FORM
I
FORM OF INFORMATION/APPLICATION
FOR FIXATION OR REVISION OF PRICES
OF SCHEDULED BULK DRUGS.
FORM
III
FORM OF APPLICATION
FOR APPROVAL OR REVISION OF PRICE
OF SCHEDULED FORMULATIONS.
FORM
IV
FORM OF APPLICATION
FOR APPROVAL OR REVISION OF PRICE
OF SCHEDULED FORMULATIONS
IMPORTED IN FINISHED FORM.
FORM
I
(TO BE SUBMITTED IN DUPLICATE)
[ SEE PARAGRAPHS 2, 3 AND 4 ]
FORM
OF INFORMATION/APPLICATION
FOR FIXATION OR REVISION OF PRICES
OF SCHEDULED BULK DRUGS.
1. Name of the Bulk
Drug.
2. Name of the manufacturer.
3. Address of the
Registered/Head Office of the
Manufacturer.
4. Address of the
Factory.
5. Capacity under
Industrial Licence/Small Scale
Industry Registration/Industrial
Entrepreneure Memorandum acknowledgement:-
- No. and date of Industrial Licence/Small
Scale Industry Registration/Industrial
Entrepreneure Memorandum acknowledgement;
- Production Capacity (Tonnes/Kgs./Litres
etc.).
6. Installed Capacity:-
Number of shifts per day;
Number of operating days per year;
Maximum production per shift (Tonnes/Kgs./Litres
etc.);
Date of commissioning;
Annual installed capacity.
7. Date of Commencement
of Commercial Production.
8. Actual production
achieved during the last accounting
year (preferably monthwise) and
also monthly production during
the current year (Tonnes/Kgs/Litres
etc.).
9. Brief note on
the manufacturing process adopted
by you indicating all stages including
recovery of by-products, if any,
solvents etc. and sagewise overall
yield for each bulk drug.
10. Average hourly
rate of production for each of
the bulk drug since the commencement
of the commercial production.
11. Maximum hourly
rate of production achievable.
12. Estimated production
of the bulk drug during the next
three years.
13. If the production
is proposed to be captively consumed
for manufacturer of the formulation,
please furnish the quantity to
be so consumed out of the production
given against Serial No.8 and
Serial No.12.
14. Capital employed
for the manufacture of the bulk
drug(s):-
Net fixed assets;
Working Capital;
Total.
15. Please state
how the above capital employed
is financed by net worth and borrowings.
(In the case of
multi-purpose plant the capital
employed/net worth as above and
the share to be allocated to the
bulk drug/intermediate under consideration
to be given.)
16. Please state
the average rate of interest paid
by you on your borrowings, supported
by figures of the amount of loans,
average rate of interest etc.
as per latest audited Balance
Sheet.
17. Please furnish
latest c.i.f price of the bulk
drug if the same had been imported
or is being imported by you or
by any other agency known to you.
18. Please furnish
the cost of production of the
bulk drug as per Annexure to this
Form duly certified by a Practicing
Cost Accountant/Chartered Accountant.
19. Please furnish
number of persons employed/to
be employed, gradewise, and their
average monthly emoluments including
contribution on account of Provident
Fund etc.
20. Please furnish
the total amount of expenses under
each of the element of other conversion
costs viz. stores, factory and
administration overheads and depreciation
and the basis adopted for allocation
to the product in question.
21. If this item
is manufactured/to be manufactured
in a multi-product plant, the
method adopted for allocations
to individual drugs for common
expenses viz. process hours, equipment
hours etc. may be furnished.
22. PLEASE ALSO
FURNISH THE FOLLOWING:-
The types of packing
materials used and their average
rates;
Basis and calculations
of profit margin;
Photocopies of invoices
of raw materials having substantial
consumption and also for power,
fuel ofi etc.;
Details of the fixed
assets, method of depreciation,
rate of depreciation alongwith,
working capital required for the
product;
A copy each of Audit
& Balance Sheet and Profit
& Loss Account for the last
three years and in the case of
a company copies of the latest
Cost Audit Report & Annual
Report.
Notes :
Any hold up affecting
production to be shown clearly
against Serial No.8.
In case the same
plant facilities are used for
production of more than one product,
the information as per serial
No.6 may be given product wise.
ANNEXURES
(See Item No. 18
of the Form I of the First Schedule)
I. Name of the Bulk
Drug.
II. (a) Production
in Tonnes/Kgs. /litres etc.
