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The term ‘mantra’ literally means chanting of words, phrases or syllables. From mantra comes Mantra Yoga, which is a type of meditatio

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

n that involves the chanting of mantras. The chanting continues until the attention span of the chanter surpasses the physical environ

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

Examples of combination products may in

ment and enters a stage of super consciousness. In this stage, the emotions and thoughts of a person get elevated to a high degree of

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

clarity and revelation.

Mantras are an effective way to reach super consciousness because they help the mind to calm down and move aw

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

ay from daily distractions. The sole object of meditation is then fully realized and achieved. Chanting mantras have a soothing effect

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

Combination pro

, and the combination of the meaning and rhythm of the mantra helps your thoughts to settle into the meditative state. This ritualisti

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

c chanting helps bind the mind to a single thought until it attains the state of samadhi or self-realization, which is at the peak of

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

he practice of Yoga.

Achieving Samadhi through meditation is a slow process, and requires great patience, concentration and practice.

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

Mantra meditation usually proceeds in three stages. First, you begin by chanting the mantras out loud, ideally in an isolated space.

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

Saying the words and phrases out loud draws your attention away from other distractions and trains your body to sit still in a single

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

place while meditating. Once the body is relaxed and the mind serene, the chanter automatically switches to whisper chanting. In whisp

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

Following aspects would a

er chanting the prana, the vital life force in the body, is balanced and harmonized, preparing the way for the balance of mind and emo

dd to the challenges in developing combination products:

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

tions. At this stage the person is highly relaxed and calm.

Once the chanter is completely comfortable with whisper chanting, the pra

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

na flows deeper through the energy channels or nadis, and you move to the stage of mental chanting. This highly advanced stage helps y

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

u get rid of all forms of distractions because as soon as unwanted thoughts and distractions crop up, the mantra is simply chanted in

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

the same area of the mind where the distraction is occurring. Soon also the distractions melt away and the mantra then begins to reach

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

Professional from academic institutions, pharmaceutical industries, health care indust

the border of super consciousness or samadhi. At this stage, chanting becomes a free flowing process that gives the chanter pleasure

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

and peace.

The highest stage of mental chanting is called the ecstatic stage, whereby you experience total peace and a feeling of ‘re

.

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

turning home’; you are in a state of continuous joy, which lasts for about 15 to 20 minutes after which you return to the ‘outer world

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

Companies that provide selfless information through particip

’. The words of the mantra filter-out in the mind and you reverse the whole process, going into whisper - and then out loud – chanting

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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