PHARMA_CARR_874E.pdf

8/10/2019 PHARMA_CARR_874E.pdf

1/28

1

[TOBEPUBLISHEDINTHEGAZETTEOFINDIA,EXTRAORDINARY,PARTII,

SECTION3,SUBSECTION(i)]

MINISTRYOFCORPORATEAFFAIRS

Notification

NewDelhidatedthe7th,

Dec,2011

G.S.R.874 (E). Inexerciseof thepowersconferredby subsection (1)of section642,

readwithclause (d)ofsubsection (1)ofsection209oftheCompaniesAct,1956 (1of

1956),andinsupersessionoftheCostAccountingRecords(BulkDrugs)Rules,1974vide

G.S.R.130(E),dated the14th

March, 1974andCostAccounting Records (Formulations)

Rules,1988videG.S.R.452,datedthe22nd

April,1988,exceptasrespectsthingsdoneor

omittedtobedonebeforesuchsupersession,theCentralGovernmentherebymakesthe

followingrules,namely:

1.ShortTitleandCommencement,(1)TheserulesmaybecalledtheCostAccounting

Records(PharmaceuticalIndustry)Rules,2011.

(2)TheyshallcomeintoforceonthedateoftheirpublicationintheOfficialGazette.

2. DefinitionsandInterpretations,Intheserules,unlessotherwiserequires,

(a)

ActmeanstheCompaniesAct,1956(1of1956);

(b) bulkdrugs"meansanypharmaceutical,chemical,biologicalorplantproduct

including its salts, esters, stereoisomers and derivatives, which are used as

suchor

as

an

ingredient

in

any

formulation

and

shall

include

any

bulk

drug

included inanybonafideAllopathic,Ayurvedic,Homeopathic,SidhaorUnani

(Tibb)systemsofmedicine;

(c)

compliance report means the compliance report duly authenticated and

signedbyacostaccountantinthespecifiedformofcompliancereport;

(d)

CostAccountantforthepurposeoftheserulesmeansacostaccountantas

defined in clause (b) of subsection (1) of section 2 of the Cost and Works

AccountantsAct,1959(23of1959)andwho iseitherapermanentemployee

ofthecompanyorholdsavalidcertificateofpracticeundersubsection(1)of

section6and

who

is

deemed

to

be

in

practice

under

sub

section

(2)

of

section

2ofthatActandincludesafirmofcostaccountants;

(e)

CostAccountingStandardsmeans thestandardsofcostaccounting, issued

bytheInstitute;

(f)

cost records means books of account relating to utilisation of materials,

labour and other items of cost as applicable to the production, processing,

manufacturingorminingactivitiesofthecompany;


2/28

2

(g)

FormAmeanstheformspecified intheserulesforfilingcompliancereport

andotherdocumentswiththeCentralGovernmentintheelectronicmode;

(h) FormBmeanstheformofthecompliancereportandincludesAnnexureto

thecompliancereport;

(i)

"formulations"means

any

medicine

processed

out

of

or

containing

one

or

more bulk drugs with or without the use of any pharmaceutical aids for

internal or external use for or in the diagnosis, treatment, mitigation or

prevention of disease in human beings or animals and shall include any

medicineincluded inanybonafideAllopathic,Ayurvedic,Homeopathic,Sidha

orUnani(Tibb)systemsofmedicine;

(j)

GenerallyAcceptedCostAccountingPrinciplesmeanstheprinciplesofcost

accountingissuedbytheInstitute;

(k)

Institute means the Institute of Cost and Works Accountants of India

constitutedunder

the

Cost

and

Works

Accountants

Act,

1959

(23

of

1959);

(l)

pharmaceuticalactivitiesmeansproduction,processing,ormanufacturingof

bulkdrugsorformulationsand includesthemeaningassignedtothemunder

the Drugs (Prices Control) Order 1995 as amended from time to time, or

includedunderChapters29and30oftheCentralExciseTariffAct,1985(5of

1986), and further includes the intermediate products and articles or allied

productsthereof;

(m)productmeansanytangibleor intangiblegood,material,substance,article,

idea,knowhow,method,information,object,service,etc.thatistheresultof

human,

mechanical,

industrial,

chemical,

or

natural

act,

process,

procedure,

function, operation, technique, or treatment and is intended for use,

consumption,sale,transport,store,deliveryordisposal;

(n)

product group in relation to tangible products means a group of

homogenous and alike products, produced from same raw materials and by

usingsimilaror sameproductionprocess,havingsimilarphysicalorchemical

characteristicsandcommonunitofmeasurement,andhavingsameorsimilar

usageorapplication;and inrelationto intangibleproductsmeansagroupof

homogenousandalikeproductsorservices,producedbyusingsimilarorsame

process or inputs, having similar characteristics and common unit of

measurement,

and

having

same

or

similar

usage

or

application;

(o)

turnovermeanstotalturnovermadebythecompanyfromthesaleorsupply

ofallproductsorservicesduringthefinancialyearanditincludesanyturnover

from job work or loan license operations and the subsidies or grants or

incentivesreceivedbutdoesnotincludeanynonoperationalincome;

(p)

all other words and expressions used in these rules but not defined, and

definedintheActandrulesmadeunderclause(d)ofsubsection(1)ofsection


3/28

3

209oftheActshallhavethesamemeaningsasassignedtothemintheActor

rules,asthecasemaybe.

