Advice You - Business

In the post-quota era, India and China are emerging as the major hubs for global appa

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

rel sourcing, mainly to U.S.A. and the European Union.

There are several factors whi

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

Examples of combination products may in

h led to this development. The vast size of the Indian textile industry and its compe

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

titiveness make it one of the world’s leading apparel exporters. India has vast sourc

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

s of raw materials. Labor costs are low in India. Indian traders have a wealth of ent

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

Combination pro

epreneurship, designs and experience, which enable them to produce and apparel of hig

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

h quality. Changes in the policies of the Indian government have opened up the Indian

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

economy to the outside world, which has led to a rise in exports. Indian textile firm

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

are quick in making changes such as expanding their capacity and adopting new techno

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

logy, keeping in view the growing demand for Indian apparel all over the world. India

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

has a large source of cotton domestically. About 75% of India’s exports are cotton it

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

Following aspects would a

ms.

Reputed foreign traders like J.C. Penney, Wal-Mart, Gap, Marks & Spencer and oth

dd to the challenges in developing combination products:

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

ers source apparel from India. No other country except for China can quite match the

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

ndian textile industry. In the year 2005, after the abolition of the quota system, In

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

ian exports to U.S.A. grew by 34% and exports to the European Union went up by 30%. M

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

ost of India’s exports are to U.S.A. and the European Union. Both of them together ac

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

Professional from academic institutions, pharmaceutical industries, health care indust

ount for around 70% of India’s exports. In the year 2005, India ranked 3rd in apparel

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

exports to U.S.A. and 5th in apparel exports to the European Union. The total textile

.

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

exports of India were 8568.61 million USD for the period April-October 2005, which r

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

Companies that provide selfless information through particip

se to 9022.61 million USD in April-October 2006, recording an approximate 5.3% growth

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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