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Main Subject - Basic Bookkeeping
J. R. Baltiboi has observed that Bookkeeping is the art of recording business dea
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
lings in a set of books. Bookkeeping is the science and art of systematically rec
; 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
ording, classifying and summarizing the financial transactions or events of a bus
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
iness in a set of books. A business transaction means the exchange of money or it
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ems of value between two or more persons. Anytime this occurs, bookkeeping comes
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
into play.
It has been noted that the process of accounting begins as the busine
It has been noted that the process of accounting begins as the busine
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
ss transaction occurs. Once a business transaction takes place it is recorded in
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
the books of accounts. This process starts with recording transactions in the pri
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
mary-entry cash book, bank book, sales book, purchase book, debit note/credit not
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
ebook and journal. These are regarded as the books of primary entry where transa
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ctions are first recorded.
Transactions are then posted to the ledger account. T
Transactions are then posted to the ledger account. T
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
his is called the ledger posting. The balancing of each ledger account is done at
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
periodic intervals which cannot be longer than one year. Many organizations do i
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
t on a monthly, quarterly or half-yearly basis.
The trial balance is prepared fr
The trial balance is prepared fr
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
om the ledger balances. In this statement, the totals of debits and credits must
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
agree with each other. This is the test of arithmetical accuracy of recording, po
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
sting and totaling. The debits and credits must tally.
Many necessary adjustment
Many necessary adjustment
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
s and provisions are made to ensure that accounting is done in conformity with th
.
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
e Generally Accepted Accounting Principles (G A A P). These rules and regulations
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
are universally adopted by the accountants in recording accounting transactions.
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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