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1

[TO BE PUBLISHED IN THE GAZETTE OF INDIA, EXTRAORDINARY, PART

SECTION

II,3, SUBSECTION (i)]

MINISTRY OF CORPORATE AFFAIRS

Notification

New Delhi dated the 7

G.S.R. 874 (E).

read with clause (d) of sub

1956), and in supersession of the Cost Accounting Records (Bulk Drugs) Rules, 1974 vide

G.S.R. 130(E), dated the 14

Rules, 1988 vide G.S.R. 452, dated the 22

omitted to be done before such supersession, the Central Government hereby makes the

following rules, namely:

th, Dec, 2011In exercise of the powers conferred by subsection (1) of section 642,section (1) of section 209 of the Companies Act, 1956 (1 ofth March, 1974 and Cost Accounting Records (Formulations)nd April, 1988, except as respects things done or

1.

Records (Pharmaceutical Industry) Rules, 2011.

(2) They shall come into force on the date of their publication in the Official Gazette.

2.

Short Title and Commencement, – (1) These rules may be called the Cost AccountingDefinitions and Interpretations, – In these rules, unless otherwise requires,‐‐‐

(a) “Act” means the Companies Act, 1956 (1 of 1956);

(b)

including its salts, esters, stereo

such or as an ingredient in any formulation and shall include any bulk drug

included in any bona fide Allopathic, Ayurvedic, Homeopathic, Sidha or Unani

(Tibb) systems of medicine;

“bulk drugs" means any pharmaceutical, chemical, biological or plant productisomers and derivatives, which are used as

(c)

signed by a cost accountant in the specified form of compliance report;

(d) “Cost Accountant” for the purpose of these rules means

defined in clause (b) of sub

Accountants Act, 1959 (23 of 1959) and who is either a permanent employee

of the company or holds a valid certificate of practice under sub

section 6 and who is deemed to be in practice under sub

2 of that Act and includes a firm of cost accountants;

“compliance report” means the compliance report duly authenticated anda cost accountant assection (1) of section 2 of the Cost and Workssection (1) ofsection (2) of section

(e) “Cost Accounting Standards” means the standards of cost accounting, issued

by the Institute;

(f) “cost records” means books of account relating to utilisation of materials,

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

manufacturing or mining activities of the company;

2

(g) “Form

and other documents with the Central Government in the electronic mode;

(h) “Form

the compliance report;

(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

medicine included in any bona fide Allopathic, Ayurvedic, Homeopathic, Sidha

or Unani (Tibb) systems of medicine;

(j) “Generally Accepted Cost Accounting Principles” means the principles of cost

accounting issued by the Institute;

(k) “Institute” means the Institute of Cost and Works Accountants of India

constituted under the Cost and Works Accountants Act, 1959 (23 of 1959);

(l) “pharmaceutical activities” means production, processing, or manufacturing of

bulk drugs or formulations and includes the meaning assigned to them under

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

included under Chapters 29 and 30 of the Central Excise Tariff Act, 1985 (5 of

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

products thereof;

(m) “product” means any tangible or intangible good, material, substance, article,

idea, know

human, mechanical, industrial, chemical, or natural act, process, procedure,

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

consumption, sale, transport, store, delivery or disposal;

(n) “product group” in relation to tangible products means a group of

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

using similar or same production process, having similar physical or chemical

characteristics and common unit of measurement, and having same or similar

usage or application; and in relation to intangible products means a group of

homogenous and alike products or services, produced by using similar or same

process or inputs, having similar characteristics and common unit of

measurement, and having same or similar usage or application;

(o) “turnover” means total turnover made by the company from the sale or supply

of all products or services during the financial year and it includes any turnover

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

incentives received but does not include any non

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

defined in the Act and rules made under clause (d) of sub

A” means the form specified in these rules for filing compliance reportB” means the form of the compliance report and includes Annexure tohow, method, information, object, service, etc. that is the result ofoperational income;section (1) of section

3

209 of the Act shall have the same meanings as assigned to them in the Act or

rules, as the case may be.

3.

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

processing, or manufacturing of pharmaceutical activities and wherein, the aggregate

value of net worth as on the last date of the immediately preceding financial year

exceeds five crores of rupees; or wherein the aggregate value of the turnover made

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

the company’s equity or debt securities are listed or are in the process of listing on

any stock exchange, whether in India or outside India:

Application, – These rules shall apply to every company, including a foreign company

Provided that these rules shall not apply to a body corporate governed by any

special Act.

4.

units and branches thereof shall, in respect of each of its financial year commencing

on or after the date of this notification, keep cost records and the books of account

so maintained shall contain, inter

mentioned in the Schedule annexed to these rules.

