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Everyone is today concerned about globalization. Love it or hate it, globalization is here to stay! Even political parties that are left behind are willy, nilly forced to admit that it is a phenomenon that is well and truly out of the bottle ! Technology has done what idealogy could not : unite us all into a fraternit

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

y of interconnected and interdependent communities.

How do traditionalists deal with such a new world order ? The short answer is that they cannot because their analytical frameworks are incompatible with current realities. Moore’s law for example, has ensured that the frontiers of knowledge are constantly expanding.

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

Examples of combination products may in

The law postulates that the density of information that can be packed into a computer chip doubles every 18 months or so. This means that computing power is doubling every 18 months thereby enabling undreamed of advances in science, technology and knowledge in general. Who would have thought that it was possible to un

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

ravel the mystery of life by cracking the hitherto undecipherable genetic code ? Perhaps the best is yet to come because the pundits expect Moore’s law to be valid till the year 2017 when the limits of computing as we know it would be reached. That’s when sub-atomic computing is expected to take over and keep computat

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

onal power growing.

All this inevitably means that human beings are getting even more connected every day. Some observers are convinced that the greatest technological marvel of the last century was not the computer chip but the Internet. This is in turn means a networked and therefore globalized world. So, to us in

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

Combination pro

ndia what are the implications of globalization ?

Change is always open ended so its hazardous to venture into predictions. However, to me, some implications of globalization for management are clear.

Firstly, globalization means a convergence of standards. Therefore, parameters for quality and performance are now n

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

ot related to our local conditions but to the global norms. This is simply because the markets are global. Therefore, success in these markets demands delivery of global standards, nothing less. There is no hope for any product or service or indeed any organization that does not adhere to global standards even if they

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

are being produced for Indian markets. After all even the Indian markets have gone global because the barriers to entry have been cleared in virtually every industry. The lesson is clear: you cannot survive with lower standards because your competitor is offering global standards to your customer.

Convergence of stan

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

dards is undoubtedly an effect of technology and competition but it is also equally being driven very proactively by several high power global institutions. For example, the WTO is fostering a transparent rule-based global trading system. The Bretton Woods twins, World Bank and the IMF, are ardent advocates of pruden

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

economic development, trade , fiscal, monetary and other macroeconomic policies; while their prescriptions do not always find ready acceptance or relevance in every country, they are respected sources of research-based advice on sustainable development. The Bank for International Settlements is actively crafting the

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

tandards for the global banking industry while the International Standards Organization contributed norms for globally accepted standards for quality (ISO 9000 series) and environment management ( ISO 14000 series).

Secondly, productivity growth will accelerate in India because of the pressure of competition. This wi

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

Following aspects would a

ll ensure that the laid back approach to work is over, the number of holidays will be slashed and the proliferation of computers across India will accelerate. This is turn will fuel all aspects of the knowledge economy: education, training and services. Though it is fashionable to talk about the global market for soft

dd to the challenges in developing combination products:

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

are, I am convinced that a significant part of that market is right here in India. The need to increase productivity in every segment of the economy will spur a huge growth in the Indian software industry.

Thirdly, profit margins will narrow to global levels. It is now futile to expect that the usurious margins of th

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

e past (20 to 50 %) to continue. Competition from global players in the now opened Indian market has eaten into the traditionally high margins. Soon, companies will have to learn to operate at net margins of around 5 %. Already interest rates have fallen and the benefits have passed through to customers in the form of

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

stable or lower prices. Profitability will now have to come from lower costs from higher volumes and productivity gains. The possibility of raising prices frequently is now more or less like a mirage in the desert. This global reality however does not appear to have sunk in among the ownership and top echelons of man

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

gement in many companies in India.

Fourthly, if globalization teaches us anything, it is easy information availability and its effect : transparency. Leaders in politics, corporate boardrooms and markets can no longer hide behind opaque shields. Internet, email, data archiving and convergence have ensured that everyb

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

Professional from academic institutions, pharmaceutical industries, health care indust

ody has access to almost everything. For India, the hope of decreasing corruption is now brighter than ritual, moralistic pontification by the psuedo leaders: all the shenanigans will be listed in the public domain and neither the power of the state nor the power of money can stifle the stink. Open societies and the I

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

ternet mate to father transparency. Therefore corporate governance, governance by government and compliance all become de facto standards.

And finally, globalization offers the real possibility of improving quality of life for our people by arresting if not reversing the continuous migration from villages to cities.

.

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

This can happen when the Indian economy becomes not an agricultural economy or an industrial economy but a knowledge economy. We can create the possibility of people earning comfortable livelihoods in their own villages and communities. Therefore, universalization of IT literacy has now to be attached to universalizat

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

Companies that provide selfless information through particip

on of primary education. There are very few justifiable subsidies left. However a provision for a subsidy for connectivity and IT literacy in the Union Budget is an idea whose time has come. Surely, this is an investment that will have a huge ROI in the future. After all globalization is all about creating the future

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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With the number of small businesses increasing by the day, the competition from larger companies is also getting tough. If you own a small business, chances are that you have faced stiff competition from some mall, supermarket, or department store at one time.

While most people experience interview nerves at some point in their career, they are not a requirement for interviewing. In fact, you can calm those anxious nerves using a few simple techniques.

There are many ways to get an extra income if you cannot afford to work ‘normal’ full-time hours. This article will show you what is available and what you should avoid. I will use student time as an example, as a student’s timetable is usually the most ‘inconvenient’ for full-time work and also changes every semester. However, the opportunities outlined in this article can also apply to other demographics, e.g. single mothers.

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