. In this world of continuous

motion, everything is changing,

day changes to night (and vice versa),

child changes to an adult and an adult to

an elderly person and so on. Nothing

remains same over time, everything

changes. When change is inevitable, then

why is it that we resist change? When we

are physically changing continuously,

then why are we not changing mentally

and moving ahead with time, or moving

ahead of time?

Well, the answer lies in our mind. Since

our childhood, we are conditioned to

think positive and believe in ourselves,

repeat the activities that bring us success.

This conditioning of our subconscious

mind is so deeply embedded that we forget

a simple fact that 'what brought us

here, will not lead us there', to move

ahead we need to do something different

and to do something different we need to

change. The activities that brought us

success then will not bring us success

today, as everything has changed, and

now we have to change our actions to be

successful. To change our actions, we

need to change ourselves, our thought

process.

All the interpretation of our success till

now is assigned to:

1. Our past performance: If all that

I did, lead me to this success then I don't

need to change, what I am doing is right.

Individuals and organizations have failed

believing this. There are numerous examples

like Kodak, Nokia, Swiss watches,

etc, which believed that their future success

is secured based on their past success,

and resisted change. It is quite evident,

now they are either struggling or

existing nowhere. On the other hand,

there are individuals and organizations

that succeeded by changing before or

with time, like Tata group, Reliance,

Google, etc. and Amitabh Bacchan, as an

individual who got himself into the ventures

those were not accepted/explored

by other individuals of his age or stature.

Ability to influence success: All successful

people believe in their own ability and

are opposed to the idea of being lucky. Since

their ability to succeed has brought them

here, they are able to influence success in

future too. Abilities, too require to change

continuously, as technology and times are

changing, we need a continuous upgradation

of our abilities too.

Gurdeep Singh

Bachelor of Pharmacy (Gold. Medallist)

Mr Gurdeep Singh has started his profession

in Pharmaceutical sales from

Cadila and worked for Ranbaxy, Glaxo

and Allergan at various positions. Handled

training for over 10 years, where he

has trained hundreds of professionals in

sales and marketing. Also worked as a

Product Manager at Win Medicare,

Delhi. Started his own pharmaceutical

company by the name Astron

Lifesciences Pvt. Ltd. in 2005 and Marketing

& Promotion Consultancy company

by the name Ziva Resources LLP

in 2016. With the passion of sharing

knowledge that he gained during his

education and professional years, He

was also involved in delivering seminars

and conducting workshops for professional

college students and pharma professionals.

He has written on various

topics like Personal Development, Interpersonal

skills, Communication skills,

Success principles and related topics.


MARKETING

Like, every organization is now tech

driven and every individual is required to

have an ability to use technology, failing

which will fail them too.

Optimistic belief: Our optimistic belief

that has given us success in the past can

be a disguise, since we believe that we will

continue to be successful in the future

too. Optimism that brought us success

makes us resist change. Being optimistic

is nice but we need to embrace change

with optimism and start thinking out of

our comfort zones, and that too on a continuous

basis.

Sense of control: We have over-stated

our sense of control over our destiny (as

opposed to being controlled by the external

forces). Therefore, the external stimuli

to change us is resisted by us. It is always

better to sense the change and

change ourselves before the change forces

us to change. It is OK to believe that not

everything is under our control, actually

we can only control our actions and not

the results/outcome. Results should be

used as a feedback to improve our actions

and this is what change is all about.

The mix of all the above beliefs makes it a

blessing, as well as disguise for us to

change. It takes a wise person (or a

proper coaching) to analyse their success

in an objective manner so that whenever

required, we must be constantly open to

'CHANGE'.

To summarize, follow these steps to be a

progressively successful individual/

organization:

Make small changes continuously -

Analyse your current skills that are making

you successful and look ahead at future

(5, 10 or may be 25 years), whether

the same skills are sufficient or you need

to add/improve it with time? And in most

of the cases the answer will be ‘YES’, improvement/change

is required. This is the

right time then, to make small changes on

a continuous basis so that it does not become

a mountain of changes over time,

which will become impossible for you or

your organization to embrace.

Upgrade yourself technologically

This is a technology driven world,


MARKETING

everything is changing faster than ever, in

the human history. Be aware of the technology

that is influencing your field of

work and start upgrading yourself (one

step at a time, no matter how small it is).

Learn daily – Since we never stop growing,

we should also never stop learning.

At the end of the day if you cannot see a

better ‘you’ from yesterday, then you are

moving away from your future success.

Make it a point of adding at least one skill

(no matter how small it is), one improvement

or one positive change in yourself or

your organization everyday to stay in the

game of success.

