Advice You - Business

"The administration of President [Gloria] Macapagal-Arroyo has seen its share of political instability over the last five years. The most significant of these was the Oakwood Mutiny of

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

July 2003. Like most social movements manifesting unrest towards government policy, the Oakwood Mutiny was originally perceived to have long-term drastic effects in the economy. This wa

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

Examples of combination products may in

eventually proven to be untrue for the local and offshore IT industry in this country as the resilience of Philippine society prevailed in succeeding years.

Analysts found renewed gro

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

th for the remainder of 2003 and the event being relegated to being a mere nuisance," XMG Inc. told in a statement, as quoted by INQ7.net. The IT research firm also believes the recent

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

ronouncement of state of emergency, which has now been lifted, and the ruckus at the Philippine marine headquarters carry "no fundamental negative effects to (the country's) economic gr

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

Combination pro

wth."

In the short term, XMG expects some offshore contracts to be suspended or cancelled owing "to insufficient understanding of the real meaning behind events of social unrest in Phi

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

ippine society." But the sentiment will get better in less than a year so long as the country does not suffer further political unrest.

indicate that the state of emergency has minimal

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

impact on the country's outsourcing market. Service providers have continued to take on a "business as usual" attitude though they admitted that regular business meetings experienced di

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

ruptions due to political protests. Nasdaq-listed ICT Group, Inc., for example, revealed plans to expand its operations while eTelecare Global Solutions announced it will recruit over 3

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

000 new agents in the Philippines. Nevertheless, "the current situation in the Philippines heightens the need for companies to have multiple global sourcing locations and to have multi-

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

ountry, multi-location disaster recovery plans in place," PRNewswire quoted neoIT CEO Atul Vashistha as saying.

According to the Business Process Association of the Philippines, the Bo

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

Following aspects would a

ard of Investments and the Commission on Information and Communications Technology, the Philippine outsourcing industry is expected to create 103,000 new jobs in 2006, a 44-percent incr

dd to the challenges in developing combination products:

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

ase from 2005. This is in spite of the threat coming from other countries like India and China.

Additionally, the outsourcing industry is expected to bring in $3.7 billion in revenues

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

his year. Among the outsourced industries in the Philippines are information technology, call center work, animation and software development. All these sectors are bullish about the pr

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

spects of growth. The Philippine animation industry is currently a $40 million business, while the global animation outsourcing industry is valued at $72 billion. The BOI also noted a s

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

gnificant increase of information technology-related projects that registered in 2005. The biggest growth is expected in the outsourced call center with a projected 70-percent growth.

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

Professional from academic institutions, pharmaceutical industries, health care indust

he booming outsourcing industry in the Philippines is considered vital in keeping the country’s economy viable. The government recognizes this fact, which is why incentives had been dra

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

n up for foreign companies planning to set up offshore offices here.

The local outsourcing industry is seen to continue growing because of an ever growing demand from the United States

.

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 Philippines remains the most favored nation for outsourcing ventures, after India because of the Filipinos’ excellent knowledge of the English language as well as their familiarity

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

Companies that provide selfless information through particip

with Western culture owing to the country’s historical affinity. Another factor is the Filipinos’ culture of hospitality which allowed them to carve a niche for quality customer service

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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