(2) The cost records referred to in sub

such manner so as to make it possible to calculate per unit cost of production

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

activities for every financial year on monthly or quarterly or half

annual basis.

(3) The cost records shall be maintained in accordance with the generally

accepted cost accounting principles and cost accounting standards issued by

the Institute; to the extent these are found to be relevant and applicable and

the variations, if any, shall be clearly indicated and explained.

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

company to exercise, as far as possible, control over 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

required to be furnished under these rules.

(5) All such cost records and cost statements, maintained under these rules shall

be reconciled with the audited financial statements for the financial year

specifically indicating expenses or incomes not considered in the cost records

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

product groups with the overall profit of the company and the variations, if

any, shall be clearly indicated and explained.

Maintenance of records, – (1) Every company to which these rules apply, including allalia, the particulars specified in Proformae A to Irule (1) shall be kept on regular basis inyearly or

4

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

maintained under these rules,

financial years immediately preceding a financial year or where the company

had been in existence for a period less than eight years, in respect of all the

preceding years shall be kept in good order.

relating to a period of not less than eight

(7) Every person, referred to in sub

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

manner as he is liable to maintain accounts required under sub

section 209 of the said Act.

5.

submit a compliance report, in respect of each of its financial year commencing on or

after the date of this notification, duly certified by a Cost Accountant, along with the

Annexure to the Central Government, in the specified form.

6.

compliance report referred to in rule 5 to the Central Government within a period of

one hundred and eighty

the compliance report relates.

7.

compliance report shall be approved by the Board of Directors and certified by the

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

company.

8.

provisions of these rules, he shall be punishable with fine, which may extend to five

thousand rupees.

(2) For contravention of these rules,

section (6) and (7) of section 209 of thesection (1) ofForm of the Compliance Report, – Every company to which these rules apply shallTime limit for submission of Compliance Report, – Every company shall submit thedays from the close of the company’s financial year to whichAuthentication of Annexure to the Compliance Report, – The Annexure to thePenalties, – (1) If default is made by the Cost Accountant in complying with the

(a) the company shall be punishable as provided under sub

section 642 of the Act; and

(b) every officer thereof who is in default, including the persons referred to in

sub

under sub

1956).

9.

and Cost Accounting Records (Formulations) Rules, 1988, shall not in any way affect

section (2) ofsection (6) of section 209 of the Act, shall be punishable as providedsections (5) and (7) of section 209 of Companies Act, 1956 (1 ofSavings, – The supersession of the Cost Accounting Records (Bulk Drugs) Rules, 1974

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

thereunder;

5

(b) any penalty, forfeiture or punishment incurred in respect of any

contravention committed thereunder; and

(c) any investigation, legal proceeding or remedy in respect of any such right,

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

aforesaid, and; any such investigation, legal proceeding or remedy may be

instituted, continued or enforced and any such penalty, forfeiture or

punishment may be imposed as if those rules had not been superseded.

6

FORM

documents with the Central Government

[Pursuant to section 209(1)(d), 600(3)(b) of the Companies Act, 1956 and rule 2 of the Cost Accounting

Records (Pharmaceutical Industry) Rules, 2011]

PART I

Note: All fields marked in * are to be mandatorily filled.

A Form for filing Compliance Report and otherGENERAL INFORMATION

1 (a) *Corporate identity number (CIN) or

foreign company registration number of

the company

Pre

Fill

(b) Global location number (GLN) of

company

2 (a) *Name of the company

(b) *Address of the registered office or of

the principal place of business in India

of the company

(c) *E

3 (a) *Financial year covered by the

compliance report

From

(DD/MM/YYYY)

To (DD/MM/YYYY)

(b) *Date of Board of directors’ meeting in which annexure

to the compliance report was approved

(DD/MM/YYYY)

4.

mail Address of the companyDetails of the cost accountant

(a) *Category of the cost accountant Individual Cost accountant’s

firm

(b) In case of individual, whether the cost accountant

is in permanent employment of the company or in

practice

In Employment In Practice

(c) *Name of the cost accountant or the

cost accountant’s firm who has certified

the cost records of the company

(d) *Income tax permanent account number of the cost accountant or the cost

accountant’s firm

7

(e) *Membership number of cost accountant or cost accountant’s firm’s

registration number

(f) Address of the cost accountant or cost accountant’s firm

(i) Line I

Line II

(ii) City

(iii) State

(iv) Country

(v) Pin Code

(g) *E

cost accountant’s firm

5.

mail ID of the cost accountant or*Quantitative Information

Sno. Name of the Product or Service Group Unit Annual Net Sales

Production

(Quantity)

(Quantity) (Value in

Rupees)

A Produced or Manufactured Product

1.