(b) Sales In Tonnes/Kgs./litres
etc.
(c) Despatches In Tonnes/Kgs.
/litres etc.
III. Details of
Cost:-
(a) Period;
(b) Cost Data:
1. Raw Materials :-
(a) Imported
1.
2.
3. etc.
(b) Indigenous
1.
2.
3. etc.
Total raw materials
cost :
Less Recoveries of Solvents :
Net Raw Materials Cost :
2. Utilities:-
(a) Power
(b) Water
(c) Fuel (Oil/Coal)
(d) Others (To be specified)
Total Utilities Cost.
3. Conversion Cost:-
(a) Salaries and wages
(b) Operating supplies or consumable
stores
(c) Repairs and Maintenance
(d) Quality Assurance
(e) Effluent treatment Other factory
overheads
(f) Administration overheads
(h) Research and Development expenses
(i) Depreciation
Total Conversion Cost.
4. Cost of production
(1+2+3).
5. Interest on borrowings.
6. Minimum Bonus.
7. Total (4+5+6).
8. Packing:-
(a) Materials
(b) Other expenses
Total Packing Cost.
9. Selling Expenses.
10. Transport Charges.
11. Transit Insurance
Charges.
12. Non-Recoverable
Taxes.
(Please specify and submit details
alongwith supporting documents.)
13. Total cost of
sales.
14. Profit Margin.
(Basis of calculations be submitted)
15. Selling Price
(13+14)
16. Place notified
by the Govenunent, if any. (Please
give No. and date of Notification)
17. Actual sale
price, or Notional price, if used
captively.
NOTES:-
1. Items of expenses
to be excluded from costs
• Bonus in
excess of statutory minimum,
• Bad debts
and Provisions
• Donations
and charities
• Loss/Gain
on sale of assets
• Brokerage
and commission Expenses not recognised
by Income Tax authorities
• (Salary, perquisities,
advertisements etc.)
• Adjustments
relating to previous years.
2. In the case of
imported raw materials, please
furnish seperately the c. i. f.
price, duty of customs and other
charges totalling to the landed
cost adopted against 8. No. 1
(a).
3. Cost of intermediates
Manufactured for captive use should
be on the basis of factory cost
of production inclusive of administration
overheads and shown separately
against 8. No. 1(b). A separate
cost-sheet in the same proforma
may please be appended.
4. Cost of generated
utilities like power, steam etc.
should be separately given furnishing
the details of purchased utilities
consumed, rate and cost with other
expenses incurred on generation
with reference to S. No. 2 .
5. Details in respect
of factory overheads, administration
overheads and selling expenses
should be furnished against S.No.
3(d), 3(e) and 8.
6. The basis of
depreciation adopted in your financial
accounts may please be given against
S.No. 3(f).
7. Please indicate
clearly whether the existing price
is notified by the Government
or notional price against S. No.
16 and 17.
8. The information
furnished in this form is to be
certified by the Authorised Signatory
of the Company and by the cost
accountant/chartered accountant.
The information furnished above
is correct and true to the best
of my knowledge and belief.
Authorised Signatory:
Place :
Name :
Date :
Designation :
FORM
III
(TO BE SUBMITTED IN SEVEN COPIES)
(SEE PARAGRAPHS 2, 8, 9 AND 10)
FORM
OF APPLICATION
FOR APPROVAL OR REVISION OF PRICE
OF SCHEDULED FORMULATIONS.
1. Name of the Formulation.
2. Name of the Manufacturer.
3. Address of Registered/Head
Office/ Administrative Office.
4. Address of the
Factory.
5. Composition as
per label claim and approved by
Drug Control Authorities.
6. Drug Control
Authority Permission Number and
Date (copy to be enclosed).
7. Number and date
of Industrial Licence/Small Scale
Industry Registration/ Industrial
Entrepreneure Memorandum acknowledgement
(copy to be enclosed).
8. Date of Commencement
of Production.
9. Type of formulation:
-
• Type [Plain/ Coated Tablets,
Multi-layered sustained release/
Soft/ Hard/ Printed capsules (without/
with/ sealing band) / sterile/
non-sterile Liquid/ Powder/ Ointment/
Cream etc.];
• In case of Tablets please
furnish average weight of 100
Tablets;
• In case of Capsules please
furnish size of capsule.
10. Type of packing
[Aluminium/ Paper/ Cellophane/
Strips/ Blister/ Vials/ Ampoules/
White Colour Bottles/ Tins/ Jars/
with/ without dropper/ cutting
blades/ catch cover etc.].
