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Suggest - GSLV and the future of India's Space Program
The Geosynchronous Satellite Launch Vehicle (GSLV) is India's largest launch v
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
ehicle, intended to eventually launch INSAT type communication satellites, to
; 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
ake India less dependent on foreign rockets for INSAT launches, Till now all t
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
e INSATs have been launched using foreign launch facilities at exorbitant cost
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
. Once GSLV become operational, India will have total control over its INSAT p
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ogram.
The GSLV is a three stage rocket, the first stage of which uses solid
The GSLV is a three stage rocket, the first stage of which uses solid
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
ropellant motor and second stage uses a liquid propellant motor. It also uses
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
our liquid strap on boosters and cryogenic third stage. The solid first and li
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
uid second stages of GSLV are carried over from the PSLV.
The GSLV is designe
The GSLV is designe
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
to place a payload of approximately 500 kg in to an easterly low earth orbit,
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
or a 2200 kg pay load, into a geosynchronous transfer. Three development fligh
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
s of GSLV have already taken place. Once operational, all INSATs in future are
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
to be launched from India soil using the GSLV.
The cryogenic engine is a cruc
The cryogenic engine is a cruc
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
al component of GSLV. It uses liquid Oxygen and liquid hydrogen stored at very
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
low temperature as propellants and produces the maximum thrust per unit weight
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
Without a cryogenic upper stage, it would be impossible to place a 2500 kg sa
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
ellite in to GTO. The GSLV will initially use cryogenic upper stage engine sup
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
lied by Russia, but subsequently, indigenously developed cryogenic engines wil
.
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
be used. ISRO has already designed and built a full scale cryogenic engine fo
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
use in the GSLV and tests on indigenous cryogenic engine have been successful
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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