Be flexible, always – Flexibility is the

virtue of life and stiffness, of death. Be

open to all the ideas that come to you and

be prepared to implement any one of

them if you find them useful. Most of the

times we live in a cocoon of our own ideas

and resist new ones coming to us. Ideas

may come to you from different and unusual

sources, so be perceptive and open

minded, always.

To be highly successful

“Change before

the ‘Change’

forces you to

Change!”

~By Gurdeep Singh



Patent Opposition in India

A patent is an exclusive monopoly

granted to the inventor, for an

‘invention- product or process’ to

lawfully exclude others from making,

selling or using the invention. The

processing of a patent application is a

multi-stage process that involves-

Filing of an application

Electronic data processing

Screening and classification

Publication

Examination

Hearing, if required

Pre-grant opposition

Grant/refusal

post-grant opposition

The procedure for filing patent application

and its processing up to grant/

refusal, maintenance etc. are governed by

The Patents Act, 1970. This article

focuses on the opposition system in Indian

Patenting procedures. Opposition

proceedings, in fact, in any jurisdiction

are fundamentally required to confine the

grant of wrongful or frivolous inventions

by third parties before or after the grant

of a patent. Every jurisdiction follows

certain laws to impede such illegitimate

grant of patent. The Indian Patent Act

provides the provision of both pre-grant

as well as post-grant opposition. Section

25 of the Act as amended in 2005, governs

the provisions for opposition proceedings

to grant of patents.

Pre grant opposition

The provisions of section 25(1) of the Indian

patent (Amendment) Act 2005 governs

the filing of a pre grant opposition by

third parties against a patent application,

based on the grounds provided under this

section. Under this provision any person

or third party may, in writing, represent

by way of opposition to the Controller

against the grant of pending patent application

after it has been published. The

Indian jurisdiction provides third parties

a time period of 6 months from the date

of publication of the application to the

grant of a patent, to file the representation

for opposition in Form-7(A) along

with a statement and evidence in support

of the opposition. However, the Opponent

may file the representation only after the

request for examination of the application

has already been filed by the Applicant.

The Controller then notifies the Applicant,

based on the virtue of representation

by the Opponent, and the Applicant

is required to submit a reply statement

within three months of receipt of the notice

along with evidence, if any. The Controller

then after considering the written

submissions and hearing both parties,

may either dispose-off the opposition and

proceed with the grant of patent, or ask

the applicant for certain amendments in

the complete specification and/or other

documents before allowing for the grant

of patent, or may refuse the grant of patent

by passing an order under Section 15

of the Patent Act, 1970.

Tanu Singh

Tanu Singh is a founder and Director

of Intellect Vidhya Solutions LLP.

She has 9 years of IPR industry

experience. She is a Registered

Indian Patent agent. She has

co-authored a book named "All you

want to know about patent" and has a

publication in her name in Pharmabiz.



Post grant opposition

The provisions of section 25(2) of the

Indian Patent (Amendment) Act 2005

governs the filing of a post grant opposition

by any ‘person interested’ after the

grant of the patent but before the expiry

of a period of one year from the date of

publication of grant of the patent, by way

of notice of opposition made in form 7

and sent to the controller in duplicate.

The Opposition may be made on any of

the grounds disclosed in section 25(2).

The "person interested" as per section 2

(1)(t) is defined as including a person

engaged in, or in promoting, research in

the same field as that to which the invention

relates.

On receiving the notice of opposition, the

controller constitutes an opposition

board, comprising three members, where

one of them is a chairman. The opposition

board conducts the examination of

the notice of opposition and the documents

filed under rules 57 to 60 and submit

its recommendations to the controller

within three months. Further a hearing is

scheduled between both parties by the

controller and decision for the patent to

be revoked, maintained

or amended is

taken.

It is to be noted that

the pre-grant opposition

under section 25

(1) is wider than the

post-grant opposition

under section 25(2),

as the latter allows

only ‘person interested’

to file the representation.

The

grounds of opposition for both the pre

grant and post grant oppositions are

similar.

Both Pre grant and Post grant opposition

can be made on the grounds listed below:

Wrongfully obtaining the invention

Anticipation by prior publication

Anticipation by prior date, prior

claiming in India

Prior public knowledge or public use

in India

Obviousness and lack of inventive

step

Non patentable subject matter

Insufficiency of description of the

invention

Non-disclosure of information as per

the requirement or providing materially

false information by an applicant

Patent application not filed within 12

months of filing the first application

in a convention country

Nondisclosure/ wrong mention of

source of biological material. Invention

anticipated with regard to traditional

knowledge of any community,

anywhere in the world.



Difference between pre grant and post grant opposition

Parameters Pre-Grant Opposition Post Grant Opposition

Filed By Any Person Person Interested

Form Form 7A Form 7

Time period for filing

Any time after the request has

been made but before the grant of

the patent.