2.

3. etc.

B Services Groups

1.

2.

3. etc.

C Trading Activities (Product Group

1.

2.

3. etc.

D Other Income

Total Income as per Financial Accounts

wise)

PART

Attachments:

II

1

Compliance report as per the Cost Accounting

Records(Pharmaceutical Industry) Rules, 2011

Attach

2 Optional attachments(s) – if any

Attach

List of attachments

8

Remove attachment

Verification:

To the best of my knowledge and belief, the information given in this form and its attachments is correct

and complete.

I have been authorised by the Board of directors’

resolution number

dated

(DD/MM/YYYY)

to sign and submit this form.

I am authorised to sign and submit this form.

To be digitally signed by:

Managing Director or director or manager or secretary (in case of an Indian company)

or an authorised representative (in case of a foreign

company)

Digital

Signatures

*Designation

*Director identification number of the director or Managing Director; or Income

of the manager or of authorised representative; or Membership number, if applicable or

income

may quote his/her income

Director of the company

Digital

Signatures

Director identification number of the director

tax PANtax PAN of the secretary (secretary of a company who is not a member of ICSItax PAN)

Modify Check Form Pre

This e

on the basis of statement of correctness given by the filing company

scrutiny Submitform has been taken on file maintained by the Central Government through electronic mode and

FORM

B

FORM OF COMPLIANCE REPORT

[See rule 2, and rule 5]

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 (Pharmaceutical Industry) Rules, 2011 of …...........................................................

name of the company)

registered office address of the company)

examined the books of account prescribed under clause (d) of sub

said Act, and other relevant records for the period/year .............................

year)

(mentionhaving its registered office at ..................................................... (mention(hereinafter referred to as the company), havesection (1) of section 209 of the(mention the financialand certify as under:

9

1 I or We have or have not obtained all the information and explanations, which to the best of

my or our knowledge and belief were necessary for the purpose of this compliance report.

2 In my or our opinion, proper cost records, as per the Cost Accounting Records (Pharmaceutical

Industry) Rules, 2011 prescribed under clause (d) of sub

Companies Act, 1956, have or have not been maintained by the company so as to give a true

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

products and activities of the company.

3 Detailed unit

respect of the product groups or activities are or are not kept in the company.

4 In my or our opinion, the said books and records give or do not give the information required

by the Companies Act, 1956 in the manner so required.

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

Institute of Cost and Works Accountants of India, to the extent these are found to be relevant

and applicable.

Dated: this ____ day of _________ 20__ at _________________ (

signing this report

SIGNATURE AND SEAL OF THE COST ACCOUNTANT (S)

MEMBERSHIP NUMBER (S)

NOTES:

(i) Delete words not applicable.

(ii) If as a result of the examination of the books of account, the cost accountant desires to

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

against the relevant para.

(iii) Briefly give your observations and suggestions, if any, relevant to the maintenance of cost

accounting records by the company.

(iv) Cost accountant may use separate sheet(s) for (ii) and (iii) above, if required.

section (1) of section 209 of thewise and product or activitywise cost statements and schedules thereto inmention name of place of)

10

ANNEXURE TO THE COMPLIANCE REPORT

[See rule 2 and rule 5]

1. GENERAL:

a) Name of the company:

b) Registered office address:

c) Financial year to which the Compliance Report relates.

2. QUANTITATIVE INFORMATION:

Sno. Name of the Product or Service Net Sales

Group

Unit Annual

Production

(Qty.)

(Qty.) (Value in

Rupees)

A Produced or Manufactured Product

Groups

1.

2.

3. etc.

B Services Groups

1.

2.

3. etc.

C Trading Activities (Product Groupwise)

1.

2.

3. etc.

D Other Income

Total Income as per Financial Accounts

3. RECONCILIATION STATEMENT:

Net Margin (Profit or Loss) as per Cost Accounts (In Rupees)

A. From Produced or Manufactured Product Groups

B. From Services Groups

C. From Trading Activities

Total as per Cost Accounts

Add: Incomes not considered in Cost Accounts (if any)

Less: Expenses not considered in Cost Accounts (if any)

Add/Less: Difference in Stock Valuation

Profit or (Loss) as per Financial Accounts

NOTES:

(i) For produced or manufactured product groups, use the nomenclature as used in the

Central Excise Act or Rules, as applicable.

11

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

Service Tax Rules, as applicable.

