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Granting & renewal of Drug Manufacturing License

General Instructions

All applications for Grant & renewal of Drug Manufacturing License from eligible applicants are received by the Drug Controller (DC). The DC scrutinizes the application and inspects the proposed manufacturing premises. If the documents submitted by the applicant are in order and inspection report is satisfactory, the application is forwarded to the Licensing Authority for issuance.

Fields marked with ‘*’ are mandatory and should be filled in before submitting the form on the single window portal. Leaving fields blank in the Form is not allowed. In case applicants wish not to enter data in a field, they can put “NA” if it is a text/description field or a “0”, if it is a numeric field. In case of errors, the form will show an error message. The applicant may correct the data and save the form again.

Some of the fields can accept multiple values. If the applicant wishes to furnish more than one item, he may use the “+” button to add more rows. Similarly, if he wishes to remove a row, he may use “x” button.

Applicants can attach documents in digital format as documentary evidences which the department will use for verification and issuance of the license. Clicking on the ‘Choose’ button will allow them to select documents to be uploaded. Before submitting the application, applicants need to ensure that all the information furnished by them is satisfactory and correct to the best of their knowledge and understanding. The application can be submitted by clicking on the ‘Submit’ button.

After the form is successfully submitted, applicants can pay the required license fees online. Upon processing of payment by the bank, an SMS & Email notification with the application number is sent to the applicant on the registered mobile number and email address. The application number will be used for tracking the application online.

 

Checklist of Documents

1.       Proof of Identity of the applicants (Copy of Passport/Aadhar Card/Driving License)

2.      Constitution of Firm (Proprietorship/Partnership/Pvt. Ltd./Public Ltd./Registered Society/Govt. Agency)

3.      Registered Partnership Deed under I.G.R. Odisha/Articles of Association/ Memorandum of Association as per the Companies Act, 2013.

4.      Resolution Copy passed by the Board of Directors for obtaining of License. In case of Govt. Agencies, Legal Authorization from Competent Higher Authority

5.      Power of Attorney/Letter of Authorization (wherever applicable)

6.      Detailed list of manufacturing and analytical equipment with copies of the purchase bill

7.      Copy of the Site Master File (SMF)

8.      List of Standard Operating Procedures (SOPs)

9.      Calibration Validation certificate of Equipment (wherever necessary)

10.   List of drugs intended to be manufactured including formula, pack size and details of primary packing material, literature and insert (if any) draft label of product intended to be manufactured

11.    Layout plan of the premises (blue print along with details of area of each section duly signed by applicant and owner of the house)

12.   Design and lout of HVAC systems if application (validation thereof)

13.   Documentary Evidence in support of Ownership & Building

14.   House Rent Agreement in case of Tenancy or declaration of House Owner if same as applicant for the specific purpose

15.   Educational Certificate of the persons in-charge of Manufacturing, Testing and Quality Assurance

16.   Consent Letter of persons in-charge of Manufacturing, Testing and Quality Assurance for their specific jobs

17.   Experience Certificate of the persons in-charge of Manufacturing, Testing and Quality Assurance from their respective ex-employers

18.   Declaration/Affidavit of their persons in-charge of Manufacturing, Testing and Quality Assurance regarding their non-engagement elsewhere & their previous engagements in the concerned fields

19.   Line Diagram of the Air Handling Unit (AHU)/AC/De-Humidifier/Purified Water Supply/Portable Water Supply/Drainage/Return Air Vent, etc.

20.  Fire Safety measures provided, no. of fire extinguishers provided with their validity and other steps taken for safety

21.   Provisions made for disposal of Waste Water Management

22.  Pollution Control Certificate (wherever applicable)

23.  Consent Letter from an Approved Institution to carry out Tests & Analysis of Manufacturing Drugs and Raw Materials prior to release of the batch along with the copy of Valid License/thereof where the application had not provided own Testing facilities (which require sophisticated instruments)

