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Requirements for Grant or Renewal of Manufacturing License (to be applied in Single desk Portal of Dept. of Industries)

 

A.DOCUMENTS TO BE SUBMITTED TO THE LICENSING AUTHORITY ,DRUGS CONTROL ADMINISTRATION BY THE APPLICANT FOR GRANT/ RENEWAL OF LICENCES IN FORM-25, 28, 32 AND 36

 

1.     Covering Letter   (Introduction of applicant with address of the Plant and Administration office and his requirement)

2.     Application (statutory) in Form- 24 with fee – Rs.7500/n or
                                    Form-27 with fee  - Rs.7500/- or
                                    Form-31 with fee – Rs.3500/- or
                                   Form-36 with fee – Rs.7500/-  duly signed by the Proprietor / Managing Partner / Managing Director/ Person declared as responsible under Sec.34 / Person Authorized by the Board of Directors accompanied by Company Board Resolution.

3.     Challan in original remitting the required amount of fee in the Head of Account         

0210    – Medical and Public Health
04        - Public Health,
104      – Fees, Fines etc

4.     Attested copies of partnership Deed / Memorandum and Articles of Association (Notarized)

5.     Declaration of the Proprietor / Partners / Directors etc. in Affidavit  (Notarized) (Format enclosed)

6.     Attested Copy of Ration Card or Passport or Electoral Card / Bank Account Details in support of proof of residential address of the responsible person.

7.     Attested copies of Rent / Lease deed in case of Rental premises

8.     Declaration of the owner of the premises if premises owned by the applicant firm or company with the documentary evidence of ownership like Registered sale deed etc and or proof of allotment of the site and or building along with latest property tax receipt.

9.     Plan and layout of the premises showing the installation of Machinery and Equipment.   preferably a Blue Print approved by Licensed Engineer and signed by the applicant who signed in the statutory form.

10.  Design and layout of HVAC systems if applicable.

11.  Detailed list of Manufacturing and Analytical Equipment with copies of purchase Bills. (As per Format)

12.  Application for approval of Technical Staff in the prescribed format with enclosures of consent letter, copies of qualification certificates, experience certificates of proposed technical staff along with earlier approvals, if any, appointment order of the Technical staff. 

13.  Permission obtained from the Municipal Authorities/ Panchayat authorities / Certificate in conformity with Factories Act for construction and starting the Unit.

14.  Permission from the Health Authorities / Pollution Control Board clearance of the area for setting up the manufacturing facility.  In case of licence for manufacture of API the A.P.Pollution Control Board clearance for API is sought.

15.  Clearance from Drugs Controller General (India), New Delhi in case of new drugs (Either Bulk drug or Formulation) – New Drugs as defined under Rule 122 E of Drugs and Cosmetics Rules 1945.

16.  Site Master File. (Refer para 29 of part I of Schedule M)                                         

17.  Technical Data in respect of the products for manufacture of:

           

Technical Documents to be submitted for Bulk Drugs:

i.        Manufacturing procedure of each product

ii.        Flow Chart with structural Formula of reactions as per Master Formula record and analytical procedure of each applied product with mode of procurement of official reference standards or working standards.

iii.        Official Monographs copies

iv.        Consumption coefficients of Raw Materials.(as per Format)

v.        Details of effluents generated and their treatment followed.

vi.        Specimen labels of all applied products

 

Technical Documents to be submitted for Formulations

i.        Consolidated list of Formulations with packing particulars separately Category wise Viz. Tablets, Capsules, Injectables etc.

ii.        Manufacturing & Analytical procedure of each product.

iii.        Specimen labels

iv.        Labels of the similar products moving in the market for formulations not include in IP

v.        Declaration regarding the Brand Names of the Product.

vi.        Copies of monographs of drugs which are not included in IP

 

ADDITIONAL REQUIREMENTS IN CASE OF RENEWAL

1.     Drug Licence with list of products approved in the last licensing period.

2.     Consolidated List of the Products.

3.     Production particulars for the last Licensing Period (As per Format)

4.     Declaration regarding the changes in the premises, constitution, (Directors/ Partners), Technical Staff of the firm/ Company.

5.     Original labels.