Advice You - Business

Business environment in India is a bit different from the business environment in many developed countries; India has a boutique business environment. More specifically, procedures

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

to get various administrative tasks done aren’t exactly straightforward. They are arbitrary and a lot of human communication can get involved; bribing is one of examples. Understan

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

Examples of combination products may in

ding the environment itself takes time, and actually maneuvering in the environment is quite difficult. It’s unlikely that those from foreign countries can smoothly get administrati

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

ve tasks done. Furthermore, while I’d risk saying that most Indian people are honest and hardworking, it is easy for foreigners to get tricked by some bad apples; they might not be

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

scammed and have a lot of money stolen, but they can easily overpay for various services. For this reason, it is advisable that you hire a reliable street smart to assist you to run

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

Combination pro

a business in India.

Having a dependable accountant and a banker is essential in India even if you run a small business, and you need a street smart to find a dependable accountant

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

and a banker for you. When you run a business in any country, it is ideal that you have a dependable accountant and a banker; however, this is not only ideal but also it is very cri

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

tical in India, while having a dependable accountant and a banker is not absolutely necessary to run a (small) business in a developed country. To describe briefly, accounting and b

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

anking are more complex in India than accounting and banking in many developed countries; one of reasons is corruption. Corruption is everywhere, so this makes accounting and bankin

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

g very confusing and tricky, and thus, you definitely need to get help from a dependable accountant and a banker.

Corruption is everywhere, that is, bribing is everywhere, and you n

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

ed a street smart to pass bribes for you. Every single administrative task requires you to pass a bribe to the public official who takes care of it. Also passing small gifts is not

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

Following aspects would a

an uncommon practice; this often enables you to get administrative tasks done much faster and without a lot of hassle. The problem, however, is not bribing or passing gifts as far

dd to the challenges in developing combination products:

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

as you are concerned; the fact that you do not know exactly when or how to pass bribes or pass gifts is the problem. This is when you need a street smart.

There are emergencies and

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

they are bound to happen, and this is arguably the most important reason why you need a street smart to assist you. For example, you might become very sick, and you need to see a g

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

ood doctor to get well. A certain financial transaction might not be going through for variety of reasons, but you might have to get it done somehow. You might need to create a cou

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

le of documents from thin air to get a certain administrative task done. There are many emergencies, and creativity is often required to get through emergencies, and you need a stre

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

Professional from academic institutions, pharmaceutical industries, health care indust

et smart who can help you with his/her creativity.

I emphasize that most Indian people are honest and hardworking; also India’s economy is growing rapidly and there are a lot of gre

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

at business opportunities. However, that doesn’t change the fact that the business environment in India can become quite difficult for those from developed countries to maneuver aro

.

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

und. It is essential for them to learn as much as they can, but I highly doubt if they can learn to maneuver around in the complex business environment in India; even if they can le

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

Companies that provide selfless information through particip

arn, they need a lot of time to learn. In many instances do you need to get things done regardless in business. For this reason, get a street smart when you run a business 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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