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I see her there before me, in my religious imagination. In Ansel Adams black and white, she kneels in a rushing river. She clasps her aged hands in prayer, eyes closed, head slightly cocked.

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

She wears a thin cotton garment, a sari, and a matching scarf. Both are soaked by the river and its spray. She is a vision of prayerful serenity. I want to know her; I want to experience her

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

Examples of combination products may in

eace.

I do not know this woman. I think she must be in India, a Hindu. Judging by her clothing and the river, I think she wades in the Ganges. Beneath consciousness, I form other mor

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

spiritually intimate assumptions. For example, since I think she is Hindu, she may be praying to Krishna, Shiva, Kali or one of the multitudes of names by which <

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

>Hindus know God. Yet, all this runs through my mind without benefit of knowing her, of approaching her and entering into her soul’s delight and her mind’s illumination.

His Holiness,

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

Combination pro

the Fourteenth Dalai Lama says, “Peace means genuine tranquility. I think genuine peace must come on the basis of mutual trust, mutual respect.” His sentiment does not conflict with C

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

rist’s life as narrated in the gospels. I reflect on Christ’s compassion and values as he conversed with the woman at the well. She was an outsider to the Pharisees, yet Christ<

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

b> protected her from their anger. And she was moved in her soul. I take a tentative first step from my secure bank of rational thought and slowly ease my way into the foreign currents of he

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

faith. She is watching me, the hint of a smile and a glint of merriment in her eyes. I stand before her, not yet kneeling. “The water’s quite warm,” I say, surprised. She smiles and does not

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

reply.

Imagine: She and I, sitting on a lotus blossom that is suspended above the swirling waters of wholeness (holiness), our hearts opening to one another, radiating the pure light of joy

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

us understanding. I need to know how to proceed so that she will not sense any threat or disrespect. The answer comes to me in a whisper of realization: Proceed with humility.

We begin to e

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

Following aspects would a

change our respective beliefs about God. She is praying to Kali, Hinduism’s Black Goddess. Although I am open to a new approach to prayer, my cultural conditioning is challenged

dd to the challenges in developing combination products:

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

I try to describe Christian faith and monotheism; she begins to look somewhat mystified as well. Is there any common ground here? I say that the Christian belief in God is grounded in

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

the notion of one God. One and three: Father, Son and Holy Spirit. Overwhelmingly, the Divine is personified as masculine.

My new friend wrinkles her brow, considers this, and shakes her he

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

d. No feminine deities? No, I reply. I do not understand, she tells me. The Goddess Kali, who is but one of the many faces of Brahman. Kali is the mother of liberation. My Hi

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

du companion cannot understand how Christians can limit themselves to so few experiences of God’s infinite power.

Perhaps a simple Hindu woman in prayer and an inquisitive

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

Professional from academic institutions, pharmaceutical industries, health care indust

oman from the Christian west can achieve a glimmer of enlightenment in the river of our coming together. She listens to me with nothing more than acceptance and curiosity. I hope that

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

I have done her the same courtesy. I sense I do not have to cast away all that my heritage has taught me about God. My ideas about God represent but one view of a multi-dimensional reality.

.

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

inal image: My Hindu friend and I have formed a community of two. We hold hands and help each other out of the river and up the riverbank, still part of the Hindu universe, stil

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

Companies that provide selfless information through particip

rotating on a Christian axis, yet open like the lotus and ready to spread our fragrance as we pass through our very different days. Where will we go from here?

As we part, she smiles

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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