Useful Advices - Business

With severe power shortage problems predicted for the turn of the century, India was faced with finding a solution to

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

this problem either domestically or through foreign investment in the early 90’s. India’s financial standing in the

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

Examples of combination products may in

world markets was extremely low and had never been an attractive country for foreign investment. Enron Development

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

Corporation, a part of American Enron, believed they could solve India’s power problem through the construction of th

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

e gas-fired power station, the Dabhol Power Company (DPC), in Maharashtra. “The ENRON/Dabhol project represented Ind

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

Combination pro

ia’s biggest single foreign direct investment, and was intended to be showcase for India as a bankable country on the

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

global stage.” (Rangan & McCaffrey, 1).

India’s current governing body wants to open their infrastructure sectors (

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

ower, telecommunications, air transport and roads) to private sector companies. They believed the development of a s

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

trong infrastructure was required for the country to have a prosperous future. However, foreign investors were not s

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

ure if India was stable enough for their direct investment. A successful DPC would make India much more attractive f

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

or foreign investment, practically opening the door to country wide infrastructure growth. A strong infrastructure w

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

Following aspects would a

ould lead to economic development not possible in the current situation. Knowing how important Dabhol is to the econ

dd to the challenges in developing combination products:

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

omic future of the country, Enron was able to get the government to fast track the plant’s approval. The Indian gove

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

rnment consolidated the 17 civil agencies responsible for oversight into one agency, the Foreign Investment Promotion

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

Board (FIPB).

The government of India during this time had an economic agenda to pursue. They placed a very high va

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

lue on the DPC and was doing everything it could to make it a reality. The creation of the FIPB and the speedy appro

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

Professional from academic institutions, pharmaceutical industries, health care indust

val of the plant made the DPC seem as if it were a perfect fit for the country. However, when a more populist govern

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

ment took control of the country it announced that it was canceling the Dahbol power project. Eventually the new gov

.

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

erning party and Enron came to a compromised agreement. By using outside lobbying interests to fast track transactio

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

Companies that provide selfless information through particip

n approval, Enron was able to raise its negotiation power since many outside lobbying interests coincided with theirs

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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The end of the year is a great time to clean out your office and shred all those old records. Host an office shredding day to make it easy for everyone to shred the extra paper that has been building up.

Compensation Resources, Inc. (CRI) has released the results of its 2005 Year-End Compensation Survey. The purpose of this study was to obtain compensation data used for trending and planning purposes at companies of all sizes and shapes. Data was compiled from survey questions that were developed by CRI and distributed to companies in 16 industrial classifications, in addition to Not-for-Profit organizations. The survey sampled year-end compensation data from a variety of organizations, collected in October and November 2005.

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Useful Advices - India's Power Troubles And Enron

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