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By now you should have observed that for every debit entry that is given to an account, or for every series of debits given to several accounts, there is a credit or a series of credits of an equ

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

al amount given to some other accounts and vice versa. It follows, therefore, that any time the debit balances standing in all the ledger accounts will equal to credit balances.

At the end of th

; 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 financial year (or at any other time) the balance (or totals) of all the ledger accounts arc extracted, and a schedule is prepared in journal form to test whether in fact, the total debits equa

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

the total credits. This schedule of balances is called a Trial Balance.

If the totals agree-what does it mean? It provides a reasonably reliable check and proves the arithmetical accuracy of th

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

e book-keeping entries.

If the totals do not agree-what does it mean? It shows that there is definitely something wrong b (some error) either in thy passing of the double entry or in the extract

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

Combination pro

ion of balances.

Definition of Trial Balance

According to Carter, "Trial Balance is the list of debit and credit balances, taken out from ledger, it also includes the balances

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

f cash and bank taken from cash book."

According to Pickles, "The statement prepared with the help of ledger balances, at the end of financial year (or at any other date) to find out whether deb

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

it total agrees with credit total is called Trial Balance".

According to Rowlland, "The final statement of balances, joint and mixed, is called Trial Balance".

Ideal definition, "On the basis o

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

f different definitions given by different accountants at different times, following ideal definition of trial balance can be adopted :

"According to double entry system, after recording all the

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

transactions into journal and posting them into ledger and ascertaining their balances, the statement prepared to ascertain the arithmetical accuracy of accounts on a certain date is called Trial

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

Balance. It is the statement, on the basis of which Trading, Profit and Loss Account and Balance Sheet is prepared".

On analyzing the above definition we obtain the following characteristics of

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

Following aspects would a

Trial Balance :-

(1) According to double entry system. after recording all transactions until all Ute business transactions are journalized, and posted, strictly according to double entry syste

dd to the challenges in developing combination products:

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

, a trial balance can't be extracted.

(2) After finding out the differences of debit and credit sides of all the ledger accounts :- All the accounts opened in ledger totaled and balances (differ

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

ences) are ascertained, only then trial balance can be prepared.

(3) Prepared on a particular date : Generally trial balance is prepared at the end of accounting year, but it can also be prepare

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

d monthly, half yearly or quarterly.

Preparation of Trial Balance

Trial Balance may be prepared either taking into consideration the total of each side of every ledger account.

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

Thus you may follow either "Total Method" or "Balance Method".

Total Method

If the total of debit sides of all the accounts in the ledger is placed in one column of the list an

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

Professional from academic institutions, pharmaceutical industries, health care indust

d similarly total of credit sides of all the accounts in the ledger is placed win another column of the list then this list of total (Trial Balance) will be known to have been prepared with the T

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

otal Methods.

Balance Method

Second method of preparing Trial Balance is to find out the difference of the ' sides of every account. If debit side of an account is bigger, than

.

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

insert the difference on the credit side of the account. It is known as 'debit balance'. If credit side of an account is bigger, then insert the difference on the debit side of the account. It is

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

Companies that provide selfless information through particip

known as 'credit balance'. Now prepare list of balances (Trial Balance) by putting all debits balances in one column and credit balances in another column. Such method is known as Balance Method

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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