Advice Pool - Reference and Education

Enter a classroom in any abacus center in India and you will see children busy with something that looks like a toy — tiny brown beads compiled neatly in colum

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ns. On the wall is propped a similar toy, though bigger with large, shiny yellow beads.

The teacher calls out a complex calculation, almost like an open chall

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

enge. A little boy, barely seven, comes forward and recites a seemingly funny rhyme. He also moves the yellow beads up and down and gets the answer down pat. N

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

o furious adding, counting or subtracting! Amazed?

Welcome to the world of abacus education, where rigid arithmetic takes a backseat and visuals and imaginati

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

n gain centre-stage. Here children learn to use the abacus, an ancient Chinese invention, to solve basic arithmetic sums with speed and accuracy. Institutes, w

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

hich offer abacus education, claim that they use arithmetic as a tool to develop mind skills, memory and lateral thinking abilities.

Popular in Asian countrie

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

s like Malaysia, Taiwan and Thailand, abacus education is relatively new in India. But several entrepreneurs have been quick to tap the business potential of t

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

is non-formal education tool.

Scientific theories associate the left hemisphere of the brain with numerical and academic abilities, and the right hemisphere w

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ith creativity and intelligence. Proponents of abacus education claim that while formal education focuses merely on left-brain development, the abacus brings a

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

bout "whole brain development".

"If the brain is not developed at an early age, one's mental abilities can start declining by 20 years of age. That's why we m

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

st tap them young," says Dhaval Shrimankar, CEO, NurtureMinds.com.

The brain gyms — as these institutes are called — are not stand-alone entities, but, instea

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

d, operate through a network of local franchises in urban and semi-urban areas. The reach and popularity of abacus education can be gauged from the burgeoning

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

franchisee network.

Today, the same innovative education is available in the US and Canada. The system has taken the home-school communities by the storm. Pri

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

vate centers just like Score or Kumon are springing up from west coast to the east coast.

As an alternative to investment for a franchise, books are directly

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

old to the interested customers. Many of the patrons take up on roles of tutors as well as franchise owners.

How does Abacus work?

The abacus consists of 13

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

vertical rods, separated into two sections by a horizontal bar. Each rod contains one bead in the upper section and four beads in the lower section.

When give

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

n a sum, the child recites a rhyme corresponding to the kind of calculation involved. This also makes learning fun and easy. Simultaneously, the child moves th

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

required beads up and down. The position of each bead signifies a specific numerical value. At the end of the rhyme, the position of the beads touching the ho

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

rizontal bar, gives the answer.

As the course advances, the abacus is taken away and the child is encouraged to picture the abacus mentally to come up with th

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

e answer. After sufficient training, the child becomes adept at moving the beads mentally and no longer needs to recite the rhyme aloud to arrive at the answer

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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