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  • Advice You - Definition and Objectives of Bookkeeping and Accounting Systems

    Accounting is defined as "the art of recording, classifying and summarizing in terms of money transactions and events of financial character and interpreting the results thereof." In simplest words, we can say:

    (1) Accounting is an art


    (2) of recording classifying and summarizing


    (3) in terms of money


    (4) transactions
    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
    and events of financial nature and


    (5) interpreting the results thereof


    Accounting is an art of correctly recording the day to day business transactions: It is a science of keeping the business records in a regular and most systematic manner so as to know the business results with minimum trouble. Therefore, it is said 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
    e a statistical procedure for the collection, classification and summarization of financial information.


    Objectives of Accounting


    The objectives of accounting are two-fold:


    (1) To record permanently, all business transactions, and


    (2) To show the effect of each transaction and also the combined ef
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    fect of all such transactions for a given period so as to find out the profit the business has earned or loss incurred, and also to know the correct financial position on a particular date.

    The necessity and importance of accounting can be understood by answering the following questions:


    (1) How much we have earned this year ?<
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    r>

    (2) How much was earned during the last year ?


    (3) Is our business improving?


    (4) How much cash do we have?


    (5) How much money we owe?


    (6) How much others owe to us ?


    Accounting Systems


    There are various systems of accounting for maintaining business records:


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

    Combination pro
    of accounting


    This system records only cash receipts and payments on the assumption that there are no credit transactions. If at all there are any credit transactions, they are not at all recorded until the cash is actually paid or received. Receipts and payments account in case of clubs, societies, hospital, educationa
    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
    l institutes, lawyers etc. is the best example of cash system.


    Single Entry System


    This system ignores the two fold aspect of each transaction as considered in double entry system. Under single entry system, merely personal aspects of transaction i.e. personal accounts are recorded. This method takes no not
    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
    of the impersonal aspects of the transactions other than cash. It offers no check on the accuracy of the posting and no safeguard against fraud because it does not provide any check over the recording of cash transactions. Therefore, it is called as "imperfect accounting."


    Double Entry System


    The double en
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ry system was first evolved by Luca Pacioliin, who was a Franciscan Monk of Italy. With the passage of time, the system has gone through lot of developmental stages. It is the only method fulfilling all the objectives of systematic accounting. It recognizes the two fold aspect of every business transaction.

    These questions are of de
    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
    cisive importance for a trader and the answers can only be derived from up to-date financial records. Only the system of keeping the perfect records of all business transactions will help the proprietor to know the amount he has gained or lost.

    The main objective of any business is to earn maximum possible profits with minimum expen
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    e. In view of this, a commercial organization always tries to expand its business, increase its sales and reduce operating expenses. The progress made in this regard, is always indicated only by the properly maintained financial records.

    Meaning of Accounting

    In the beginning, the main objective of accounting was t
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ascertain the result of the business activities (whether profit has been earned or loss has been suffered) during a year and to show the financial position of the business as on a particular date. Accounting has to meet the requirements of taxation authorities; investors, government regulations; management and owners. This has resul
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ted in widening the scope of accounting and may be defined as follows:

    "Accounting is the art of recording, classifying and summarizing, in a significant manner and in terms of money transactions and events which are in part at least, of a financial character and interpreting the result thereof."

    Is Accounting a Science or
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    n Art?

    In simple words, science establishes relationship of cause and effect whereas the art is the application of knowledge comprising of some accepted theories, principles and rules. Since accounting docs not establish cause and effect relationship it only provides us with the procedure by which objectives of accounting c
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    n be achieved, therefore accounting is an art and not a science. Accounting is an art of recording financial transactions in a set of books; classifying in desired categories and summarizing the information for presentation in a suitable manner to the concerned persons for their benefit.

    Scope of Accounting

    The nee
    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
    d of a system of accounting was felt by man early in the history of trade and commerce. The art of book-keeping is as old as the art of trading itself. This art of keeping records passed through many phases since its inception. With the development of commerce, it has attained a position of great importance. Indeed, it can be truly s
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    id that accounting has become the foundation on which the whole fabric of modem commerce rests.

    Though there is no legal obligation on an ordinary trader to keep the records, every business house finds it essential and convenient to keep the systematic records so as to know where exactly it stands. Moreover, it is legally binding on
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    some forms of business, such as joint stock companies, to prepare periodically, statements in proper forms showing the position of the business. A proper and satisfactory method of accounting is an essential part of any business house for the following reasons :

    (1) If no records are kept, it will be difficult to find out accurate n
    .

    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
    et profit. Under such circumstances, tax authorities may overestimate the profits and thus a trader will suffer for not having kept the business records.


    (2) In absence of proper business records, the trader will find it difficult to submit the true position to the court in case he becomes insolvent.


    (3) Keeping of proper r
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    cords helps the trader in framing future business plans & policies.


    (4) It will be difficult to ascertain and fix the price of business to be sold or disposed off, if no records are kept.


    (5) Finally, in spite of the best memory it is beyond the capacity of a trader to remember all the business dealings with back references


    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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