SIGNATURE

NAME

COST ACCOUNTANT (S)

MEMBERSHIP NUMBER (S)

SEAL

DATE

"SCHEDULE”

[See rule 4]

PROFORMA ‘A’

Statement showing cost of Utilities like Water or Power etc

.

Name of the Company

Name of the Unit

Name of the Utility

For the period

I Quantitative Information

Sno. Particulars Unit Current year Previous year

1 Installed Capacity

2 Quantity Produced

3 Capacity Utilization (%)

4 Quantity re

5 Quantity Purchased, if any

6 Self consumption including losses (to be specified)

7 Net Units Available

circulated

II Cost Information

:

Quantity Rate per Cost per Unit

unit

Amount

Current

Year

Previous

Year

Sno. Particulars

Unit Rs. Rs. Rs. Rs.

1 Materials Consumed (specify)

Indigenous

Imported

Self Manufactured/Produced

2. Process Materials/ Chemicals

(specify)

3. Utilities (specify):

4. Direct Employees Cost

5. Direct Expenses (specify)

6. Consumable Stores and Spares

7. Repairs and Maintenance

8. Depreciation

9. Lease rent, if any

10. Other overheads

11. Sub

12. Less: Credit, if any

total (1 to11)

12

Quantity Rate per Cost per Unit

unit

Amount

Current

Year

Previous

Year

Sno. Particulars

Unit Rs. Rs. Rs. Rs.

13. Total cost (12

Apportionment: (cost centre

11)wise)

1. Cost Centre 1

2. Cost Centre 2

3. Cost Centre 3

Total

PROFORMA ‘B’

Statement showing Summary Quantitative Details of all Intermediates or Bulk Drugs

Processed or Manufactured

Name of the Company

Name and address of the Factory

Drug Licence No. & Date

For the period

Sno. Particulars Unit Current Year Previous Year

1. i) Installed Capacity

ii) Capacity by leasing arrangements etc

Total Capacity

2.

Production:

a. Dedicated Plant

b. Multipurpose Equipment or Plant

c. Under Loan Licence if any

Total

3. Average Working Hours per day

4. Actual Operating Days in a year

Particulars Quantity per Unit Quantity per Unit

5.

Gross Inputs: Standard Actual Standard Actual

a)

Intermediate or Ingredient 1:

Materials Consumed (specify)

Process Chemicals (specify)

Utilities ( specify)

Total

b)

Intermediate or Ingredient 2:

Materials Consumed (specify)

Process Chemicals (specify)

Utilities ( specify)

Total

c)

Intermediate or Ingredient 3:

Materials Consumed (specify)

Process Chemicals (specify)

Utilities ( specify)

Total

Provide details of all Intermediates or Ingredients or Bulk Drugs separately as above under Sno. 5.

13

PROFORMA ‘B

Statement showing Cost of Production of Intermediates or Bulk Drugs Processed or

Manufactured

1’

Name of the Company

Name and address of the Factory

Drug Licence No. and Date

Name of Ingredient or Intermediate or Bulk Drug

For the period

I. Quantitative Information:

Sno. Particulars Unit Current Year Previous Year

1. Batch Size

2. Number of Batches Produced

3. Actual Yield %

4. Standard Yield %

5. Production

II Cost Information:

Rate Amount Cost per Unit

Current

Year

Previous

Year

Sno. Particulars Unit Quantity

Rs. Rs. Rs. Rs.

1. Materials Consumed (specify)

a) Indigenous purchased

b) Imported

b) Self manufactured/ produced

Total

2 Process Chemicals (specify)

3 Utilities (specify)

4 Direct Employees Cost

5 Direct Expenses (specify)

6 Consumable Stores and Spares

7 Repairs and Maintenance

8 Quality Control Expenses

9 Research and Development

10 Technical know

11 Depreciation or Amortization

12 Other Production Overheads

how Fee

13 Total ( 1 to 12)

14 Add, Opening Stock in Process

Less, Closing Stock in Process

Balance

15 Less: Credits from Recoveries

16 Cost of Production

III ALLOCATED TO

1.

2.

3. (specify)

Total

14

PROFORMA ‘C’

Statement showing Cost of Sales, Sales Realization and Margin in respect of

Intermediates or Bulk Drug Processed or Manufactured and Sold

Name of the Company

Name and address of the Factory

Drug Licence No. and Date

Name of Ingredient or Intermediate or Bulk Drug

For the period

I. Quantitative Information:

Sno. Particulars Unit Current Year Previous Year

1. Production Transferred

2. Less, Captive Consumption

Balance

Opening Stock – Unpacked

Closing Stock – Unpacked

Packed Production

3. Opening Stock – Packed

4. Closing Stock – Packed

5. Balance

6. Quantity transferred for:

(a) Domestic Sale

(b) Export Sale

(c) Others (specify)

II Cost Information:

Rate Amount Cost per Unit

Current

Year

Previous

Year

Sno. Particulars Unit Quantity

Rs. Rs. Rs. Rs.

