PROCEDURE FOR ISSUE OF MANUFACTURING LICENSES / BLOOD BANKS & APPROVAL OF PRIVATE TESTING LABORATORY/PROCESS


The Applicant has to submit the application in the prescribed format before the Licensing Authority in the office of the Controller, Food & Drugs Administration, Idgah hills, Bhopal.

The concerned Senior Inspector  is directed to inspect the premises and submit the report.

Upon receipt of the report and it's scrutiny either the license   is granted or the application is rejected as the case may be.

The licensee may apply for endorsement of additional items in the licenses which are sanctioned after due scrutiny.

For approval of the Testing Laboratories to permit them to carry out test / analysis on behalf of the manufacturers, a joint inspection is carried out  by the State and the Central Govt. Drugs Inspectors .

The licenses of Blood Banks, Blood components & Blood Products large volume Parenterals, Sera and Vaccines are issued by the State Licensing Authority only after their approval by the Central License Approving Authority i.e. The Drugs Controller General India New Delhi. For such licences joint inspection of the premises is carried out by the officer of the State Drug Control and Central Drugs Standard Control Organization.


PROCESS
FOR GRANT OF VARIOUS DRUGS MANUFACTURING LICENCES 

S.No Activity Where to apply Steps Time Period
1 2 3 4 5
1 Grant of Manufacturing Licence in Form 25 25 -A 25-B 25-F 28 28-A 28-B Licensing Authority of the office of Food & Drugs Administration Idgah Hills Bhopal In Form 24 24-A 24-B 24-F 27 27- A 27-B (A) