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In ancient times researchers of Soul Sciences very intricately discovered conscious principles of the subtle world. In this very human body (microcosm) they found the mirror-image of the material world (macrocosm). Whatever one perceives in the gross world is present in the human body in a subtle form. Hence instead of carrying out research studies pertaining to the external world with the help of very expensive scientific technical apparatus, the ancient seers/sages looked upon the human body as a reflection of the gigantic cosmos and hence conducted research studies by diving deep into their souls within the body.

These ancient seers and Yogis while conducting research in the field of Soul Sciences concluded that amongst all spiritual practices (Sadhanas), activation of Kundalini Mahashakti or Divine Serpent Power is most important. After under

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

standing the nature of the Divine Serpent Power along with its apt utility power, it was noted that Kundalini controls 2 main centers within the human body. These 2 centers are powerful as the 2 poles of the planet earth viz. the North Pole and the South Pole. Kundalini activation involves mastering of these 2 centers/poles in the human body. This spiritual practice involves many small/big experiments and then applying their results. There are certain very easy experiments which when executed can make a person radiant, brilliant and positively active. There are other difficult and high leveled experiments pertaining to Kundalini Activation. Such methods make the inner soul of a person so all-pervasive that he can contact all the Divine Powers of this gigantic cosmos. This cosmos overflows with extraordinary powers but laymen do not have the capaci

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

Examples of combination products may in

ty to understand and utilize them for material and spiritual progress. But when a person via Kundalini Activation comes in contact with all these cosmic powers, he can make use of all of them as per his requirements. Apart from this such an exalted soul can influence the entire cosmos so as to benefit the world both materially and spiritually.

A medium activation of Divine Serpent Power produces a lightning-like electrical flow in the human body. I have personally known a Sidha (realized saint/sage) whose body was filled with material electricity continuously. No one could touch him. If anyone dared touch him, he would experience an electric shock that one gets by touching naked wires. This realized saint always kept his eyes in a drooping state. This was because if anyone made eye-contact with this realized saint, he would become unconscious. On

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

ce, this realized saint stared at a piece of glass and instantly the glass piece cracked into tiny pieces. This was the result of the glass contacting the bodily electricity of that realized saint. When this electrical flow touches the psyche, one overcomes all limitations of the mind. When Valmiki contacted the divine mind of Narad and Angulimal that of Lord Budha both ferocious dacoits surrendered unconditionally at Narad’s and Lord Budha’s feet respectively. As a result they gave up their vile activities and instead lived lives of sages. Yogic spiritual practices can create infinite power in the gross, subtle and causal bodies of the body, mind and soul respectively. It goes without saying that Kundalini Activation is the most important aspect of Yogic spiritual practices. Even if one performs preliminary practices, one’s worldly life becomes r

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

adiant and glorious. It is difficult to describe the miraculous heights one reaches when higher levels of Yogic practices are imbibed.

From a gross standpoint the human body is a living and thinking mass of flesh. Its activities revolve around nourishing the body and procreation. The mind is immersed in greed, attachment and ego based thoughts. A living being immersed in satisfying desires, sometimes tastes joy and at other times despair. Thus he lugs the burden of life virtually like a donkey only to enter the jaws of death. One sometimes gets sense pleasures and at other times loses all of them. One keeps building and breaking contacts with other creatures of the world. There is no beginning or an end to the vicious circle of hope and despair. A living being like wet mud revolves around the wheel of a potter. Over here he loses or transforms hi

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

Combination pro

very existence. Man is very much a part of the cycle of creation, propagation and destruction of the world. Like all material objects man too undergoes this cycle.

The chemical analysis of the physical human body is very lowly and valueless. The market value of these chemicals is even less than animals, birds etc. sold in markets. If we try and sell man’s blood, flesh, bones etc. in the market we will get a price less than that obtained by selling a living hen. Despite this man is considered the glorious peak of creation. This is only because of consciousness dwelling in his body. This conscious energy can be seen as zest, might and beauty in the human body. The subtle body oozes with wisdom oriented glory, intellectual radiance and an enterprising mind. The ultimate casual body overflows with divine glories like faith, hope, love, service, gene

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

rosity, compassion etc. towards entire creation.

This conscious energy of all the 3 bodies, viz. physical, subtle, causal is said to be more potent than all the intense energy vibrations of heat, sound, electricity, ether etc. of material inter-stellar space put together. The ratio difference between material energy and spiritual energy is equivalent to the material potency measured by modern scientific apparatus and the soul power experienced by great Yogis within their bodies. We hear amazing talks regarding lasers, death rays, atomic energy etc. As against this if we deeply understand the creative potential of soul force, we will realize that it is impossible to measure it.