Within 1 Year after the grant of

the patent.

Fee No fee Fee prescribed in the Patent Act

1970

Infringement Proceedings No infringement proceedings

Coat and time consumption

More economic, effective and

faster disposal of cases

Infringement proceedings are considered

High cost incurred, and time consuming

proceedings due to trials

and extended hearing in court.

Some remarkable judgements in

opposition proceedings

Novartis Ag vs Natco Pharma Ltd.

on 25 January, 2006:

In this case, the patent application of

Novartis Ag, 1602/MAS/1998 was

refused under section 15 during the opposition

proceedings. The invention titled

"Crystal Modification of A.N.-

Phenyt-2-Pyrimidineamine derivative,

processes for its manufacture

and its use was challenged by a way of

representation under section 25(1) by

Natco pharma on the grounds that

imatinib mesylate is known from the US

Patent No: 5521184 and was also cited in

another prior publication. Further, non

patentability under 3(d) was also raised

as one of the grounds, as the applicant

has claimed a polymorphic form of already

known imatininb mesylate. The

opponent established that the affidavits

submitted by the applicant do not prove

any significant enhancement in the efficacy,

and also proved the grounds based

on prior publications & wrongful priority

claim. The application was, thus, rejected

by the Controller.

American biosciences INC vs Natco

pharma:

The application titled “Sterile Pharmaceutical

Composition” was challenged by

a way of opposition as per section 25(1)

under the grounds of section 2(1)(j), 3(e)

and 10. After examining all the documents

submitted by both the parties and

the arguments made by them during the

hearing, the claims were found non patentable

u/s 2(1)(j), 3(e ) and 10 of the

Patents Act, 1970, and therefore, the instant

application was refused u/s 15 for

grant of patent. The Applicant filed an

appeal in ‘Intellectual Property Appellate

Board’ (IPAB) against the said decision,

where the Hon’ble IPAB reconsidered the

case and set aside the order of the Controller,

further remanding the matter to

the Assistant Controller for fresh consideration.

The opponent filed a fresh representation

u/s 25(1) on 28/03/2014 under the

grounds of section 25(1)(g) and 25(1)(f)

limited to section 3(d). After considering

all the submissions, the Controller concluded

that amended claims 1 to 12 lack

inventive step and do not constitute an

invention u/s 2(1)(j) of the Patents act,

1970. It was also presented that the pending

claims fall u/s 3(d) and 3(e) of the

Patents Act, 1970. The application was

finally refused for grant of patent.



Recent Trends in Pre-grant opposition

The Indian Patenting system allows any

person (third party) to file a pre-grant

opposition and that too free of cost. The

idea behind this provision is to aid the

examination procedure of an invention,

and to encumber granting of wrongful or

frivolous inventions, as was held by the

Hon’ble Delhi High Court in UCB Farchim

vs. Cipla Ltd. & Ors.

“….This Court finds merit in the contention

that the pre-grant opposition is in

fact “in aid of the examination” of

the patent application by the Controller….”

However, quite frequently nowadays, it is

observed, that the third party tries to misuse

their rights in delaying the grant of

several important patents using illegitimate

strategies. In several patent applications

made at Indian Patent Office, a multiple

number of pre-grant oppositions are

filed by the Opponents one after another

without providing useful insights into the

matter by citing any new references or

necessary evidence over the already considered

responses to examination report

or already file representation of oppositions.

This line of attack is merely to delay

the grant of a patent.

Apparently, such strategies do not comply

with the judicial intent of assisting the

examination of the application and is an

exploitation of the legal system of patenting

procedures.

Conclusion

The Opposition system prevalent in our

country may be “a boon or a bane” in the

patenting procedure of a new invention.

To make it a “boon”, some changes in our

legal system are definitely required. The

Controller needs to efficiently identify the

merits in the opposition being filed before

notifying the Applicant about the same. If

the subsequent representation of oppositions

by other opponents carries no further

merits than what has already been

held in the examination reports or former

oppositions, the representation should be

dismissed in-limine. Further, some penalty

must be imposed on such fraudulent

opponents to ensure a legitimate proceeding

of any application as governed by the

Patents Act, with the opposition truly

serving as an ‘aid’ in the examination

procedure towards the grant/refusal of a

patent.

