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Useful Advices - Indian Pharmaceutical Companies
Storm clouds are hovering in the drug research domain where Indian companies have raked in th
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 moolah from a string of successful discoveries.
Research costs are on the rise and the cha
Research costs are on the rise and the cha
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
nces of success in discoveries are less.
The time to develop new drugs has also lengthened.
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
A few years ago, it took around two years to launch a new drug; it now takes over six after
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
approvals and clinical trials.
According to Paresh Vaish, director of the Boston Consulting
According to Paresh Vaish, director of the Boston Consulting
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
Group, the cost of research is rising. The cost would be $2.3 billion in 2010 from $1.5 bil
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
lion now, he said.
Vaish, who analyses drug trends, said a company launched only one drug fr
Vaish, who analyses drug trends, said a company launched only one drug fr
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
om a pipeline of eight molecules between 1995 and 2000. It is one from 13 molecules now.
Li
Li
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ke the global majors, In-3ian pharmaceutical companies are spending big on research, with s
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
ome even investing around 10 per cent of their top line.
Dr Reddy's Laboratories, Ranbaxy L
Dr Reddy's Laboratories, Ranbaxy L
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
aboratories, Sun Pharma, Lupin and many others are trying to build a pipeline of new chemica
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
l entities (NCEs). Ranbaxy's NCE pipeline has 3-5 molecules in the late discovery stage and
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
two in the second phrase;of clinical trials. Dr Reddy's has nine molecules in various stages
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
of development.
At the annual general meeting of the Organisation of Pharmaceutical Producer
At the annual general meeting of the Organisation of Pharmaceutical Producer
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
s of India (OPPI), Vaish said the industry's growth and profits have been driven by prices in
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
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
the US. He said the drug prices in the US are the highest in the world, while in Canada the
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
prices are half of that in the US.
Vaish warned that prices in the US could fall by 20 per c
Vaish warned that prices in the US could fall by 20 per c
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ent as the US government would step up purchases for its medical health insurance programme.
.
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
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
The government incentives for research must be extended by another 10 years, OPPI presiden
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
t Ranjit Sha-hani said today at the meeting. The incentives will come to an end in March 2007
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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