11. Size of packs
[10's/ 100's/ etc; 1ml/ 2ml/ 10
ml/ etc.; 5 gms/ 10 gms/ etc.].,
12. Number of Packs
sold during the last accounting
year and details of other packs
of the same formulation with their
maximum retail prices.
13. Break-up of Maximum Retail
Price :- ) Maximum Retail Price
(M.R.P.) (e+f+g).
* Existing Retail
Price Approval Letter No. and
Date - copy to be enclosed.
14. Material Cost
• Batch Size (Nos./Litres/Kgs./etc);
• No. of packs that can
be theoretically obtained from
the batch size as in (a) above;
• Material Cost for the
batch size as in (a) above;
Total ...................................................
:
Add: Process loss as per norms
..............% :
Total Material Cost .................................
:
Material Cost per Pack = Total
Material Cost
Theoretical No. of Packs
15. Packing Material Costs:-
Packs of .......................................
Batch Size : .....................
Tablets/Gms/etc. each
Total ...................................................
:
Add: Process loss as per norms
..............% :
Total Packing Material Cost .................................
:
Packing Material Cost per Pack
=Total Packing Material Cost
No. of Packs as per Batch size
Note :
1. The information furnished in
this form is to be certified by
the authorised signatory of the
company and Cost Accountant/Chartered
Accountant.
2. In respect of bulk drug and
major raw materials the following
documents shall be enclosed :-
• A Statement indicating
the purchases made during the
last three months with copies
of invoices certified by Cost
Accountant/Chartered Accountant
shall be enclosed.
• Certified copies of recent
batch production records or, in
case production has not commenced,
other documents maintained under
Drugs and Cosmetics Act and the
Rules made thereunder, in support
of the quantities of raw materials
claimed.
3. The rates claimed shall be
net of modvat, wherever applicable.
4. Basis and calculation of excise
duty [S. No. 13(g)] to be given.
5. Basis and calculation of Sales
Tax and other local taxes [S.
No. 13(h) and S. No. 13(i)] to
be given.
The information furnished above
is correct and true to the best
of my knowledge and belief.
Authorised Signatory :
Place :
Date :
Name :
Designation :
FORM
IV
(TO BE SUBMITTED IN SEVEN COPIES)
(SEE PARAGRAPHS 2, 8, 9 AND 10)
FORM OF
APPLICATION
FOR APPROVAL OR REVISION OF PRICE
OF SCHEDULED FORMULATIONS
IMPORTED IN FINISHED FORM.
1. Name of the company.
2. Address of the
Registered/ Head Office/ Factory,
if any.
3. Reference to
Permission, if any, given by Drug
Control Authorities for import/
sale of the item.
4. Name of the imported
formulation/ therapeutic group.
5. Type of formulation
(capsule/ tablet/ inj. etc.).
6. Composition of
the formulation.
7. Type of Packs
(strip/ vial/ ampoule etc.).
8. Pack size (10's
etc/ 10 ml etc/ 5 gms etc.).
9. Country from
which imported and date of import.
10. (Quantity/ Number
of packs imported with Batch/
Lot Number.)
11. C.I.F. Value
in Foreign Currency.
(Not to include bank commission,
interest etc.)
Total (Rs.) Per Pack (Rs.)
12. C.I.F Value in Rs. actually
paid.
(Not to include bank commission,
interest etc.)
13. Duty of customs,
if any, actually paid.
14. Clearing Charges
(with details) actually incurred.
15. Landed cost
(12+13+14).
16. Packing Materials,
if any, as per norms.
(Applicable in case of repacking)
17. Packing Charges,
if any, as per norms.
18. Landed Cost
(including repacking cost, if
any). (15+16+17)
19. Margin @ 50%.
20. Duty of Excise,
if any.
21. Sales Tax /
Value Added Tax (VAT)
22. Other local
taxes, if any
23. Maximum Retail
price claimed (18+19+20+21+22).
24. Existing Maximum
retail price, if any :
(copy of approval letter to be
enclosed)
NOTES:-
• Information furnished
should be certified by the Authorised
Signatory of the company and a
Cost/ Chartered Accountant.
• In respect of SI. Nos.
11 to 14 and 16, the claims shall
be supported by certified copies
of documentary evidence.
The Information furnished above
is correct and true to the best
of my knowledge and belief.
Authorised Signatory:
Place :
Name:
Designation:
