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Slowly and steadily the use of Chinese medicine and acupuncture is gaining populari

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

ty in all parts of the world. Since President Nixon made his historical visit to Ch

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

Examples of combination products may in

na in 1972 and effectively opened the door from East to West, America has been unde

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

rgoing an acupuncture craze.

Acupuncture is a vital component of the traditional C

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

inese medical system, wherein needles are inserted into the skin and underlying tis

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

Combination pro

ues, to treat an illness. A very ancient art, acupuncture has gained wide popularit

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

y as an alternative medicine over the past forty years. With such encouraging and p

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

omising results, the use of acupuncture has found a space not only in Chinese medic

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

l system and the developing countries, but also in developed nations like the US.

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

To spread this knowledge and education in the field of acupuncture, a number of acu

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

uncture schools have opened up in different countries. The acupuncture schools aim

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

Following aspects would a

t educating students; training them to be healers in the art, science and philosoph

dd to the challenges in developing combination products:

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

y of acupuncture; and to be instructed in herbal and Oriental medicine.

The number

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

of acupuncture schools in the United States has grown at a high rate since the crea

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

ion of the Accreditation Commission for Acupuncture and Oriental Medicine (ACAOM) a

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

nd the Council of Colleges of Acupuncture and Oriental Medicine (CCAOM) in 1982. Ac

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

Professional from academic institutions, pharmaceutical industries, health care indust

puncture schools offer a variety of graduate and undergraduate programs for student

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

seeking a career as an acupuncturist. Acupuncture school education and training i

.

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

s approximately 3,000 credit hours.

Attaining a professional license as an acupunc

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

Companies that provide selfless information through particip

urist, after taking up one of the courses in acupuncture, is rewarding in many ways

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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