3. Application,Theserulesshallapplytoeverycompany,includingaforeigncompany

as defined under section 591 of the Act, which is engaged in the production,

processing,ormanufacturingofpharmaceuticalactivitiesandwherein,theaggregate

valueof

net

worth

as

on

the

last

date

of

the

immediately

preceding

financial

year

exceedsfivecroresofrupees;orwhereintheaggregatevalueoftheturnovermade

by the company from sale or supply of all products or activities during the

immediately preceding financial year exceeds twenty crores of rupees; or wherein

thecompanysequityordebtsecuritiesare listedorare intheprocessof listingon

anystockexchange,whetherinIndiaoroutsideIndia:

Providedthattheserulesshallnotapplytoabodycorporategovernedbyany

specialAct.

4. Maintenanceofrecords,(1)Everycompanytowhichtheserulesapply,includingall

unitsand

branches

thereof

shall,

in

respect

of

each

of

its

financial

year

commencing

onorafterthedateofthisnotification,keepcostrecordsandthebooksofaccount

somaintained shallcontain, interalia, the particulars specified in ProformaeA to I

mentionedintheScheduleannexedtotheserules.

(2)

Thecost records referredto insubrule (1)shallbekeptonregularbasis in

suchmannersoastomakeitpossibletocalculateperunitcostofproduction

or cost of operations,costof sales and margin for each of its products and

activities for every financial year on monthly or quarterly or halfyearly or

annualbasis.

(3)

The

cost

records

shall

be

maintained

in

accordance

with

the

generallyacceptedcostaccountingprinciplesandcostaccountingstandards issuedby

theInstitute;totheextentthesearefoundtoberelevantandapplicableand

thevariations,ifany,shallbeclearlyindicatedandexplained.

(4) The cost records shall be maintained in such manner so as to enable the

company toexercise,as faras possible,controlover the various operations

and costs with a view to achieve optimum economies in utilization of

resources and these records shall also provide necessary data which is

requiredtobefurnishedundertheserules.

(5)

All

such

cost

records

and

cost

statements,

maintained

under

these

rules

shall

be reconciled with the audited financial statements for the financial year

specificallyindicatingexpensesorincomesnotconsideredinthecostrecords

or statements so as to ensure accuracy and to reconcile the profit of all

productgroupswith theoverallprofitof thecompanyand thevariations, if

any,shallbeclearlyindicatedandexplained.


4/28

4

(6) All such cost records, cost statements and reconciliation statements,

maintained under these rules, relating to a period of not less than eight

financialyearsimmediatelyprecedingafinancialyearorwherethecompany

hadbeen inexistenceforaperiod lessthaneightyears, inrespectofallthe

precedingyearsshallbekeptingoodorder.

(7)

Every person, referred to in subsection (6) and (7) of section 209 of the

Companies Act, 1956 (1 of 1956), shall take all reasonable steps to secure

compliance by the company with the provisions of these rules in the same

mannerasheisliabletomaintainaccountsrequiredundersubsection(1)of

section209ofthesaidAct.

5. Formof theComplianceReport,Everycompany towhich these rulesapplyshall

submitacompliancereport,inrespectofeachofitsfinancialyearcommencingonor

afterthedateofthisnotification,dulycertifiedbyaCostAccountant,alongwiththe

AnnexuretotheCentralGovernment,inthespecifiedform.

6.

Timelimit

for

submission

of

Compliance

Report,

Every

company

shall

submit

the

compliancereportreferredtoinrule5totheCentralGovernmentwithinaperiodof

onehundredandeightydaysfromthecloseofthecompanysfinancialyeartowhich

thecompliancereportrelates.

7. Authentication of Annexure to the Compliance Report, The Annexure to the

compliancereportshallbeapprovedbytheBoardofDirectorsandcertifiedby the

Cost Accountant before submitting the same to the Central Government by the

company.

8.

Penalties, (1) If default is made by the Cost Accountant in complying with the

provisionsof

these

rules,

he

shall

be

punishable

with

fine,

which

may

extend

to

five

thousandrupees.