~By Tanu Singh

Leading Patent Provider of Pharmaceutical products

Only one call away

The world leading pharmaceutical

patents provider

www.drsanjayagrawal.com/

9825381729

25 Years of experience in Drugs

innovation and pharmaceutical

product creation


CORONAVIRUS SPECIAL

CORONA VACCINE RACE

S.No CANDIDATE Mechanism SPONSER

TRIAL

PHASE

1 mRNA-1273 mRNA-based vaccine Moderna Phase 3

2 AZD1222

Replication-deficient viral

vector vaccine (adenovirus

from chimpanzees)

The University of Oxford;

AstraZeneca; IQVIA;

Serum Institute of India

Phase 3

3 BNT162 mRNA-based vaccine Pfizer, BioNTech Phase 3

4 Ad5-nCoV

5 CoronaVac

Recombinant vaccine

(adenovirus type 5 vector)

Inactivated vaccine

(formalin with alum adjuvant)

6 Covaxin Inactivated vaccine

7

JNJ-78436735 (formerly

Ad26.COV2.S)

8 No name announced Inactivated vaccine

CanSino Biologics Phase 3

Sinovac Phase 3

Bharat Biotech; National

Institute of Virology

Phase 3

INSTITUTION

Kaiser Permanente Washington

Health Research

Institute

The University of Oxford,

the Jenner Institute

Multiple study sites in

Europe and North America

Tongji Hospital; Wuhan,

China

Sinovac Research and Development

Co., Ltd.

Non-replicating viral vector Johnson & Johnson Phase 3 Johnson & Johnson

Wuhan Institute of Biological

Products; China National

Pharmaceutical

Group (Sinopharm)

Phase 3

Henan Provincial Center for

Disease Control and Prevention

9 NVX-CoV2373 Nanoparticle vaccine Novavax Phase 3 Novavax

10 Sputnik V Non-replicating viral vector

11

Bacillus Calmette-Guerin

(BCG) vaccine

Live-attenuated vaccine

Gamaleya Research Institute,

Acellena Contract Drug

Research and Development

University of Melbourne

and Murdoch Children’s

Research Institute;

Radboud University

Medical Center; Faustman

Lab at Massachusetts General

Hospital

Phase 3

Phase 2/3

12 INO-4800 DNA vaccine (plasmid) Inovio Pharmaceuticals Phase 2/3

13 VIR-7831

Plant-based adjuvant vaccine

14 No name announced Recombinant vaccine

Various

University of Melbourne

and Murdoch Children’s

Research Institute;

Radboud University

Medical Center; Faustman

Lab at Massachusetts General

Hospital

Center for Pharmaceutical

Research, Kansas City.

Mo.; University of Pennsylvania,

Philadelphia

Medicago; GSK; Dynavax Phase 2/3 Medicago

Anhui Zhifei Longcom Biopharmaceutical,

Institute of

Microbiology of the Chinese

Academy of Sciences

Phase 2

Various

15 ZyCoV-D DNA vaccine (plasmid) Zydus Cadila Phase 2 Zydus Cadila

16 No name announced

Adjuvanted protein subunit

vaccine

Phase 1/2

17 AG0301-COVID19 DNA vaccine AnGes, Inc. Phase 1/2

18 BBIBP-CorV Inactivated vaccine

Beijing Institute of Biological

Products; China National

Pharmaceutical

Group (Sinopharm)

Phase 1/2

AnGes, Inc.; Japan Agency

for Medical Research and

Development

Henan Provincial Center for

Disease Control and Prevention


CORONAVIRUS SPECIAL


19 EpiVacCorona Peptide vaccine

Federal Budgetary Research

Institution State Research

Center of Virology and Biotechnology

TRIAL

PHASE

Phase 1/2

20 GX-19 DNA vaccine Genexine Phase 1/2

21 LNP-nCoVsaRNA

22 ARCT-021 (LUNAR-COV19)

Self-amplifying RNA vaccine

Self-replicating RNA vaccine

INSTITUTION

Federal Budgetary Research

Institution State Research

Center of Virology and Biotechnology

Imperial College London Phase 1/2 Imperial College London

Arcturus Therapeutics

and Duke-NUS Medical

School

Phase 1/2

Duke-NUS Medical School,

Singapore

23 No name announced Protein subunit vaccine Sanofi; GlaxoSmithKline Phase 1/2 Various


Chinese Academy of Medical

Sciences, Institute of

Medical Biology

Phase 1/2

West China Second University

Hospital, Yunnan Center

for Disease Control and

Prevention

25 AdimrSC-2f Protein subunit vaccine Adimmune Phase 1 Adimmune

26 bacTRL-Spike

27 COVAX-19

Monovalent oral vaccine

(bifidobacteria)

