Advice You - Finance

Companies and close corporations (CCs) must keep the following: records showing assets and liabilities; a register of fixed assets; records containing daily entries of all cash r

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

eceived and disbursed; records of all credit purchases or sales and services received or rendered on credit, in sufficient detail to identify the nature of the transactions and t

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

Examples of combination products may in

he parties concerned; statements of annual stock taking; records enabling the value of stock at the end of the year to be determined and vouchers supporting entries in the accoun

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

ting records.

A corporation must also keep records of members' contributions, un-drawn profits and revaluations of fixed assets and amounts of loans to and from members, in suff

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

icient detail to identify the nature and purpose of the individual transactions clearly.

These records must be kept in such a manner as to provide adequate precautions against f

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

Combination pro

alsification and to facilitate the discovery of any such falsification. A corporation that fails to keep such accounting records and every member who fails to take all reasonabl

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

e steps to prevent falsification is guilty of an offence. However, if the members entrusted the duty of keeping the accounting records or maintaining a system of internal contro

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

l to a 'competent and reliable person', this would be sufficient defence.

The financial year of a CC is its annual accounting period. A CC must specify the date of the end of i

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

ts financial year in its founding statement. As is the case with other information in the founding statement, the date of the end of the financial year may be changed by, regist

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

ering an amended founding statement.

The members of a corporation must, within a maximum of nine months after the end of every financial year, have financial statements prepared

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

The financial statements must be approved and signed by or on behalf of every member of the corporation and must consist of an accounting balance sheet and notes thereto and an

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

Following aspects would a

income statement or any similar financial statement, where such form is appropriate and any notes thereto.

The financial statements must disclose separately the aggregate amoun

dd to the challenges in developing combination products:

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

ts at the end of the accounting financial year and any changes in these amounts during the year of contributions by members, un-drawn profits, revaluations of fixed assets, amoun

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

ts of loans to members and amounts of loans from members.

The Close Corporation Act does not require a directors' report or an auditors' report and also does not contain a sched

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

ule, which lays down specific requirements for the preparation of annual financial accounting statements. The financial reports of a CC must, in conformity with Generally Accept

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

ed Accounting Practice (GAAP) appropriate to the business of the corporation, fairly present the state of affairs of the corporation at the end of the financial year concerned an

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

Professional from academic institutions, pharmaceutical industries, health care indust

d the result of its operations for the year.

In determining what constitutes generally acceptable accounting policy for the business of a particular corporation, the needs of th

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

e members and the primary users of the financial statements should be taken into account.

Over the years accounting practices in the various economic and industrial environments

.

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

have developed in such a manner as to record and fairly present transactions and occurrences specific to these environments. In deciding what is 'suitable for the business', co

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

Companies that provide selfless information through particip

nsideration should also be given to the commercial and management activities of the corporation and the accepted accounting practice in the working environment of the corporation

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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