(2)

Forcontraventionoftheserules,

(a)

the company shall be punishable as provided under subsection (2) of

section642oftheAct;and

(b)everyofficerthereofwhoisindefault,includingthepersonsreferredtoin

subsection(6)ofsection209oftheAct,shallbepunishableasprovided

undersubsections(5)and(7)ofsection209ofCompaniesAct,1956(1of

1956).

9. Savings,ThesupersessionoftheCostAccountingRecords(BulkDrugs)Rules,1974

andCostAccountingRecords(Formulations)Rules,1988,shallnotinanywayaffect

(a)any right, obligation or liabilities acquired, accrued or incurred

thereunder;


5/28

5

(b)

any penalty, forfeiture or punishment incurred in respect of any

contraventioncommittedthereunder;and

(c) anyinvestigation,legalproceedingorremedyinrespectofanysuchright,

privilege, obligation, liability, penalty, forfeiture or punishment as

aforesaid,and;anysuchinvestigation,legalproceedingorremedymaybe

instituted,

continued

or

enforced

and

any

such

penalty,

forfeiture

or

punishmentmaybeimposedasifthoseruleshadnotbeensuperseded.


6/28

6

FORMA FormforfilingComplianceReportandotherdocumentswiththeCentralGovernment

[Pursuanttosection209(1)(d),600(3)(b)oftheCompaniesAct,1956andrule2oftheCostAccounting

Records(PharmaceuticalIndustry)Rules,2011]

PARTIGENERAL

INFORMATION

Note:Allfieldsmarkedin*aretobemandatorilyfilled.

1 (a) *Corporateidentitynumber(CIN)or

foreigncompanyregistrationnumberof

thecompany

PreFill

(b) Globallocationnumber(GLN)of

company

2

(a)

*Nameof

the

company

(b) *Addressoftheregisteredofficeorof

theprincipalplaceofbusinessinIndia

ofthecompany

(c) *EmailAddressofthecompany

3 (a) *Financialyearcoveredbythe

compliancereportFrom (DD/MM/YYYY)

To (DD/MM/YYYY)

(b) *DateofBoardofdirectorsmeetinginwhichannexure

tothecompliancereportwasapproved(DD/MM/YYYY)

4.Detailsofthecostaccountant

(a) *CategoryofthecostaccountantIndividual Costaccountants

firm

(b) Incaseofindividual,whetherthecostaccountant

isinpermanentemploymentofthecompanyorin

practice

InEmployment InPractice

(c) *Nameofthecostaccountantorthe

costaccountantsfirmwhohascertified

thecostrecordsofthecompany

(d) *Incometaxpermanentaccountnumberofthecostaccountantorthecost

accountantsfirm


7/28

7

(e) *Membershipnumberofcostaccountantorcostaccountantsfirms

registrationnumber

(f) Addressofthecostaccountantorcostaccountantsfirm

(i) LineI

LineII

(ii)City

(iii)State

(iv)Country

(v) PinCode

(g) *EmailIDofthecostaccountantor

costaccountantsfirm

5.*QuantitativeInformation

NetSalesSno. NameoftheProductorServiceGroup Unit Annual

Production

(Quantity)

(Quantity) (Valuein

Rupees)

A ProducedorManufacturedProduct

1.

2.

3.etc.

B ServicesGroups

1.

2.

3.etc.

C

TradingActivities

(Product

Group

wise)

1.

2.

3.etc.

D OtherIncome

TotalIncomeasperFinancialAccounts

PARTII

Attachments:

1

CompliancereportaspertheCostAccounting

Records(PharmaceuticalIndustry)

Rules,

2011

Attach

2 Optionalattachments(s)ifany Attach

Listofattachments


8/28

8

Removeattachment

Verification:

Tothebestofmyknowledgeandbelief,theinformationgiveninthisformanditsattachmentsiscorrect

andcomplete.

IhavebeenauthorisedbytheBoardofdirectors

resolutionnumber

dated

(DD/MM/YYYY)

tosignandsubmitthisform.

Iamauthorisedtosignandsubmitthisform.

Tobedigitallysignedby:

ManagingDirectorordirectorormanagerorsecretary(incaseofanIndiancompany)

oranauthorisedrepresentative(incaseofaforeign

company)

Digital

Signatures

*Designation

*Directoridentification

number

of

the

director

or

Managing

Director;

or

Income

tax

PAN

ofthemanagerorofauthorisedrepresentative;orMembershipnumber,ifapplicableor

incometaxPANofthesecretary(secretaryofacompanywhoisnotamemberofICSI

mayquotehis/herincometaxPAN)

