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I recently had the pleasure to interview Richard Rudis, a Buddhist who has traveled to Tibet many times, who also t

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

eaches people how to work with Gongs, Tingshas, and Tibetan Singing Bowls.

One question I asked him was about 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

fact that lately it seems that everyone and their brother is offering Tibetan Singing Bowls for sale. I asked Rich

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

rd to discuss this phenomenon:

Richard: In regard to the singing bowl proliferation, we should start in India.

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

Now, India is a wonderful country and it is full of wonderful opportunists. If there is a way of financially gain

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

Combination pro

ng from anything within their realm of understanding, they are on it in a moment.

So in India there are warehouses

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

full of what are referred to as “singing bowls" or "Tibetan bowls." They have been machined. They are not hand

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

ade like real Tibetan Singing Bowls. The alloy that real Tibetan bowls are made from is sacred in origin; I have

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

no idea if these bowls are made from same alloy, but probably not. For example, the iron in ancient bowls is mete

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

rite iron.

That’s not to say that some of these Indian bowls can’t be useful. It is just that they are being marke

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

ted in a way that is not completely honest.

There are only three sources in the United States that I can recommend

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

Following aspects would a

where someone can go and say I want a Tibetan Bowl, and get a real one. There were two groups in Tibet that made

dd to the challenges in developing combination products:

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

hem, and the groups have not existed for over a hundred years, so if the bowl was truly made by them, then the bowl

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

s are at least 100 years old.

The research I’ve done shows that the fourth Dalai Lama, separated these special bow

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

s from drinking bowls, so we can date true bowls back from at least 100 to over 1000 years ago.

The older bowls co

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

ming from that spiritual path, they are spectacular. But there are a finite number of them, so when you see all th

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

Professional from academic institutions, pharmaceutical industries, health care indust

se bowls out there, the sources have to be questioned. You need to use a lot of discernment and knowledge.

I do wo

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

rkshops over the country and people will bring me a bowl they have and to them, it’s a wonderful bowl in their mind

.

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

But once they experience a true quality bowl that I bring to the workshop, the bowl that they thought was great n

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

Companies that provide selfless information through particip

ow becomes mediocre. It can still work for them in many ways, but it is not the same bowl they once thought it was

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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