Monovalent recombinant

protein vaccine

Symvivo Phase 1 Symvivo Corporation

Vaxine Pty Ltd. Phase 1 Royal Adelaide Hospital

28 CVnCoV mRNA-based vaccine CureVac Phase 1 CureVac

29

DelNS1-2019-nCoV-RBD-

OPT1

Replicating viral vector

30 GRAd-COV2 Adenovirus-based vaccine

31 UQ-CSL V451 Protein subunit vaccine

Xiamen University, Beijing

Wantai Biological Pharmacy

Rei-

Thera; Leukocare; Univercel

ls

CSL; The University of

Queensland

Phase 1

Phase 1

Phase 1

32 No name announced Adenovirus-based vaccine ImmunityBio; NantKwest Phase 1

33 SCB-2019 Protein subunit vaccine

34 UB-612

35 V590

Multitope peptide-based

vaccine

Recombinant vaccine

(vesicular stomatitis virus)

36 V591 Measles vector vaccine

37 VXA-CoV2-1

Recombinant vaccine

(adenovirus type 5 vector)

38 AAVCOVID Gene-based vaccine

GlaxoSmith-

Kline, Sanofi, Clover Biopharmaceuticals,

Dynavax a

nd Xiamen Innovax; CEPI

Phase 1

COVAXX Phase 1

Merck; IAVI Phase 1

University of Pittsburgh’s

Center for Vaccine Research

Phase 1

Jiangsu Provincial Centre

For Disease Control and

Prevention

Lazzaro Spallanzani National

Institute for Infectious

Diseases

Linear Clinical Research

(Australia)

United Biomedical Inc.

(UBI)

University of Pittsburgh;

Themis Biosciences;

Institut Pasteur

Vaxart Phase 1 Vaxart

Massachusetts Eye and Ear;

Massachusetts General Hospital;

University of Pennsylvania

Pre-clinical

39 AdCOVID Intranasal vaccine Altimmune Pre-clinical

40 ChAd-SARS-CoV-2-S Adenovirus-based vaccine

Washington University

School of Medicine in St.

Louis

Pre-clinical

University of Alabama at

Birmingham

Washington University

School of Medicine in St.

Louis


CORONAVIRUS SPECIAL


TRIAL

PHASE

41 HaloVax Self-assembling vaccine

Voltron Therapeutics, Inc.;

Hoth Therapeutics, Inc.

Pre-clinical

University of Washington;

42 HDT-301 RNA vaccine

National Institutes of

Health Rocky Mountain

Pre-clinical

Laboratories; HDT Bio Corp

INSTITUTION

MGH Vaccine and Immunotherapy

Center

43 LineaDNA DNA vaccine Takis Biotech Pre-clinical Takis Biotech

44 MRT5500 Recombinant vaccine Sanofi, Translate Bio Pre-clinical

45 No name announced

Ii-Key peptide COVID-19

vaccine

46 No name announced Protein subunit vaccine

47 No name announced mRNA-based vaccine

Generex Biotechnology Pre-clinical Generex

University of Saskatchewan

Vaccine and Infectious Disease

Organization-

International Vaccine Centre

Chulalongkorn University’s

Center of Excellence in Vaccine

Research and Development

Pre-clinical

Pre-clinical

48 No name announced gp96-based vaccine Heat Biologics Pre-clinical


50 PittCoVacc

Recombinant protein subunit

vaccine (delivered

through microneedle array)

Shenzhen Kangtai Biological

Products

UPMC/University of Pittsburgh

School of Medicine

Pre-clinical

Pre-clinical

51 T-COVIDTM Intranasal vaccine Altimmune Pre-clinical

University of Saskatchewan

Vaccine and Infectious Disease

Organization-

International Vaccine Centre

University of Miami Miller

School of Medicine

University of Pittsburgh


OXFORD TECHNOLOGY

CORONAVIRUS SPECIAL

The Oxford COVID-19 vaccine team is led

by Prof Sarah Gilbert, Prof Andrew Pollard,

Prof Teresa Lambe, Dr Sandy Douglas,

Prof Catherine Green and Prof Adrian

Hill. Their team includes scientists from

both the Jenner Institute and the Oxford

Vaccine Group, who bring together decades

of internationally recognised experience

in vaccine research, including responding

to the Ebola outbreak of 2014.

The teams had already used ChAdOx1

vaccine technology to produce candidate

vaccines against a number of pathogens

including flu, Zika and Middle East Respiratory

Syndrome (MERS), another

coronavirus. They had already begun

work on pandemic preparedness with the

technology behind ChAdOx, in preparation

for 'Disease X'. When the disease

emerged in China, they moved quickly. As

soon as the genetic sequence was available,

they began work on a trial.

How the Oxford COVID-19 vaccine

works

The ChAdOx1 vaccine is a chimpanzee

adenovirus vaccine vector. This is a harmless,

weakened adenovirus that usually

causes the common cold in chimpanzees.

ChAdOx1 was chosen as the most suitable

vaccine technology for a SARS-CoV-2

vaccine as it has been shown to generate a

strong immune response from one dose

in other vaccines. It has been genetically

changed so that it is impossible for it to

grow in humans. This also makes it safer

to give to children, the elderly and anyone

with a pre-existing condition such as diabetes.