DirectorofthecompanyDigital

Signatures

Directoridentificationnumberofthedirector

Modify

CheckForm

Pre

scrutiny

Submit

ThiseformhasbeentakenonfilemaintainedbytheCentralGovernmentthroughelectronicmodeand

onthebasisofstatementofcorrectnessgivenbythefilingcompany

FORMBFORMOFCOMPLIANCEREPORT

[Seerule2,andrule5]

I or We ........................................... being in permanent employment of the company or in

practice,

and

having

been

appointed

as

cost

accountant

under

Rule

5

of

the

Cost

Accounting

Records(PharmaceuticalIndustry)Rules,2011of...........................................................(mention

nameof thecompany)having its registeredoffice at ..................................................... (mention

registered

office

address

of

the

company) (hereinafter referred to as the company), have

examinedthebooksofaccountprescribedunderclause(d)ofsubsection(1)ofsection209ofthe

saidAct,andotherrelevantrecordsfortheperiod/year.............................(mentionthefinancial

year)andcertifyasunder:


9/28

9

1 IorWehaveorhavenotobtainedalltheinformationandexplanations,whichtothebestof

myorourknowledgeandbeliefwerenecessaryforthepurposeofthiscompliancereport.

2 Inmyorouropinion,propercostrecords,aspertheCostAccountingRecords(Pharmaceutical

Industry) Rules, 2011 prescribed under clause (d) of subsection (1) of section 209 of the

CompaniesAct,1956,haveorhavenotbeenmaintainedbythecompanysoastogiveatrue

and fair view of the cost of production or operation, cost of sales and margin of all the

productsandactivitiesofthecompany.

3 Detailed unitwise and product or activitywise cost statements and schedules thereto in

respectoftheproductgroupsoractivitiesareorarenotkeptinthecompany.

4 Inmyorouropinion,thesaidbooksandrecordsgiveordonotgivetheinformationrequired

bytheCompaniesAct,1956inthemannersorequired.

5 In my or our opinion, the said books and records are or are not in conformity with the

generally accepted cost accounting principles and cost accounting standards issued by The

Instituteof

Cost

and

Works

Accountants

of

India,

to

the

extent

these

are

found

to

be

relevant

andapplicable.

Dated: this____ day of_________ 20__ at_________________ (mention name of place of

signing

this

report)

SIGNATUREANDSEALOFTHECOSTACCOUNTANT(S)

MEMBERSHIPNUMBER(S)

NOTES:

(i) Deletewordsnotapplicable.

(ii) Ifasaresultoftheexaminationofthebooksofaccount,thecostaccountantdesiresto

point out any material deficiency or give a qualified report, he shall indicate the same

againsttherelevantpara.

(iii) Brieflygiveyourobservationsandsuggestions,ifany,relevanttothemaintenanceofcost

accountingrecordsbythecompany.

(iv) Costaccountantmayuseseparatesheet(s)for(ii)and(iii)above,ifrequired.


10/28

10

ANNEXURETOTHECOMPLIANCEREPORT

[Seerule2andrule5]

1.GENERAL:

a)

Nameofthecompany:

b)

Registeredoffice

address:

c)

FinancialyeartowhichtheComplianceReportrelates.

2.QUANTITATIVEINFORMATION:

NetSalesSno. NameoftheProductorService

Group

Unit Annual

Production

(Qty.)

(Qty.) (Valuein

Rupees)

A ProducedorManufacturedProduct

Groups

1.

2.

3.etc.

B ServicesGroups

1.

2.

3.etc.

C TradingActivities(ProductGroup

wise)

1.

2.

3.etc.

D

OtherIncome

TotalIncomeasperFinancialAccounts

3.RECONCILIATIONSTATEMENT:

NetMargin(ProfitorLoss)asperCostAccounts (InRupees)

A.FromProducedorManufacturedProductGroups

B.FromServicesGroups

C.FromTradingActivities

TotalasperCostAccounts

Add:IncomesnotconsideredinCostAccounts(ifany)

Less:ExpensesnotconsideredinCostAccounts(ifany)

Add/Less:Difference

in

Stock

Valuation

Profitor(Loss)asperFinancialAccounts

NOTES:

(i) Forproducedormanufacturedproductgroups,usethenomenclatureasusedinthe

CentralExciseActorRules,asapplicable.


11/28

11

(ii)

For services groups, use the nomenclature as used in the Finance Act or Central

ServiceTaxRules,asapplicable.

SIGNATURE

NAME

COSTACCOUNTANT(S)

MEMBERSHIPNUMBER(S)

SEAL

DATE

"SCHEDULE

[Seerule4]

PROFORMAA

StatementshowingcostofUtilitieslikeWaterorPoweretc.