1. Cost of Production b/f

(Proforma B)

2. Less: Captive Consumption

for:

(a) Product 1

(b) Product 2 (etc.)

3. Balance Packed

4. Add, Opening Stock –

Unpacked

Less, Closing Stock –

Unpacked

5. Packing Cost

(a) Materials

(b) Others

6. Cost of Packed Production

7. Add, Opening Stock – Packed

Less, Closing Stock – Packed

8. Balance

9. Administrative Overhead

10. Selling and Distribution

Overheads

11.

Cost of Sales

12. Interest and Financing

charges

15

Rate Amount Cost per Unit

Current

Year

Previous

Year

Sno. Particulars Unit Quantity

Rs. Rs. Rs. Rs.

13.

Total Cost

14. Net Sales Realisation

15. Margin

16. Add: Export Benefits and

Incentives, if any

17. Total Margin (including

export benefits)

PROFORMA ‘D’

Statement showing Cost of Production of Intermediates or Bulk Drug or Formulation

processed on Job Charges basis

Name of the Company

Name and address of the Job Processor

Drug Licence No. and Date

Name of Ingredient or Intermediate or Bulk Drug

For the period

I. Quantitative Information:

Sno. Particulars Unit Current Year Previous Year

1.

Material Sent to Processor (specify details}

a) Raw Materials

b) Ingredients

c) Bulk Drugs

d) Packing Materials

2.

Opening Stock of Materials

a) Raw Materials

b) Ingredients

c) Bulk Drugs

d) Packing Materials

3.

Closing Stock of Materials

a) Raw Materials

b) Ingredients

c) Bulk Drugs

d) Packing Materials

4.

Material Consumed (specify details}

a) Raw Materials

b) Ingredient

c) Bulk Drugs

d) Packing Material

5.

Normal wastage of material

6. Abnormal wastage of material

7.

Quantity Produced

a) Bulk Drugs

b) Formulations

8.

Quantity Produced (as per Excise Records)

a) Bulk Drugs

b) Formulations

16

II Cost Information:

Rate Amount Cost per Unit

Current

Year

Previous

Year

Sno. Particulars Unit Quantity

Rs. Rs. Rs. Rs.

1. Materials Consumed by

Processor (specify)

2. Processing Charges

3. Add, Opening Stock in

Process

Less, Closing Stock in Process

Balance

4. Less: Credits from

Recoveries

5. Cost of Production

6. Add, Opening Stock –

Unpacked

Less, Closing Stock –

Unpacked

7. Packing Material Cost

8. Cost of Packed Production

Add, Opening Stock – Packed

Less, Closing Stock – Packed

9. Balance Received from

Processor

ALLOCATED TO:

1.

2.

3. (etc.)

17

PROFORMA ‘E’

Statement showing Allocation and Apportionment of Total Expenses and Conversion and Packing Cost for various Cost Centres

Name of the company

Period

(Amount in Rupees)

Sno. Particulars Total

Expenses as

per Audited

Financial

Accounts

Utilities

(separately

for each)

Production

Cost Centres

(specify

separately)

1

Packing Cost

Centres (specify

primary or

secondary

separately)

2

Factory

Overheads

Administration

Overheads

Marketing or

Selling and

Distribution

Other

Activities

Non Cost

Expenses

Quantitative Details

No. of Batches

Quantity Input

Quantity Output

Machine Hours or Labour Hours

a) Available

b) Worked

Cost Information:

1. Direct Materials (specify)

2. Process Chemicals(specify)

3. Chemicals (specify)

4. Power and Fuel

5. Employee Benefits:

a) Salaries, Wages, Bonus Etc.

b) Contribution to Provident and Other Funds

c) Staff Welfare Expenses

6. Consumable Stores and Spares

7.

