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Actual - Need to Provide Level Playing Field
There is growing unrest among the dealers and employees working in the retail outlets of private oil companies as their jobs and investments are under thr
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
eat due to discriminatory policies of the Government which are heavily loaded in favour of public sector undertakings. The threat is affecting nearly 6500
; 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
people employed in the sector and large number of dealers who had invested Rs. 1.5 - 2.0 crores each in these outlets.
These outlets were set up after t
These outlets were set up after 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 Government of India notified a new policy for deregulation and marketing of petroleum products at the market driven prices. This announcement on 1st Apr
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
l, 2002 declared that the consumer prices of motor spirit and high speed diesel will be market determined with effect from that date. Consequent to this 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
licy rights were granted to private players which made heavy investments in order to sell these products at market prices.
But contrary to this policy si
But contrary to this policy si
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
ce mid 2004 the Government began to intervene and prevent PSU marketing companies from increasing domestic prices as a result of hike in international pri
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
es. The Government also compensated PSU marketing companies through budgetary support in terms of oil bonds and discount given by upstream players like ON
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
C. This non transparent process compensated PSUs for about 1/3 of their under recoveries on Motor Spirit and High Speed Diesel in 2005-06 (Rs. 5931 crores
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
out of Rs. 14964 crores) and fully in 2006 – 2007 (est. Rs. 20500 crores).
This private companies were left with no choice but to either absorb huge loss
This private companies were left with no choice but to either absorb huge loss
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
s by continuing to sell MS and HSD at same price as public sector undertakings or reduce volumes through price increase. Any attempt to sell products at p
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
ices higher than PSU oil companies resulted in no sale. The consumers are also suffering because they are forced to buy from PSUs outlets only. This is al
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
o increasing the subsidy burden on the Government as PSUs have to sell larger volumes.
The only solution of the problem lies in scrapping subsidies and t
The only solution of the problem lies in scrapping subsidies and t
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
xes that co-exist along with subsidized LPG and PDS Kerosene. This virtually eliminates the possibilities of participation by private sector. One time red
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
ction in Excise duty can enable Government of India to eliminate subsidies in all forms and also help in reviving private sector and assure in better cust
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
mer service through competition.
The impact of any subsequent increase in International prices can be countered by reducing Excise duty by Rs. 300/KL on
The impact of any subsequent increase in International prices can be countered by reducing Excise duty by Rs. 300/KL on
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
SD and Rs. 420/KL on MS for every dollar per barrel increase in international prices or alternatively in steps of Re 1/litre for both MS and HSD for every
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
3 USD/Bbl increase in International prices.
The other option is to pay subsidy to the private companies also as done in the case of PSU marketing compani
The other option is to pay subsidy to the private companies also as done in the case of PSU marketing compani
.
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
s. Another alternative is to have fix subsidy per litre which can be adjusted by oil marketing companies in both the sectors on duty payments based on Exc
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
se paid with gate passes for removal of products from refineries for domestic consumption. This is the pattern followed in the case of Fertilizer Industry
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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