NameoftheCompany

Nameof

the

Unit

NameoftheUtility

Fortheperiod

IQuantitativeInformation

Sno. Particulars Unit Currentyear Previousyear

1 InstalledCapacity

2 QuantityProduced

3 CapacityUtilization(%)

4 Quantityrecirculated

5 QuantityPurchased,ifany

6 Selfconsumptionincludinglosses(tobespecified)

7 NetUnitsAvailable

IICostInformation:

CostperUnitQuantity Rateper

unit

Amount

Current

Year

Previous

Year

Sno. Particulars

Unit Rs. Rs. Rs. Rs.

1 MaterialsConsumed(specify)

Indigenous

Imported

SelfManufactured/Produced

2. ProcessMaterials/Chemicals

(specify)

3.

Utilities

(specify):

4. DirectEmployeesCost

5. DirectExpenses(specify)

6. ConsumableStoresandSpares

7. RepairsandMaintenance

8. Depreciation

9. Leaserent,ifany

10. Otheroverheads

11. Subtotal(1to11)

12. Less:Credit,ifany


12/28

12

CostperUnitQuantity Rateper

unit

Amount

Current

Year

Previous

Year

Sno. Particulars

Unit Rs. Rs. Rs. Rs.

13. Totalcost(1211)

Apportionment:(costcentrewise)

1.CostCentre1

2.Cost

Centre

2

3.CostCentre3

Total

PROFORMAB

StatementshowingSummaryQuantitativeDetailsofallIntermediatesorBulkDrugs

ProcessedorManufactured

NameoftheCompany

NameandaddressoftheFactory

DrugLicenceNo.&Date

Fortheperiod

Sno. Particulars Unit CurrentYear PreviousYear

1. i)InstalledCapacity

ii)Capacitybyleasingarrangementsetc

TotalCapacity

2. Production:

a. DedicatedPlant

b.

Multipurpose EquipmentorPlant

c. UnderLoanLicenceifany

Total

3. AverageWorkingHoursperday

4.

ActualOperating

Days

in

ayear

Particulars QuantityperUnit QuantityperUnit

5. GrossInputs: Standard Actual Standard Actual

a) IntermediateorIngredient1:

MaterialsConsumed(specify)

ProcessChemicals(specify)

Utilities(specify)

Total

b) IntermediateorIngredient2:



Utilities(specify)

Total

c)

Intermediateor

Ingredient

3:



Utilities(specify)

Total

ProvidedetailsofallIntermediatesorIngredientsorBulkDrugsseparatelyasaboveunderSno.5.


13/28

13

PROFORMAB1

StatementshowingCostofProductionofIntermediatesorBulkDrugsProcessedor

Manufactured

NameoftheCompany


DrugLicence

No.

and

Date

NameofIngredientorIntermediate orBulkDrug

Fortheperiod

I.QuantitativeInformation:


1. BatchSize

2. NumberofBatchesProduced

3. ActualYield%

4. StandardYield%

5. Production

IICostInformation:

Costper

Unit

Rate

Amount

Current

Year

Previous

Year

Sno.

Particulars

Unit

Quantity

Rs. Rs. Rs. Rs.

1. MaterialsConsumed(specify)

a) Indigenouspurchased

b) Imported

b) Selfmanufactured/produced

Total

2 ProcessChemicals(specify)

3 Utilities(specify)

4 DirectEmployeesCost

5 DirectExpenses(specify)

6

ConsumableStores

and

Spares

7 RepairsandMaintenance

8 QualityControlExpenses

9 ResearchandDevelopment

10 TechnicalknowhowFee

11 DepreciationorAmortization

12 OtherProductionOverheads

13 Total (1to12)

14 Add,OpeningStockinProcess

Less,ClosingStockinProcess

Balance

15 Less:CreditsfromRecoveries

16 CostofProduction

III

ALLOCATEDTO

1.

2.

3.(specify)

Total


14/28


15/28

15

CostperUnitRate Amount

Current

Year

Previous

Year

Sno. Particulars Unit Quantity

Rs. Rs. Rs. Rs.

13. TotalCost

14. NetSalesRealisation

15. Margin

16.

Add:Export

Benefits

and

Incentives,ifany

17. TotalMargin(including

exportbenefits)

PROFORMAD

StatementshowingCostofProductionofIntermediatesorBulkDrugorFormulation

processedonJobChargesbasis

NameoftheCompany

Nameand

address

of

the

Job

Processor

DrugLicenceNo.andDate

NameofIngredientorIntermediate orBulkDrug

Fortheperiod

I.QuantitativeInformation:


1. MaterialSenttoProcessor(specifydetails}

a) RawMaterials

b)

Ingredients

c)

BulkDrugs

d)

PackingMaterials

2. OpeningStockofMaterials

a)

RawMaterials

b) Ingredients

c) BulkDrugs

d) PackingMaterials

3. ClosingStockofMaterials

a) RawMaterials

b) Ingredients

c) BulkDrugs

d) PackingMaterials

4. MaterialConsumed(specifydetails}

a)

RawMaterials

b) Ingredient

c)

BulkDrugs

d)

PackingMaterial

5. Normalwastageofmaterial

6. Abnormalwastageofmaterial

7. QuantityProduced

a)

BulkDrugs

b)

Formulations

8. QuantityProduced(asperExciseRecords)

a) BulkDrugs

b)

Formulations


16/28

16

IICostInformation:

CostperUnitRate Amount

Current

Year

Previous

Year

Sno. Particulars Unit Quantity

Rs. Rs. Rs. Rs.