A very infinitesimal unit of the human body called the sperm has the capacity to produce a new human body. The atom is compared to the solar system. The microcosm (human b

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

ody) is said to be the representative of the macrocosm (cosmos). This is not only a fact but is an abject reality. Under such circumstances man’s very existence can be compared to that spark of fire which in its seed form has the capacity to burn up a gigantic forest. A seed has the potential to grow into a gigantic tree if it comes across conducive situations. In its true form it can generate innumerable other seeds.

There exist bipartite applications of divine energy. When it is purified thoroughly man becomes a saint, demigod or God Himself. He thus accesses all the Divine Powers of such divine beings. If this very Divine Power is used for material progress, a person becomes very brilliant. He reaches the peaks of progress and carries out gigantic tasks which were previously impossible to execute. Thus every step of his is akin to victory. The

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

bright pages of history radiate further due to the glory attained by such radiant, skilful and bright individuals. These eulogies pertaining to such divine men are not because of their attainments in the external world, but are based on the radiant conscious energy within their awakened psyche.

The science of advancing one’s conscious energy encompasses Yogic practices and austerities. Within the visible gross body lie 2 bodies called subtle and causal bodies and they cannot be seen by the human eye. The aim of Yogic or any other spiritual practice (Sadhana) is to make conscious, this otherwise unconscious or unaware subtle body. This will induce awareness/consciousness in the individual. One will overcome Maya (power of illusion) and become divine as a result of purification of the psyche. It is believed that when devotees, Yogis, men of auster

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

ities etc. attain Ridhi-Sidhis (Divine Powers), it is the result of blessings from demigods, ghosts, demons etc. But the reality is that whatever is labeled as amazing, extraordinary or extrasensory is nothing but manifestations from within our soul (Shri Aurobindo Ghosh writes in his poem “SAVITRI”: Logic in the infinite is magic in the finite). Purification of the mind/psyche is called God-realization or salvation. If we do understand this precept clearly, we will be called true knower of truth.

Soul based practices have many applications. Innumerous methods and paths have been laid down by many schools of thought. Within Indian Sciences of Spiritual Practices, 84 Yoga (union with God) are most important. Their branches and sub-branches could add up to a few thousand in number. Hence it is even more tedious to keep count of well-known spiritual

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

practices of other areas of this world. In Yoga practices, the path of Chakra activation is such that all over the world it has been widely accepted. Despite there being difference of opinion regarding the mode and nature of Chakra activation, people unanimously accept its existence and positive influence. Time and again activation of Kundalini Shakti i.e. Divine Serpent Power has been discussed within the arena of spiritual practices. This is the ultimate stage of success attained due to Chakra activation. We are all aware of the electrical energy that flows in the nerves of the human body. Telephone wires can only work if they are connected with electricity. It is the miracle of this very electricity that results in sensations perceived by our sense organs (eyes, ears etc.) and all ideas and sentiments in our brain. Layers of storms that manifes

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

Following aspects would a

t electromagnetic waves arise in our body and thus our moods experience joy or despair. One’s life is directed in a particular way which depends on this sort of an influence. Great Yogis have always endeavored to understand this divine conscious flow so that we can make apt use of it to augment our material and spiritual progress.

Research studies on conscious energy reveal that the Sahasrar Chakra (subtle 1000 petal plexus) present in the center of the brain, is akin to the North Pole of planet earth and the South Pole is the genital region at the base of the spine which is where one finds the Mooladhar Chakra (subtle plexus). These are the 2 bodily centers that are the medium of give and take with Cosmic Consciousness (God) and an individual contacting the latter. The divine energy within them is the axis of life’s very existence. The center of

dd to the challenges in developing combination products:

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

intellect and faith is above and the center of joy and might is below. The genitals are not meant merely for experiencing joy during sexual intercourse and producing children, because at the root of our genital organs lie artistic skills, daring, zest etc. These are said to be the basis of material progress. When a person loses this energy, he is denounced as a eunuch. Over here intense effort is described and not the act of sexual intercourse. The Mooladhar Chakra is the center of material powers.

The Sahasrar center of the brain is the root source of wisdom, intellect and other spiritual qualities. Spiritual practices like Pratyahar (cutting off the contact between sense organs and their objects for e.g. nose stops egoistically smelling things), Dharana (one-pointed focus of the mind), Dhyan (meditation on a single thought wave), Samadhi (tran

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

ce or Super Conscious State) are carried out in the brain region. A chain joins the Mooladhar which is a center of material powers and Sahasrar which is a source of spiritual powers. This chain is ordinarily called Merudand and in spiritual terms it is called Sushumna (subtle spine-according to Indian Yoga). What is the importance of the spinal cord? The answer is well-known amongst experts of Anatomy. Along with the electrical stream within the spinal cord, are conjoined high leveled divine glories. A realized saint or one who has experienced the cosmic soul (God) truly knows all this. In this center, flow intense electrical streams with great speed. It has 2 forms i.e. negative and positive. Ida nerve (subtle) is negative and Pingala nerve (subtle) is positive. When both these subtle nerves unite, we experience an energy flow which is called Su