Repairs and Maintenance

a) Plant and Machinery

18

Sno. Particulars Total

Expenses as

per Audited

Financial

Accounts

Utilities

(separately

for each)

Production

Cost Centres

(specify

separately)

1

Packing Cost

Centres (specify

primary or

secondary

separately)

2

Factory

Overheads

Administration

Overheads

Marketing or

Selling and

Distribution

Other

Activities

Non Cost

Expenses

b) Buildings

c) Others

8. Other Direct Expenses (specify)

9. Rent

10. Insurance

11. Rates and Taxes

12. Payment To Auditors

13. Traveling and Conveyance

14. Communication Expenses

15. Printing and Stationery

16. Bank Charges

17. Security Force Expenses

18. Sales Promotion Expenses

19. Handling Expenses

20. Miscellaneous Expenses

21. Transportation Charges

22. Quality Control

23. Royalty or Technical Know

24. Technical Assistant Fees

25. Other Statutory Levies

26. Lease Rent

27. Research and Development

28. Packing Expenses

29. Borrowing Charges

30. Loss on Assets Sold, Lost or Written Off

how

19

Sno. Particulars Total

Expenses as

per Audited

Financial

Accounts

Utilities

(separately

for each)

Production

Cost Centres

(specify

separately)

1

Packing Cost

Centres (specify

primary or

secondary

separately)

2

Factory

Overheads

Administration

Overheads

Marketing or

Selling and

Distribution

Other

Activities

Non Cost

Expenses

31. Exchange Rate Fluctuations

32. Provision For Doubtful Debts, Advances,

Claims and Obsolescence

33. Provision for Contingencies

34. Depreciation or Depletion

35.

Total Expenses

36.

Allocation of Utilities (specify)

37.

Apportionment of Overheads (specify

38.

Total

39.

Components

Less, Cost of Materials and Bought Out

40.

Conversion Cost (3839)

41.

Hour

Cost per Machine Hour or Direct Labour

42.

Current Year

43.

Previous Year

1. Specify cost centres as Weighing and Mixing, Filtration, Tablet Making, Preparation, Inspection, Testing, Quality Control etc under Production cost centres, as applicable.

2. Packing cost centres to be shown separately under Cartooning, Boxing, etc. under Primary or Secondary Packing cost centres.

20

Reconciliation Control:

Sno. Particulars Total

Expenses as

per Audited

Financial

Accounts

Utilities

(separately

for each)

Production

Cost Centres

(specify

separately)

Packing Cost

Centres

(specify

primary or

secondary

separately

Factory

Overheads

Administration

Overheads

Marketing or

Selling and

Distribution

Other

Activities

Non Cost

Expenses

1. Total Expenses b/f as per Sno. 35 above

2. Add, Opening Stock in Process

Less, Closing Stock in Process

3. Less, Credit for Recoveries

4. Less, Self Consumption, if any,

5. Add, Opening Stock – Finished

Less, Closing Stock – Finished

6.

Total (excluding Excise Duty)

7. Excise Duty Paid

8.

Total (including Excise Duty)

9.

Duty

Total Sales Realization (excluding Excise

10. Excise Duty Recovered

11.

Total Sales (including Excise Duty)

12. Add: Export Benefit, if any

13.

Profit as per Profit and Loss Account

21

PROFORMA ‘F’

Statement showing Apportionment of Conversion Cost and Packing Cost for various Products

Name of the Company

Name and address of the Factory

Drug Licence No. and Date

For the period

Sno. Product or Formulation

(specify)

Size Qty Total Cost Centres

as Weighing & Mixing, Filtration, Tablet Making,

Preparation, Inspection, Testing, Quality Control

etc. in columns below)

(Specify Names of cost centres such

Total Cost Centres

as Weighing & Mixing, Filtration, Tablet Making,

Preparation, Inspection, Testing, Quality Control

etc. in columns below)

(Specify Names of cost centres such

1 2 3 4 5 6 7 8 9 10 11 12 13 14

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

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

Apportionment of A. Conversion Cost to Product or Formulations B. Packing Cost to Product or Formulations

1

2

3

4

4

6

Etc.

Total

X = Actual direct labour or machine hours utilized as per actual recording or any other appropriate basis of apportionment.

Y = Conversion Cost in rupees

22

PROFORMA ‘G’

Statement showing Cost of Production, Cost of Sales, Sales Realization and Margin in

respect of Formulation

Name of the Company

Name and address of the Factory

Drug Licence No. and Date

Name of the Formulation/Drug

For the period

Sno. Particulars

1 Name of the formulation (with trade mark) manufactured or marketed and its composition

2 Type of Formulations: Plain or Coated Tablet, Soft or Hard or Printed Capsules with or without

Band, Sterile or Non sterile Liquid Powder or Ointment or Cream etc. (specify)

3 Type of Packing: Aluminum or Paper or Cellophane or Blister or Stripe or Vials or Ampoule or

Bottle or Tin or Jar etc. (specify)