1. MaterialsConsumedby

Processor(specify)

2. ProcessingCharges

3. Add,OpeningStockin

Process


Balance

4. Less:Creditsfrom

Recoveries

5. CostofProduction

6. Add,OpeningStock

Unpacked

Less,ClosingStock

Unpacked

7.

PackingMaterial

Cost

8. CostofPackedProduction

Add,OpeningStockPacked

Less,ClosingStockPacked

9. BalanceReceivedfrom

Processor

ALLOCATEDTO:

1.

2.

3.

(etc.)


17/28

17

PROFORMAE

StatementshowingAllocationandApportionmentofTotalExpensesandConversionandPackingCost

Nameofthecompany

Period

Sno. Particulars Total

Expensesas

perAudited

Financial

Accounts

Utilities

(separately

foreach)

Production

CostCentres

(specify

separately)1

PackingCost

Centres(specify

primaryor

secondary

separately)2

Factory

Overheads

Adminis

tion

Overhe

QuantitativeDetails

No.ofBatches

QuantityInput

QuantityOutput

MachineHoursorLabourHours

a)

Available

b) Worked

CostInformation:

1. DirectMaterials(specify)

2. ProcessChemicals(specify)

3. Chemicals(specify)

4. PowerandFuel

5. EmployeeBenefits:

a) Salaries,Wages,BonusEtc.

b) ContributiontoProvidentandOtherFunds

c)

StaffWelfare

Expenses

6. ConsumableStoresandSpares

7. RepairsandMaintenance

a) PlantandMachinery


18/28

18


Expensesas

perAudited

Financial

Accounts

Utilities

(separately

foreach)

Production

CostCentres

(specify

separately)1

PackingCost

Centres(specify

primaryor

secondary

separately)2

Factory

Overheads

Adminis

tion

Overhe

b) Buildings

c) Others

8. OtherDirectExpenses(specify)

9. Rent

10. Insurance

11. RatesandTaxes

12. PaymentToAuditors

13. TravelingandConveyance

14. CommunicationExpenses

15. PrintingandStationery

16. BankCharges

17. SecurityForceExpenses

18. SalesPromotionExpenses

19. HandlingExpenses

20. MiscellaneousExpenses

21. TransportationCharges

22. QualityControl

23. RoyaltyorTechnicalKnowhow

24. TechnicalAssistantFees

25. OtherStatutoryLevies

26. LeaseRent

27. ResearchandDevelopment

28. PackingExpenses

29. BorrowingCharges

30. LossonAssetsSold,LostorWrittenOff


19/28

19


Expensesas

perAudited

Financial

Accounts

Utilities

(separately

foreach)

Production

CostCentres

(specify

separately)1

PackingCost

Centres(specify

primaryor

secondary

separately)2

Factory

Overheads

Adminis

tion

Overhe

31. ExchangeRateFluctuations

32. ProvisionForDoubtfulDebts,Advances,ClaimsandObsolescence

33. ProvisionforContingencies

34. DepreciationorDepletion

35. TotalExpenses

36. AllocationofUtilities(specify)

37. ApportionmentofOverheads(specify

38. Total

39. Less,CostofMaterialsandBoughtOut

Components

40.

ConversionCost

(38

39)

41. CostperMachineHourorDirectLabour

Hour

42. CurrentYear

43. PreviousYear

1. SpecifycostcentresasWeighingandMixing,Filtration,TabletMaking,Preparation,Inspection,Testing,QualityControletcunderProduct

2. PackingcostcentrestobeshownseparatelyunderCartooning,Boxing,etc.underPrimaryorSecondaryPackingcostcentres.


20/28

20

ReconciliationControl:


Expensesas

perAudited

Financial

Accounts

Utilities

(separately

foreach)

Production

CostCentres

(specify

separately)

PackingCost

Centres

(specify

primaryor

secondary

separately

Factory

Overheads

Administ

tion

Overhea

1. TotalExpensesb/fasperSno.35above

2. Add,OpeningStockinProcess


3. Less,CreditforRecoveries

4. Less,SelfConsumption,ifany,

5. Add,OpeningStockFinished

Less,ClosingStockFinished

6. Total(excludingExciseDuty)

7.