Chimpanzee adenoviral vectors are

a very well-studied vaccine type, having

been used safely in thousands of subjects.

Coronaviruses have club-shaped

spikes on their outer coats, which

form a corona – Latin for crown –

on the virus surface. Immune responses

from other coronavirus

studies suggest that these spikes are

a good target for a vaccine.

The Oxford vaccine contains the genetic

sequence of this surface spike protein.

When the vaccine enters cells inside the

body, it uses this genetic code to produce

the surface spike protein of the coronavirus.

This induces an immune response,

priming the immune system to attack the

coronavirus if it later infects the body.

The Oxford COVID-19 vaccine trials

The main focus of the Phase I, II and III

studies is to assess whether the ChAdOx1

vaccine is going to work against COVID-

19, that it doesn’t cause unacceptable side

effects and if it induces good immune

responses.

Adult participants will be randomised

to receive one or two doses of

either the ChAdOx1 nCoV-19 vaccine

or a licensed vaccine

(MenACWY) that will be used as a

‘control’ for comparison.

Phase I: The phase I trial in healthy

adult volunteers began in April 2020.

More than 1,000 immunisations were

given in the UK.

Phase II: The phase II part of the

study expands the age range of people

the vaccine is assessed in, to include a

small number of older adults and children.

Researchers will be assessing

the immune response to the vaccine

in people of different ages, to find out

if there is variation in how well the

immune system responds in older

people or children. The group of children

will be recruited later in the trial,

once extensive safety data is available

from the adult studies.

Phase III: The phase III part of the

study involves assessing how the vaccine

works in a large number of people

over the age of 18. This group will

assess how well the vaccine works to

prevent people from becoming infected

and unwell with COVID-19. It

involves multiple locations, including

other countries.

Vaccine results and production

To assess whether the vaccine works to

protect from COVID-19, the statisticians

in our team will compare the number of

infections in the control group with the

number of infections in the vaccinated

group.


CORONAVIRUS SPECIAL

How quickly we reach the numbers required

will depend on the levels of virus

transmission in the community. If transmission

remains high, we may get

enough data in a couple of months to see

if the vaccine works, but if transmission

levels drop, this could take longer. Recruitment

of those who have a higher

chance of being exposed to the virus is

being prioritised, such as frontline

healthcare workers, frontline support

staff and public-facing key workers, in

an effort to capture the efficacy data as

quickly as possible.

An agreement between Oxford University

and AstraZeneca means we are prepared

to produce and scale up distribution

of the vaccine if it is successful. We

will be working closely with our partners

and the British government to ensure

the vaccine is made available as quickly

and fairly as possible and in sufficient

quantities to vaccinate the entire UK

population. As part of our agreement

with AstraZeneca we are ensuring that

those countries who are most vulnerable

to the worst effects of this global pandemic

have early access to a vaccine.

This is just one of hundreds of vaccine

development projects around the world;

ideally several will be successful for the

best possible results for humanity. Lessons

learned from our work on this project

are being shared with teams around

the world to ensure the best chances of

success.

Two Vaccines by February in India

VACCINES UPDATE

Two vaccines could be available by February if all goes

well.

Limited stocks of Oxford –AstraZeneca vaccine likely to be

available by late Jan or Feb. Which will be given to approx

70 lakhs healthcare warriors and 2 crore frontline warriors

which include workers like Doctor, nurses, para military

and municipal staffs.

Government may get the two shot vaccine for half the

COVAXIN -The Covaxin phase 3 trials have commenced in

several states in the country, including Haryana, West

Bengal, Madhya Pradesh and other states are also expected

to begin soon. The trials of its Covid-19 vaccine candidate

-- Covaxin manufactured by Bharat Biotech-- which

involves 26,000 participants across 22 sites in the country,

began on 16 November. It is the largest clinical trial conducted

for a coronavirus vaccine in India.

price of the likely MRP of Rs 500-600 /-.

Bharat Covaxin may also get emergency nodonce it sub-

Pfizer and Moderna’s vaccines use a short snippet of mRNA

with the same code as RNA from SARS-CoV-2, the coro-

mits data on Phase I and II trials. Bharat Biotech is in the

navirus that causes Covid-19. This mRNA is sort of like a

process of publishing data for the vaccine which is now in

blueprint: human cells can use the code to create a small

Phase 3 trails

piece of the virus, almost like a viral Lego brick. The "brick"

Meanwhile , government is framing terms of references

for two major bodies dealing with vaccine introduction–

the National Technical Advisory Group of Immunization

and the Central Drugs Standards and Control Organiza-

isn't enough to cause harm like a whole virus would, but it is

enough for the immune system to learn how to recognize

that brick and mount an immune response to fight off future

infections.

tion to look into grant of emergency authorization.

