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We can definitely learn quite a few things by observing business practices in India If you are in one of developed countries and if you tell your friends that you are going to start a business, most of them would tell y

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

ou to think twice. This is because most new businesses in developed countries would fail within the first three to five years, and this is supported by statistics. India has a very poor infrastructure and also its poli

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

Examples of combination products may in

tical and economical environment is not as stable as that in developed countries; therefore, your intuition tells you that even more new businesses would fail in India. However, the situation is quite the opposite; most

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

of new businesses manage to survive in India. It is rather surprising, but if you look at various aspects of the business operation, you would logically conclude that new businesses in India are much more likely to surv

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

ive than new businesses in developed countries.

One of characteristics of new businesses in India is that they start with very small capitals or none whatsoever. New businesses spend what they can spend to start; in ot

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

Combination pro

er words, they have very little or no debt at the beginning. Since there is very little or no debt, new businesses have no obligation to make payments to any lenders; this dramatically increases their chances of surviva

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

l. On the contrary, new businesses in developed countries often take huge debts to start. It is partly necessary but it is also partly a common practice, although new businesses do not necessarily have to follow the co

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

mmon practice. For example, it is very common for new businesses to heavily invest in new pieces of office furniture, while they are totally unnecessary in most cases.

As I look at individual businesses in India closel

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

, I find that many businesses in India have very low operating costs. I see used computers everywhere. I see old furniture everywhere. Most offices do not spend a whole of money to make them look pretty. Most offices

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

do not spend money for decorations. For example, a friend of mine (in India) runs a printing business; the business produces customized business cards, letterheads, envelops, calendars and booklets. Its office has no

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

andline phone; it has no computer. The office only has bare necessities. This obviously keeps the business’ operation cost very low. On the other hand, many new businesses in developed countries keep their operating c

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

Following aspects would a

osts much higher than necessary. For example, a friend of mine in US used to run a business from his apartment; it was a small business, yet he had a number of equipments, each of which costs thousands of dollars. He h

dd to the challenges in developing combination products:

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

ad a couple of cell phones, a couple of laptops and a couple of desktop computers. The operating cost was a lot higher than necessary. (He went out of business and the high operation cost was one of reasons.)

Family s

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

ructure in India is very strong, and this is quite helpful for new businesses. It is difficult for new businesses to find trustworthy people who can help them; it is even more difficult for them to find free help. Sinc

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

e family structure in India is very strong, they can often get help from their family members in many cases. Family members help other family members’ new businesses for free even. This is not exactly the case in devel

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

ped countries. Family structure is relatively weak, and it is very difficult to get help from family members.

While the political and economical environment in India is not as stable as that in developed countries, the

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

Professional from academic institutions, pharmaceutical industries, health care indust

re is actually one political advantage. Rules and regulations in India are relaxed when it comes to providing protections and benefits to employees; also licensing costs and other regulatory compliance costs are very lo

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

w. This makes the recurring cost very low, and this increases new businesses’ chances of survival. While many of developed countries offer very generous social programs, they also put heavy burdens on businesses such a

.

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

the financial burden of providing protections and benefits to employees. This raises the recurring cost, and this makes new businesses to survive even more difficult.

While we cannot easily change laws, rules and regu

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

Companies that provide selfless information through particip

lations, we can lower our operating costs. We can also start new businesses using whatever money we have instead of borrowing heavily. We can definitely learn quite a few things by observing business practices in India

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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