4 Size of Packing (specify)

5 Batch Size (Specify)

Standard Actual

6

Year

Previous

Year

Current

Year

Previous

Year

Production Current

I No. of Batches Charged

II No. of Batches Produced

III Total Quantity Produced

IV Quantity Packed

V Packed Quantity Sold

(a) Quantity Sold in each pack size

(b) Total number of Packs Sold

VI Assessable Value of the product reconciled with

Excise Records

Quantity Sno. Particulars Unit Rate Amount Cost Per unit

Theoretical

Actual Rs. Rs. Current

Year

Previous

Year

A Materials Consumed

(a) Imported (specify input)

(b) Indigenous (specify inputs)

(c) Own Produced or Manufactured

(Specify major items)

(d) Less : Wastes or Rejects

(e)

B Primary Packing Material

Total Material Cost (A)

(a) Aluminum or PVC or Cellophane,

Blister Foil etc. for front use

(b) Aluminum or PVC or Cellophane,

Blister Foil etc. for back side

(c) Bottle or Container or Tube etc

(d) Ampoules/Vials etc

(e) Capsules etc.

(f) Leaflets

(g) Cartons

(h) Others (specify)

(i) Less : Wastes or Rejects

(j)

C Conversion Cost

Total Packing Materials (B)

23

Sno. Particulars Unit Quantity Rate Amount Cost Per unit

Theoretical

Actual Rs. Rs. Current

Year

Previous

Year

(a) Weighing and Mixing

(b) Filtration

(c) Preparation of Solution or

Ointment

(d) Inspection

(e) Quality Control

(f) Testing

(g) Research and Development

(h) Others (specify)

(i)

D Packing Cost (D)

E Other Expenses

Total Conversion Cost (C)

(a) Royalty

(b) Storage

(c) Others (specify)

(d)

F Total Cost (A+B+C+D+E)

G Add: Opening Work

Less: Closing Work

H Adjustment for Cost Variance

I Total Production Cost (F to H)

J Secondary Packing Materials

Total (E)inProgressinProgress

(a) Cartoons

(b) Leaflets

(c) Dropper

(d) Boxes

(e) Gum Tapes

(f) Others (specify)

(g) Less : Wastes or Rejects

(h)

K Secondary Packing Cost or

Charges

Total (a to g)

(a) Cartooning

(b) Boxing

(c) Others (specify)

(d)

L Total Cost of Packed Production

(I+J+K)

M

Sample or Trails etc.

Total (a to c)Less: Transfer for Clinical or

N Balance (L+M)

O

Less: Closing Stock – Packed

Add: Opening Stock – Packed

P Balance Sold

Q Administration Overheads

R Cost of Goods Sold (P+Q)

(a) Domestic Sales

(b) Export Sales

(c) Total (a+b)

S

1 Distribution Cost (specify)

a)

b)

c) etc

24

Sno. Particulars Unit Quantity Rate Amount Cost Per unit

Theoretical

Actual Rs. Rs. Current

Year

Previous

Year

S

2 Sales Promotion Expenses

(a) Wholesalers

(b) C and F Agents

(c) Retailers

(d) Others (specify)

S

3 Trade Commission

(a) Wholesalers

(b) C and F Agents

(c) Retailers

(d) Others (specify)

T Total (R+S1+S2+S3)

U

Interest and Financing Charges

V

included in Cost (give details)

Other Expenses or Income not

W

Excise Duty

Total Cost of Sales excluding

X

Excise Duty

(a)

(b)

(c)

Domestic Sales

Export Sales

Add: Export Benefits and

Incentives

(d)

Y

Net Sales Realization excludingTotal (a to c)Margin( NM)

Z

Excise Duty

1 Maximum Retail Price excluding

Z

applicable

2 Maximum Price under DPCO as

Z

3 Assessable Value of the Product

Z

4 Excise Duty

25

Proforma ‘H’

Statement showing Activity

Activities

wise Capital Cost of Plant and Machinery/Equipment relating to Bulk Drugs, Formulations and Other Common Services &

Name of the company:

For the Period:

(Amount in Rupees)

Sno. Particulars Gross Block Depreciation Net Block

Cost as at

beginning

of the year

Additions or

Transfers

during the

year

Deductions

or Transfer

during the

year

Total Cost

at the end

of the year

As at

beginning

of the year

For the year On

deductions

during the

year

Total at the

end of the

year

As at

beginning

of the year

As at the

end of the

year

A. Ingredients (specify)

1.

2.

etc

B. Bulk Drug Activity (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. Grand Total (A to G)

26

PROFORMA ‘I’

Statement of Profit Reconciliation (for the company as a whole)

Name of the Company

Drug Licence No. and Date

For the period

Sno. Particulars Current Year Previous Year

Rs. Rs.