India need approx 50-60 crore to inoculate 25-30 crore priority population, categorized into 4 groups.


CORONAVIRUS SPECIAL

No to Remdesivir for COVID

advices WHO

The World Health Organization recommended against

using Gilead’s remdesivir to treat hospitalized Covid 19

patients less than a month after US regulators granted

the drug a speedy approval stating that there is currently

no evidence that it improves survival or the .

The global health body also suspended the drug from

its so called prequalification list. The prequalification

list is an official list of medicines used as a benchmark

for procurement by developing countries. This recommendation

is a blow to Gilead’s drug. The experts

made the recommendation after a WHO sponsored

global trial, called Solidatity, found that remdesivir

didn’t reduce death

Covaxin Technology

Covaxin is an inactivated vaccine derived from a strain

of SARS-CoV-2 virus isolated at the National Institute of

Virology (NIV), Pune. The inactivated virus is formulated

with ViroVax’s adjuvant to produce the vaccine

candidate. The widely used adjuvant Aluminium hydroxide

in the development of SARS CoV-2 vaccines is

known to induce a Th2 based response (which are important

for eradication of extracellular parasites and

bacterial infection). The Th2 based response has a theoretical

risk of vaccine associated enhanced respiratory

diseases (VAERD or ADE). The company

have used

Imidazoquinoline class of adjuvants (TLR7/8 agonists),

which are known to induce Th1 based response which

further reduces the risk of ADE (Anti-Body Dependent

Enhancement).

Research says Covid patients are infectious

for first nine days from onset of infection

According to a study published in

The Lancet Microbe, one of the

world’s top medical journals, no

live virus has been isolated from

culture of the respiratory or stool

sample beyond day 9 of symptoms

despite persistently high

viral RNA loads. This means that

a person affected by COVID 19 is

infectious for nine days after developing

disease symptoms. The

finding apply to critical patient

who are admitted to the hospital.

Additionally the increase deployment

of treatments, such as dexamethasone,

remdesivir as well

as other antivirals and immunemodulators

in clinical trails are

likely to influence viral shedding

in hospitalized patients . The

result also suggests that those

with milder cases may clear the

virus faster from their body.

The Lancert Microbe study also

suggests that people infected

with SARS0CoV 2 are mostly

likely to be highly infectious from

symptom onset and the following

five days . Therefore it is important

to self isolate, immediately

after system onset.

The Lancert study looked at key

factors involved in this: viral load

(how the amount of the virus in

the body changes throughout

infection), viral RNA shedding

(the length of time someone

sheds viral genetic material

(RNA), which does not necessarily

indicate a person is infectious,

as this not necessarily indicate a

person is infectious, as this is not

necessarily able to replicate), and

isolation of the live virus (a

stronger indicator of a person’s

infectiousness, as the live virus is

isolated and tested to see it can

successfully replicate in the laboratory).


REG-Q

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QUALPHARMA INTERNATIONAL

NEWS REVIEWS

Ayurvedic doctor’s authorized

to do surgery

PM Modi Warns Of Possible Side-Effects

Government brought a notification that will allow Ayurvedic

doctor to be trained and legally allowed to perform

a variety of surgery which include ENT, ophthalmology,

ortho and dental procedure.

Centre council of Indian medicine president said the surgery

have been going in Ayurveda institute for approx 25

years. The recent notification will provide clarity and legality

The notification listed the procedure that will be included

in the PG training of Ayurvedic Doctors by amending the

Indian Medicine centre council (PG Ayurvedic Education)

regulations 2016. During the course, post graduate scholars

of Shalya Tantra (General surgery) and Shalakya Tantra

(Surgeries of Ear, nose, throat, head and eye) will be practically

trained to perform various surgical procedures independently.

General surgical procedure included amputation of gangarene,

skin grafting, laparotomy (opening up of the abdomen)

and many advanced gastro-intestinal surgeries.

Prime Minister Narendra Modi

warned on Tuesday that any

COVID-19 vaccine could lead to

side-effects in some people, as

even popular medicines do, and

that the government would only

go by science in finalising one

for the country.

PM Modi said both speed and

safety were equally important in

launching a vaccine, but that,

once established scientific processes

had determined the right

path, India would follow it.

"Even medicines popular for 20

years and used by hundreds of

thousands of people lead to

reactions in some, even today,"

PM Modi said in a video conference

with the chief ministers.

"It's possible with vaccines too.

Any decision on them should

only be weighed on a scientific

scale. Whatever vaccine makes

it through the world's certified

processes, we will have to accept

them and move ahead."

The Serum Institute of India

said it would first focus on supplying

its home market in the

next few months.

