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When the slaves were brought to Cuba they also brought their religious beliefs with them. There were 4 major Groups of Africans that were brought

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

as slaves to Cuba. The Bantu people from the Congo Basin were the largest population of the slaves imported to Cuba. There was approximately 40

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

Examples of combination products may in

,000 Bantu people brought to Cuba as slaves. The next group was from Nigeria. They were the Yoruba people from Southwestern Nigeria. An estimated

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

275,000 slaves were imported to Cuba from Nigeria from 1820 to 1860, which corresponded to the fall of the Oyo Empire. The next were the Carabal

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

also known as Abakua people who were basically Igbo and Ijaw people from Southeastern Nigeria. They arrived in Cuba in the late 1700’s to early

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

Combination pro

800’s at a population of 240,000. The last of the main groups to come to Cuba as slaves from Africa were the Arara people. They were of Fon, Ewe,

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

Popo and Makhi origin. They came from Dahomey and its surrounding areas in a population of 200,000. There were other groups from Africa as well

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

ut in small amounts compared to these 4 groups.

The Bantu Afro-Cuban religion was called “palo” or sticks by the Spaniards. This is because the

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

Spaniards noticed that the Bantu were always gathering Sticks and Barks for their purposes. “Santeria” which is actually a derogatory term, is a

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

erm that was used by the Spaniards to depict any one that they believed put saints before god.

Contrary to Christian and European comprehension

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

f African religious beliefs, the Afro-Cuban religions in their various forms all have a supreme “god” like the Christians and Europeans understan

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

Following aspects would a

d god to be. For the Bantu god is called Nsambi and to the Yoruba/Lucumi people god is called Olodumare. Like Christians who have saints that are

dd to the challenges in developing combination products:

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

god’s emissaries, all of the Afro-Cuban religions have deities that are god’s emissaries. The difference is that Afro Cuban religions believe in

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

the forces of nature and that the deities control nature as well as peoples lives. They also incorporate the concept of ancestors and their purp

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

se of spiritual existence is with the living as part of their religious belief systems as well.

In Cuba during slavery, the free people of color

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

created cabildos or houses to preserve their cultural and religious practices. So one would find for example a Lucumi/Yoruba cabildo, A Myombe Ba

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

Professional from academic institutions, pharmaceutical industries, health care indust

ntu Cabildo, An Arara Cabildo etc. The fact that many of the slaves were forced to practice Christianity enabled them to camouflage their religio

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

s practices under the guise of Christianity. This is where the misnomer of “Santeria” came into being; it was a blanket term for the Afro-Cuban R

.

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

eligions particularly of Lucumi origin. After slavery the whites still discouraged the practice of the African religions but the Cabildos kept th

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

Companies that provide selfless information through particip

Afro Cuban religions in tact. Despite all the attempts to under mind the African religions in Cuba, Afro-Cuban religions survived until this day

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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