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1.INDENTS(purchase order indent form ) : First step for any purchase activity is a clear

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

indent from the user departments . The indent should have authorised signatory .Its shoul

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

Examples of combination products may in

clearly mention the quantity,delivery time and specifications .

2.QUOTATION : Purchase

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

executive then floats inquiry as per the details given in the indents.it could be given t

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

one vendor or to any numbers as stipulated in their organisations standards , the best p

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

Combination pro

ractices is to get one alternate source . In case of emergency or in vendors reluctance t

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

send quotation telephonic or verbal inquiry could be floated . The inquiries are sent wi

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

th clear instruction to vendors for response with in stipulated time .Vendors then submit

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

their quotation to the purchase department.

3. BID SHEET OR COMPARISON SHEET :Comparison

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

is then made for the best vendors taking into account various factors such as

a. Price

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

b. Quality

c. Delivery time

d. Payment terms

e. Warranty

f. After Sales Service.

4.

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

Following aspects would a

EGOTIATIONS : Then Vendors are called for negotiations & further clarification and fi

dd to the challenges in developing combination products:

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

nalisation of terms and condition of contracts.

5.PURCHASE ORDER : Purchase orders are t

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

en generated for the agreed upon terms and conditions .Purchase order are then either fax

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

ed or couriered to the suppliers with clear terms and conditions .

AMENDMENT : There is

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

provision to amend purchase order for terms and conditions due to some unforeseen circum

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

Professional from academic institutions, pharmaceutical industries, health care indust

stances which are beyond vendors control .

6. FOLLOW UP : After orders are faxed the pur

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

hase executive monitors orders for delivery .

7.VENDOR DEVELOPMENT :Most important part

.

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

of any purchase executive is to upgrade vendor master with new vendors which are selected

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

Companies that provide selfless information through particip

for reasons like alternate supplier for critical items or under cost reduction strategies

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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