1. Profit or Loss as per Cost Accounting Records

a) For Product Groups under these Rules

b) For the Product Groups outside these Rules

2. Add: Incomes not considered in cost accounts:

(a) Specify

(b)

Total

3. Less: Expenses not considered in cost accounts:

(a) Specify

(b)

Total

4. Add: Overvaluation of Closing Stock in Financial Accounts

5. Add: Undervaluation of Opening Stock in Financial Accounts

6. Less: Undervaluation of Closing Stock in Financial Accounts

7. Less:: Overvaluation of Opening Stock in Financial Accounts

8. Adjustments for others, if any (specify

9. Profit or Loss as per Financial Accounts

NOTES

1 Separate cost statement shall be prepared for each utility or each activity or sub

or inter

Formulations in the prescribed proforma. In case Intermediates or Bulk Drugs or

Formulations are processed through outside agency on job charges basis, separate cost

statement shall be prepared in the prescribed proforma indicating job processing

charges separately.

2 In case the company follows a pre

statement shall reflect figures at actual after adjustment of variances, if any. Reasons

for variations between standards and actual shall be clearly recorded. This information

is to be indicated for two years. Circumstances leading to revision of standards, if any

shall also be indicated in the form of a foot note.

3 If the drug is manufactured by fermentation process the following information shall be

:activityunit and intercompany transfers relating to Intermediates or Bulk Drugs ordetermined or standard costing system, the cost

27

maintained on annual average basis:

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

fermentation hours and turnaround time;

(b) average whole broth volume, whole broth potency and filtered broth potency per

batch;

(c) stage

from the fermented broth;

(d) average batch output and number of batches processed and drained;

(e) average potency/purity of the finished drug; and

(f) stage

including solvents usage shall be maintained along with quantity produced at each

stage. Similarly details of consumption of primary utilities of in respect of the drug

shall be maintained.

4 If the drug is manufactured by chemical process, the following details shall also be

maintained, namely:

wise and overall percentage recovery efficiency of both drug and intermediatewise annual average quantity consumption of all major raw materials

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

designed capacity, number of equipments available, position or code number of the

equipment, reaction or operation carried out in the equipment, batch size (input or

batch and output or batch), occupancy time hour, yield and WIW with respect to

main input at each stage and the cumulative yield, by

solvents etc. (Kg. or Ltr.).

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

data shall be maintained for such item and allocation of time at each equipment

alongwith basis of allocation.

5 Appropriate chemical equation of reaction with molecular weight and recovery levels of

solvents and by

in the process of technology and the consequential benefit there from during the year

or in the recent past shall be maintained.

6 Actual quantity consumed including overages, if any should be included in Proforma ‘G’.

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

reflected Keeping in mind the materiality of the item of cost in the product.

8 Separate proforma shall be prepared for the quantity sold within the country and the

quantity exported. Expenses incurred on export and the incentive earned thereon shall

be indicated in the proforma applicable for the quantity produced and exported. The

value of export incentives and other benefits received on exports shall be included in

sales realization. Separate cost details shall be maintained for expenditure incurred for

getting accreditation from overseas regulatory authorities and its recurring expenditure

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

product or recoveries ofproduct at each stage shall also be kept. Further, in case of any change

28

equitable basis.

9 Sales realizations shall be separately indicated for the quantities of product under

reference sold (i) at the notified prices under Drug (Prices Control) Order, 1995 and (ii)

at prices fixed by the company.

10 The quantitative basis of apportionment of common overheads should be enclosed

separately.

11 The items of cost shown in the proforma are indicative and the same shall be reflected

keeping in mind the materiality of the item of cost in the product and activity group.

12 Details of apportionment of depreciation to respective activity shall be specified

separately for common fixed assets.

13 The conversion cost shall be indicated cost center

capsules, syrups, injectables, ointment etc in relevant proforma.

14 Liabilities, if any, of overcharging on account of selling at a price higher than the price

fixed by the Government shall be furnished.

15 The packing cost shall be indicated cost center

capsules, syrups, injectables, ointment etc.

16 The abnormal Loss, if any, both in quantity and cost shall be shown in a separate

statement indicating the reasons and per unit impact thereof.

17 All items of income and expenditures in Proforma ‘I’ shall be reconciled with the

financial accounts for the relevant period.

[F. No. 52/7/CAB

B.B.GOYAL

Adviser (Cost)

wise separately in respect of tablets,wise separately in respect of tablets,2011]