24.  Fire Safety Certificate obtained from Fire Officer

25.  Compliance of Schedule M, M-I, M-II, M-III (as the case maybe)

26.  Protocol for testing in case of Patent & Proprietary medicine (wherever necessary)

27.  Stability studies data of drugs (Stability studies for all products is to be submitted in case of renewal of license. In case of grant of license only established pharmacopoeia products will be allowed. However, real time/accelerated studies has to be commenced immediately after the products are manufactured)

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

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

30.  Technical Data in respect of the products for manufacture of drugs:

(a)  Technical Documents to be submitted for Bulk Drugs:

(i)                Manufacturing procedure of each product

(ii)               Flow chart with structural formula of reactions as per the Master Formula record and analytical procedure of each applied product with mode of procurement of official reference standards or working standards

(iii)            Official Monograph copies

(iv)            Consumption coefficients generated and their treatment followed

(v)             Specimen labels of all applied products

(b)  Technical Documents to be submitted for Formulation:

(i)                Consolidated list of Formulation with packing particulars separately category-wise, viz. Tablets, Capsules, Injectables, etc.

(ii)              Details of biopharmaceutical classification of each drug to be manufactured (Oral Dosage form) with result of bioequivalence study of drug (Oral Dosage form under category II & IV)

(iii)            Manufacturing & Analytical procedure of each product (not required in case of renewal)

(iv)            Specimen labels

(v)              Labels of the similar products moving in the market for formulation not included in the IP

(vi)             Copies of monographs of drugs which are not included in IP

 

Timeline

Drug Manufacturing License & its renewal is provided within 90 working days from the date of submission of application. The department can however, raise queries on the application within 7 working days of receipt of application.

 

Fee Structure :

Sl No

Category

Application Forms

License Forms

Fees for Grant

Retention Fees before expiry

Retention Fees after expiry but within 6 months (P.M)

Fees for Duplicate Copy

Additional item(drug)

Remarks

1

Other than C & C1

24

25

Rs 6000 +

Rs 1500(Inspection Fees)

Rs 6000

Retention Fees along with late fees calculated @ 2%

Rs 1000

Add items Rs 300

Licence is for 10 items of each  category of Sch M & M-III

2

Schedule C,C1( Excluding Part X B & Schedule X) 

27

28

Rs 6000 +

Rs 1500(Inspection Fees)

Rs 6000

Retention Fees along with late fees calculated @ 2%

Rs 1000

Add items Rs 300

Licence is for 10 items of each  category of Sch M & M-III

3

Schedule C, C1 & X

27-B

28-B

Rs 6000 +

Rs 1500(Inspection Fees)

Rs 6000

Retention Fees along with late fees calculated @ 2%

Rs 1000

Add items Rs 300

Licence is for 10 items of each  category of Sch M & M-III

4

Schedule X (Other than C & C1)

24-F

25-F

Rs 6000 +

Rs 1500(Inspection Fees)

Rs 6000

Retention Fees along with late fees calculated @ 2%

Rs 1000

Add items Rs 300

Licence is for 10 items of each  category of Sch M

5

Loan Licence (Other than C & C1)

24-A

25-A

Rs 6000 +

Rs 1500(Inspection Fees)

Rs 6000

Retention Fees along with late fees calculated @ 2%

Rs 1000

Add items Rs 300

Licence is for 10 items of each  category of Sch M & M-III

6

Loan Licence for C & C1 excluding Part Sch X-B & Sch X )

27-A

28-A

Rs 6000 +

Rs 1500(Inspection Fees)

Rs 6000

Retention Fees along with late fees calculated @ 2%

Rs 1000

Add items Rs 300

Licence is for 10 items of each  category of Sch M & M-III

7

Repacking Licence (Other than C & C1 excluding Sch. X)

24-B

25-B

Rs 500 + Rs 200 (Inspection Fees)

Rs 500

Retention Fees along with late fees calculated @ 2%

Rs 1000

Add items

Rs 100

Licence is for 10 items of each category of Sch M

8

L.V.P Sera & Vaccine

27-D

28-D

Rs 6000 +

Rs 1500(Inspection Fees)

Rs 6000

Retention Fees along with late fees calculated @ 2%

Rs 1000

Add items Rs 300

Licence is for 10 items of each  category of Sch M


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