Different forms are prescribed for issuance of licence according to the nature of drugs.

1) Applications in prescribed form duly filled in and signed.

2) Challan of Rupees as prescribed to be paid under correct head of account.

3) Copy of approved plan.

4) Copy of wholesale licences.

5) List of products.

6) Draft Labels.

7) Manufacturing Process.

8) Stability Data.

9) Method of Analysis.

10) Manufacturing Process.

11) Flow Sheet.

12) Standard Operating Procedures for each product.

13) Master Card formula.

14) Consent letter of approved public laboratories.

15) Authority letter in favour of a person to represent the company.

16) Copy of Memorandum and Articles of Association/Partnership Deed.

17) Appointment letter, Consent letter, copy of approval letter, copy of degree

18) Additional information form for each products.

19) Additional information form showing the details of the company.

20) Computer application form A & B.

21) Prescribed undertakings duly signed.

22) List of Directors/Partners.

The application duly received would be scrutinised by the concerned officer and point out any irregularities or the documents left out.  After the compliance properly, an inspection of the firm’s premises will be carried out by the Senior Officers and on the basis of the recommendation of the Senior Officers, the application  would be considered for grant of licences accordingly.

In case of Large Volume Parenteral products and Blood and Blood Components, Joint inspection would be carried out by the Officers of Deputy Drugs Controller, West Zone, Mumbai and the Officers of this Administration.  On recommendation of the above officers, the Licences duly prepared would be signed  by the State Licensing Authority and send the same to the Central Licence Approving Authority for counter signature.