ExciseDuty

Paid

8. Total(includingExciseDuty)

9. TotalSalesRealization(excludingExcise

Duty

10. ExciseDutyRecovered

11. TotalSales(includingExciseDuty)

12. Add:ExportBenefit,ifany

13. ProfitasperProfitandLossAccount


21/28

21

PROFORMAF

StatementshowingApportionmentofConversionCostandPackingCostforvariousPro

NameoftheCompany

Nameand

address

of

the

Factory

DrugLicenceNo.andDate

Fortheperiod

Sno. ProductorFormulation

(specify)

Size Qty Total CostCentres(SpecifyNamesofcostcentres such

asWeighing&Mixing,Filtration,TabletMaking,

Preparation,Inspection,Testing,QualityControl

etc.incolumns below)

Total Cost

asW

Prep

1 2 3 4 5 6 7 8 9 10 1

X Y X Y X Y X Y X Y X Y X

Hrs Rs. Hrs Rs. Hrs Rs. Hrs Rs. Hrs Rs. Hrs Rs. Hrs

Apportionmentof A. ConversionCost toProductorFormulations B. Pa

1

2

3

4

4

6

Etc.

Total

X=Actualdirectlabourormachinehoursutilizedasperactualrecordingoranyotherappropriatebasisofapportionm

Y=ConversionCostinrupees


22/28

22

PROFORMAG

StatementshowingCostofProduction,CostofSales,SalesRealizationandMarginin

respectofFormulation

NameoftheCompany


DrugLicence

No.

and

Date

NameoftheFormulation/Drug

Fortheperiod

Sno. Particulars

1 Nameoftheformulation(withtrademark)manufactured ormarketedanditscomposition

2 TypeofFormulations:PlainorCoatedTablet,SoftorHardorPrintedCapsuleswithorwithout

Band,SterileorNonsterileLiquidPowderorOintmentorCreametc.(specify)

3 TypeofPacking:AluminumorPaperorCellophaneorBlisterorStripeorVialsorAmpouleor

BottleorTinorJaretc.(specify)

4 SizeofPacking(specify)

5 BatchSize(Specify)

Standard Actual

6

Production

Current

YearPrevious

YearCurrent

YearPrevious

Year

I No.ofBatchesCharged

II No.ofBatchesProduced

III TotalQuantityProduced

IV QuantityPacked

V PackedQuantitySold

(a) QuantitySoldineachpacksize

(b) TotalnumberofPacksSold

VI AssessableValueoftheproductreconciledwith

ExciseRecords

Quantity Rate Amount CostPerunitSno. Particulars Unit

Theore

ticalActual

Rs.

Rs.

Current

YearPrevious

Year

A MaterialsConsumed

(a) Imported(specifyinput)

(b) Indigenous(specifyinputs)

(c) OwnProducedorManufactured

(Specifymajoritems)

(d) Less:WastesorRejects

(e) TotalMaterialCost(A)

B PrimaryPackingMaterial

(a) AluminumorPVCorCellophane,

BlisterFoiletc.forfrontuse

(b) AluminumorPVCorCellophane,

BlisterFoil

etc.

for

back

side

(c) BottleorContainerorTubeetc

(d) Ampoules/Vialsetc

(e) Capsulesetc.

(f) Leaflets

(g) Cartons

(h) Others(specify)

(i) Less:WastesorRejects

(j) TotalPackingMaterials(B)

C ConversionCost


23/28

23


Theore

tical

Actual Rs. Rs. Current

Year

Previous

Year

(a) WeighingandMixing

(b) Filtration

(c) PreparationofSolutionor

Ointment

(d)

Inspection

(e) QualityControl

(f) Testing

(g) ResearchandDevelopment

(h) Others(specify)

(i) TotalConversionCost(C)

D PackingCost(D)

E OtherExpenses

(a) Royalty

(b) Storage

(c) Others(specify)

(d) Total(E)

F TotalCost(A+B+C+D+E)

G

Add:Opening

Work

in

Progress

Less:ClosingWorkinProgress

H AdjustmentforCostVariance

I TotalProductionCost(FtoH)

J SecondaryPackingMaterials

(a) Cartoons

(b) Leaflets

(c) Dropper

(d) Boxes

(e) GumTapes

(f) Others(specify)

(g) Less:WastesorRejects

(h) Total(atog)

K

SecondaryPacking

Cost

or

Charges

(a) Cartooning

(b) Boxing

(c) Others(specify)

(d) Total(atoc)

L TotalCostofPackedProduction

(I+J+K)

M Less:TransferforClinicalor

SampleorTrailsetc.

