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Promoting Innovation Approach.

The agriculture sector continues to evolve based on shifting

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

demand patterns, improved technology, integrating trade, and the market. Learning from the in

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

Examples of combination products may in

ustrial sector, the Bank is exploring innovation systems approach to address the demands and

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

orces that impact agriculture. The agriculture portfolio targets integrated programs that add

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

ess science, private sector investment, the financial system, the policy and regulatory envir

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

Combination pro

nment, and stakeholder participation. Commitments to agricultural research, extension, traini

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

g and education components (AKIS) have increased from $230 million in FY04 to $282 million in

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

FY05 to $499 million in FY06. 48 percent of this lending was towards agricultural research.

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

e-engaging in water for agriculture.

Agriculture accounts for nearly 80 percent of global wa

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

er use. To gain “more crop per drop,” the Bank is proactively re-engaging in investments that

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

target the policy, technical, and governance aspects of agricultural water. The Africa Action

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

Following aspects would a

Plan identified managing water for agriculture as a priority. Investments that empower local

dd to the challenges in developing combination products:

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

ser groups and promote public private partnerships are critical to improving performance in t

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

is subsector.

Emerging zoonoses – a global threat.

Animal-based diseases, such as avian flu

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

and ‘mad cow’, continue to keep livestock management and animal health at the top of the deve

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

opment agenda. Twenty seven countries have received financing under the Bank’s $500 Million G

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

Professional from academic institutions, pharmaceutical industries, health care indust

obal Program for Avian Influenza (GPAI) through January 2007, with 16 of these country projec

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

s being approved since July 2006. Effective compensation schemes to induce early reporting an

.

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

culling are key to avian influenza control strategies. The Bank, FAO, and OIE released guide

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

Companies that provide selfless information through particip

ines for such schemes to be managed by client countries and partner agencies in December 2006

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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