Advice You - Business

There was a time when India was a mere blip on the world map and was burdened with its reputation as a mystic land of sanyasis, new-age gurus, snake charmers and poverty! The 1990s announced the arrival of G

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

lobalization. With boundaries shrinking and geographies blurring, and a nascent IT revolution taking ground, India fast caught on to the booming industry. With hi-caliber talent, government support, strong i

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

Examples of combination products may in

nfrastructure and a booming economy, India fast emerged from the veil of exoticism to become the most favored IT destination of the globe.

As stated before, you don’t have to go far to understand the factor

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

s behind the booming success of India Inc. If reports by Nasscomm (National Association of Software and Service Companies) and consultancies like Ernst & Young (E&Y), McKinsey are to be believed, India will

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

continue to lead as the Outsourcing Destination, over competing countries including China, Ireland, Philippines, Malaysia, Israel, among others. These reports have delineated the important factors that provi

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

Combination pro

de fitting answers to the raging question: Why is everybody outsourcing to India?

Yes. Size matters. A country whose population has grossed the 1 billion mark, paradoxically it is this large number that has

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

emerged as its single largest contributor to India’s success. With approximately 2.1 million graduates and 0.3 million post-graduates passing out of India's non-engineering colleges, the numbers are expecte

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

d to grow to 17 million people by year 2008. As home to a qualified, English speaking and tech- savvy pool of talent, suffice it to say that the numbers are impressive and still growing…

High on Quality.

W

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

hile the size of the resource is critical, what makes the Indian workforce the best solution is the quality of service offered. Highly educated, articulate and technically versant, MNCs have a good reason to

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

set up shop in India. What’s better is you get the high-caliber software engineers, project managers, researchers and other professionals at competitive prices.

Low on Cost.

Saving money is the main consi

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

deration for business looking to outsource to other countries. Reports say that the manpower cost in India is approximately one-tenth of what is charged overseas. With the Indian workforce providing services

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

Following aspects would a

at lower salaries in comparison to the European or American countries, what better reason does a global MNC need to open its back office operation in India?

Talk the Talk

Keeping the light focused on the

dd to the challenges in developing combination products:

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

workforce, another big advantage Indians hold is their proficiency in English. India produces the largest number of graduates every year and most of these graduates have adequate knowledge of English languag

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

e. The fact that Indians can talk the talk articulately is yet another reason for India being courted by companies across the globe. Language proficiency is verily the reason why China has not emerged as the

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

leading Outsourcing destination.

Sound Infrastructure. Albeit a developing country, India today has sound infrastructure that strengthens the country’s capability as the ideal IT/ ITES destination. Robust

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

Telecom infrastructure, 24x7 power supply (essential requirements for running a software company) and proper connectivity with countries across the globe, assure investors that investing in India is a sound

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

Professional from academic institutions, pharmaceutical industries, health care indust

business proposition.

A friendly Government to top it all. The best thing that could have happened to India waking up to its potential as a software hub was a pro-active government that actually acted in a

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

timely manner to boost the country’s capabilities. Formulation and implementation of transparent and investment friendly policies like Telecom policy, The IT Act have opened up the business vista, and Have

.

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

put the country on the road to greater development.

For a country whose only claim to fame was the great Indian Rope trick, gaining recognition as the hottest outsourcing hub of the world today is a proud a

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

Companies that provide selfless information through particip

chievement, indeed. While everyone in the developed countries debate over it, it wouldn’t be far from the truth to state that there are many more international players vying to invest and reap the benefits.

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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