About Pharmaceutical Industries In India

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 License / Small Scale Industry Registration / Industrial Entrepreneur Memorandum acknowledgement (copy to be enclosed).
8. Date of Commencement of Production.
9. Type of formulation:-
(i) Type[Plain/Coated Tablets. Multi-layered sustained release / Soft / Hard / Printed capsules (without / with / sealing band) / sterile / non-sterile Liquid / Powder
/Ointment / Cream etc.];
(ii)In case of Tablets please furnish average weight of 100 Tablets;
(iii)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/ 10ml / etc.; 5gms/ 10gms/ etc.].
12. Number of packs sold during the last accounting year and details of other packs of the same formulation with their retail prices.

13. Break-up of Retail Price:-

Details

Existing Price if any* (Rs./Pack)

Now Claimed(Rs./Pack)

1. Material cost (as per s.no.14 d):
2. Conversion Cost (as per norms);
3. Packing material costs (as per s.no.15 or as per norms)
4. Packing charges;
5. Ex-factory cost (a to d);
6. MAPE 100% on (e) above;
7. Excise Duty;
8. Retail Price (R.P.)(e+f+g).

*Existing retail price approval letter no. and date- copy to be enclosed.

14. Material Cost:-
a.    Batch size (nos./litres/kgs./etc.)
b.    No. of packs that can be theoretically obtained from the   batch size as in (a) above
c.    Material cost for the batch size as in (a) above

S. No	Name of the Material	Unit	Theoretical Quantity	Actual Overages	Total Quantity (4+5)	Rate/Unit	Cost for the Batch (6x7)
1	2	3	4	5	6	7	8

Imported
1.
2.
3.
etc.
Indigenous
1.
2.
3.
etc.
Total.....................;
Add; Process loss as per norms..........%
Total Material Cost….................;
                                           Total Material Cost
Material Cost per pack = ____________________
                                         Theoretical No. of Packs
15. Packing Material Costs:-
Packs of .....................
Batch Size:...........Tablets/Gms/etc/ each

S.No.	Name of the Packing Material	Unit	Rate per Unit (Rs.)	Qty.Required per batch	Value of Packing Materials/Batch (Nos/Kgs etc)(Rs.)
1	2	3	4	5	6

Imported
1.
2.
3.
etc.
Indigenous
1.
2.
3.
etc.
Total........................................................
Add. Process loss as per norms.............%
Total Packing Material Cost.....................
                                                    Total packing material cost
Packing Material cost per pack= ______________________
                                                   No. of packs 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:-

1. A statement indicating the purchases made during the last three months with copies of invoices certified by cost accountant/chartered accountant shall be enclosed.
2. 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

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The information furnished  is correct and true to the best of my knowledge and belief.

Authorised Signatory:

Place :           Name :
Date :            Designation :