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

shumna (subtle spinal nerve). It can also be called Naadi. Naadi is either a nerve or a blood vessel like arteries and veins. Over here it means a subtle nerve and not a gross blood vessel. In this Sushumna there are 2 electrical streams. Suppose a great surgeon opens up the spinal cord to see the Ida, Pingala and Sushumna, please note that he will see nothing of this sort! This is because the Ida, Pingala and Sushumna described in Indian Yogic scriptures are very subtle in nature. Thus no modern, material apparatus can prove its existence. These subtle nerves can only be experienced by an individual who has purified his mind so as to make it very subtle and focused. Very briefly these are 2 types of energy centers. One is in the brain (spiritual) and the other near the genitals (material). The electrical streams flowing in the Ida, Pingala and Su

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

humna subtle nerves are like a bridge that joins these 2 energy centers. Symbolically Ida, Pingala and Sushumna are compared to Rivers Ganga, Yamuna and Saraswati. It is called Triveni or 3-fold union.

When a river flows very speedily it tends to create eddies. When the atmospheric wind is hot and speedy, one experiences cyclones in the summer season. Just like eddies in a river and cyclones in wind, the conscious energy flowing in the Sushumna is said to be merely an intense stream of electricity. It is called an energy wheel. In Yogic scriptures it is said that there are 6 such energy wheels.

In Indian mythology called Puranas the symbol of effort and son of Shakti (divine energy) is said to be Kartikeya Skand. He is Parvati’s son, yet according to Shiva Purana it was Kritikas (Pleide Stars) who reared him. Agni (fire) retained Kartikeya in it

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

Professional from academic institutions, pharmaceutical industries, health care indust

s womb. Shiva’s Retas (sperm) manifested as fire and Vaishwanar (bodily hunger fire) in the form of a female, imbibed this Retas in her womb and nourished it. Yatudhanas, symbols of innumerous obstacles, had rendered the life of demigods full of distress. These Yatudhanas were defeated by Kartikeya Skand. This son of Shakti had 6 faces.

This incarnation of Skand should be understood as the description of the influence of the 6 Chakras related to Kundalini super energy. Kundalini or Divine Serpent Power is nothing but the substratum fire present in the root of our genitals. When Shiva in the form of Sahasrar is activated, it manifests honey-like pollen and this is Shiva’s Retas. Kundalini as the substratum fire held this Retas. The 6 Kritikas (Pleide Stars) nourished this Retas. These 6 Kritikas are the 6 Chakras. Thus this union of Shva and Shakt

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

i (Kundalini) results in the manifestation of the great warrior Skand. Skand has 6 faces. Kartikeya whose 6 faces are nourished by the 6 Kritikas, should be looked upon symbolically as the influence of the 6 Chakras (subtle plexuses).

The 6 Chakras are situated one after another in a vertical manner on the Merudand and the first one is situated in the genitals at the base called the Mooladhar Chakra. The last one called Sahasrar is situated at the top, in the central region of the brain called Brahmarandhra. This can be called a special powerhouse or microwave station. Above Mooladhar lies the Svaddhishthan Chakra in the navel region. After that comes the Manipur Chakra between the navel and heart region. Anahat Chakra is found in the heart region. Vishudha Chakra is found in the throat region. The Ajna Chakra is found in the center of the eyebro

.

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

w. Finally the Sahasrar is situated in the center of the brain region called Brahmarandhra. Thus if you include Sahasrar Chakra there are 7 Chakras (plexuses). These Chakras are described on the basis of the demigod, vehicle, color etc. of that region. This is so that when a spiritual seeker activates these Chakras, he can gauge which stage he has reached and how far has he progressed.

What are the 6 Chakras? Where are they situated? What is their state? What is their utility? One should at least understand the preliminary answers to the above questions. The application of its utility and teaching varies and a spiritual seeker is given that teaching which is conducive to his individual mental state. The Merudand ends at the root of genital organs. Between these two there is a hollow space which is called Yoni Kand in spiritual terms. Accordin

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

Companies that provide selfless information through particip

g to modern anatomists, the Sushumna nerve is merely a network. But according to subtle body scientists there lies a special bodily part in this region which is called the Mooladhar Chakra. Below this is a back akin to that of a tortoise. Hence it is called Kurma. Above it is the Merudand and is called Sumeru. Surrounding it is a serpent like energy principle lying coiled with 3 ? rounds. This is the Mooladhar Chakra. This can be explained as a ball or Kand situated in a pyre or cave. This is the first Chakra. This is the root area of Kundalini or Divine Serpent Power. Although the fire in a stove is extinguished when no more fuel is added to it, yet one can experience some amount of heat in its vicinity. Ordinarily this is the state of laymen. With effort when one adds the fuel of Prana (vital force), the fire manifests. Its flame travels upwards

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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