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How good was the Budget-2007 presented yesterday by Mr. P Chidambaram? This was the question that was running all over the place yesterday. The final verdict came down to a great Thumbs Down to the Finance Minister. The main reason for these thumbs down from the middl

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

e class is the fact that there was no tax exemption method added. The media is more concerned with the lack of Reforms and the slight increase in Taxation on the BPO and IT industry.

This puts in effect the core question about Budget – Any budget which does not decre

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

Examples of combination products may in

se my Tax Burden is a bad budget? The majority answer seems to be a rousing YES to this question. I have some conversation (maybe you can call it as debates) with my friends about this. In my opinion any Budget which does not drastically increase my Tax Burden is a “G

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

od Average Budget”. My friends and majority of the public in India seems to disagree strongly with this. One of the points raised against paying the taxes is the lack of facility provided by the Government for the ordinary Man. Another point which is more constantly 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

aised is the corruption in the system, because of which the end user (the poor of this country) does not get benefited by the all measures that are announced in Budget. Yesterday I was watching a program in CNBC-TV18; there also the earlier mentioned two points came i

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

Combination pro

to discussion. I have to say I was very much satisfied by the answer given by the FICCI chairman in the second concern’s context. The bottom line is that we cannot stop spending because our delivery system is corrupt to the core; moreover it’s not the Finance Minister

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

s job to tackle corruption especially in Budget. There is no doubt that the corruption in this country is reaching alarming proportion, is the Government the only person to be blamed? No absolutely not. Every one of us has to be blamed for this. Why we always take the

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

option of bribing officials to get our things done. Why can’t we follow the more honest path?

Everyone points to Japan and West to shows how things have to be done. The major difference between people in those countries to us is the attitude of the people. Indian me

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

ia has an addiction to the word Reforms and yesterday they especially CNBC were more concerned with that. Even one of their reporters raised this question to the Finance Minister. His answer was more from a Man who was rightly irritated. The point he raised where “Why

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

the main stream Media not consider anything done in Agriculture and Public Health department as a part of Reforms? Why only the things that are concerned with the Corporate World qualify under the word Reforms?” These questions were absolutely right but were addressed

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

at the wrong media. Today’s Media belongs to the corporate world and they report the events from their own perspective, not from an ideal perspective. Major concerns were raised about the FM’s inability to include public Health and Education in the so called Reform pl

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

Following aspects would a

atter. Public Health department provide the cheapest means of health care for a wide variety of people in this country. Most of those hospitals are having minimum facility or no facility and the Budget should have tackled that. Bring private participation to Health ma

dd to the challenges in developing combination products:

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

solve the facility problem but then those hospitals will become mostly unaffordable to the large lower class public.

One major concern before the budget was presented was the rate of inflation. In the budget the tax on diesel was decreased to tackle this. But believ

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

me this is not going to make any change. Inflation is driven by the disparity of the goods available to the goods consumed. Inflation does not go up overnight and it does not come down overnight. Like cancer the only way out of Inflation going up, is detecting it ear

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

lier. This government is a total failure in identifying the factors which drives the inflation and tackling it. So unless we increase our agricultural products drastically inflation may go up (the only short term method is import essential goods). Last budget FM talke

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

about another Green Revolution in agriculture. But no concrete steps were taken for that.

The corporate houses of the country will have to pay more taxes by the inclusion of ESOPs in FBT and MAT. One of my friends raised a fear that this will cause the corporate hou

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

Professional from academic institutions, pharmaceutical industries, health care indust

es to shift the operation from India to China. If the corporate houses behave like that then serious doubt has to be raised about their commitment to country’s growth ahead. Corporate Houses in this country are enjoying serious tax exemption and its time for them to c

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

ontribute a little further for development of country. Creating jobs are the by product of their growth as we have that many resources (technically qualified persons). I don’t think Corporate Houses in this country will migrate for this silly reason, but in 5-10 years

.

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

time we can see heavy migration to China. This will not be because of tax exemption but because of the vast local Chinese hardware industry. In 5-10 years time the Global service industry will be catering more to the needs of the Local Chinese industry.

All in all, t

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

Companies that provide selfless information through particip

is budget was not a breakthrough budget, but it was not that bad either. Many of you people will not agree with what I have written above. You may be thinking why this stupid is wasting so much precious blog space. Then in a democracy, even idiots like me have a voice

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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