N Balance(L+M)

O Add:OpeningStockPacked

Less:ClosingStockPacked

P

BalanceSold

Q AdministrationOverheads

R CostofGoodsSold(P+Q)

(a) DomesticSales

(b) ExportSales

(c) Total(a+b)

S1 DistributionCost(specify)

a)

b)

c)etc


24/28

24


Theore

tical

Actual Rs. Rs. Current

Year

Previous

Year

S2 SalesPromotionExpenses

(a) Wholesalers

(b) CandFAgents

(c) Retailers

(d)

Others(specify)

S3 TradeCommission

(a) Wholesalers

(b) CandFAgents

(c) Retailers

(d) Others(specify)

T Total(R+S1+S2+S3)

U InterestandFinancingCharges

V OtherExpensesorIncomenot

includedinCost(givedetails)

W TotalCost ofSalesexcluding

ExciseDuty

X NetSalesRealizationexcluding

ExciseDuty

(a)

(b)

(c)

DomesticSales

ExportSales

Add:Export Benefitsand

Incentives

(d) Total(atoc)

Y Margin(NM)

Z1 MaximumRetailPriceexcluding

ExciseDuty

Z2 MaximumPriceunderDPCOas

applicable

Z3 AssessableValueoftheProduct

Z4 ExciseDuty


25/28

25

ProformaH

StatementshowingActivitywiseCapitalCostofPlantandMachinery/EquipmentrelatingtoBulkDrugs,Formulati

Activities

Nameofthecompany:

ForthePeriod:

GrossBlock DepreciationSno. Particulars

Costasat

beginning

oftheyear

Additionsor

Transfers

duringthe

year

Deductions

orTransfer

duringthe

year

TotalCost

attheend

oftheyear

Asat

beginning

oftheyear

Fortheyear On

deductions

duringthe

year

A. Ingredients(specify)

1.

2.

etc

B. BulkDrugActivity(specify)

1.

2.

etc

C. Formulations(specify)

1.

2.

etc

D. Packing

1.

2.

etc

E. Utilities(specify)

1.

2.

etc

F. Common(Production/Administrative/Marketing)Overheads(specify)

1.

2.

etc

H. GrandTotal(AtoG)


26/28


27/28

27

maintainedonannualaveragebasis:

(a) number of fermenters with their operating capacity or volume, average

fermentationhoursandturnaroundtime;

(b) averagewholebrothvolume,wholebrothpotencyand filteredbrothpotencyper

batch;

(c) stagewiseandoverallpercentagerecoveryefficiencyofbothdrugandintermediate

fromthefermentedbroth;

(d) averagebatchoutputandnumberofbatchesprocessedanddrained;

(e) averagepotency/purityofthefinisheddrug;and

(f) stagewise annual average quantity consumption of all major raw materials

includingsolventsusageshallbemaintainedalongwithquantityproducedateach

stage.Similarlydetailsofconsumptionofprimaryutilitiesof inrespectofthedrug

shallbemaintained.

4

Ifthe

drug

is

manufactured

by

chemical

process,

the

following

details

shall

also

be

maintained,namely:

(a) In the case of dedicated facilities, details such as name of the equipment and

designedcapacity,numberofequipmentsavailable,positionorcodenumberofthe

equipment,reactionoroperationcarriedoutintheequipment,batchsize(inputor

batchandoutputorbatch),occupancy timehour,yieldandWIW with respect to

main input at each stage and the cumulative yield, byproduct or recoveries of

solventsetc.(Kg.orLtr.).

(b) In case any other product is manufactured in the above set of equipment similar

datashall

be

maintained

for

such

item

and

allocation

of

time

at

each

equipment

alongwithbasisofallocation.

5 Appropriatechemicalequationofreactionwithmolecularweightandrecoverylevelsof

solventsandbyproductateachstageshallalsobekept.Further,incaseofanychange

intheprocessoftechnologyandtheconsequentialbenefittherefromduringtheyear

orintherecentpastshallbemaintained.

6 Actualquantityconsumedincludingoverages,ifanyshouldbeincludedinProformaG.

7 The items of cost shown in the Proforma are indicative and the same should be

reflectedKeepinginmindthematerialityoftheitemofcostintheproduct.

8

Separateproforma

shall

be

prepared

for

the

quantity

sold

within

the

country

and

the

quantityexported.Expensesincurredonexportandtheincentiveearnedthereonshall

be indicated in theproformaapplicable for thequantityproducedandexported.The

valueofexport incentivesandotherbenefitsreceivedonexportsshallbe included in

salesrealization.Separatecostdetailsshallbemaintainedforexpenditureincurredfor

gettingaccreditationfromoverseasregulatoryauthoritiesanditsrecurringexpenditure

thereof, if any. This cost shall be charged to products exported on scientific and


28/28

PHARMA_CARR_874E.pdf

Documents