The other experimental vaccines

on trial in India are the

government and Bharat Biotech's

COVAXIN; Russia's Sputnik-V;

Zydus Cadila's ZyCoV-D

and lastly one that Biological E.

Ltd is developing with Baylor

College of Medicine and Dynavax

Technologies Corp.

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OM SHREE GANESHAYA NAMAH

ZODIAC PREDICTION

PREDICTIONS FOR December 2020

By Astrologer Sudha Agrawal

PREIDCTIONS FOR December

2020

ARIES (MESHA)-----{NAMES BY AA, LA,

EE, I}:-

Aries Horoscope is not beneficial

for career progression. You fail to

enlist the support of seniors and

associates. This will prevent you

from sticking to your targets. Even hard

work will not be remunerative. Travel for

professional purposes will not be gainful.

You can only work hard and wait for the

arrival of good tidings

TAURUS (VRUSHABHA)-----{NAMES BY

BA, VA, OO, U}:-

Taurus Horoscope forecasts an

encouraging month for career

progress. You will have the support

of colleagues and the management

in your efforts. People engaged

in fine arts and creative fields will make

good progress in their fields. Travel for

professional purposes will help career

growth. Relationships in the workplace

will be quite harmonious. This will help in

achieving targets easily.

GEMINI (MITHUNA)-----{NAMES BY

KA, CHHA, GHA}:-

Gemini Horoscope indicates

that the month is encouraging for

career growth. Professionals will

have the backing of seniors and

colleagues for discharging their duties.

You will be able to reach your targets easily.

Your efforts will be rewarded generously.

The environment at the workplace

will be extremely pleasant.

CANCER (KARKA)-----{NAMES BY

DA, HA}:-

Cancer Horoscope foretells that

there will be major alterations in

your career profile. If you are not

happy with the job, you will go in

for a new job. There may be a change in

career responsibilities in the same organization.

It is also possible that there will be

changes that may last for quite some time.

LEO (SIMHA)-----{NAMES BY MA,

TA}:-

Leo Horoscope for professionals

presents a pleasant scenario.

You will be able to accomplish

your projects easily. Relationships

with colleagues and the management

will be extremely cordial. Social contacts

will help your career prospects. The only

precaution you should take is that you

should not abuse your authority.

VIRGO (KANYA)-----{NAMES BY PA,

THA}:-

Virgo Horoscope is not optimistic

about career prospects this

month. You fail to get the support

of family and friends. The environment

at the office will not be cordial.

Because of the non-cooperation of colleagues

and juniors, targets cannot be

achieved easily. Hard work does not result

in any rewards and there will be no promotions

or salary rises.

LIBRA (TULA)-----{NAMES BY RA,

TA}:-

Libra Horoscope is not very

much promising for career prospects.

Professional development

will be delayed by a focus on

family issues and psychological stability.

At the workplace, the atmosphere tends to

be highly conflicting due to the negative

attitude of associates. You fail to achieve

your targets. Even professional travel will

not be successful.

(VRUSHCHIKA)-----{NAMES BY NA, YA}:

Scorpio Horoscope predicts that

there will be very good opportunities

for career growth through

change of job. The change of job

may be in the same organization or you

may look for opportunities outside. Things

happen for the better in strange ways.

SAGITTARIUS (DHANU)-----{NAMES BY

BHA, DHA, FA}:-

Sagittarius Horoscope is not

encouraging for your professional

development. Financial

rewards are not in proportion to

the hard work you put in. The environment

at the workplace is hardly congenial.

Hence you will have a problem sticking to

your targets. Even professional tours will

DECEMBER 2020

not help your career growth.

CAPRICORN (MAKAR)-----{NAMES BY

KHA, JA}:

Capricorn Horoscope is not

favorable for career growth. You

will be putting in more work, but

the rewards are negligible. Social

contacts and family members will not be

able to help your prospects. Professional

travel will not give the desired benefits.

Under these circumstances, you should try

your best and wait for good days!

AQUARIUS (KUMHA)------{NAMES BY

GA, SHA, SA}:-

Aquarius Horoscope is quite

beneficial for professionals

and their growth. You will

have the support of social contacts.

Your diligence will be rewarded

with good financial remunerations. The

atmosphere at the workplace will be delightful

and you will have no problem in

sticking to your schedules.

PISCES (MEEN)-----{NAMES BY DA,

CHA, JHA, ZA, THA}:-

Pisces Horoscope for career

indicates that the professional

life will see enduring changes

for the better. Both the eclipses

will cause some anxious moments before

the modifications occur. There may be

important changes in the corporate structure

of your present organization or other

associate companies. All these will help

you to improve your hierarchy in the company.

~Sudha Agrawal


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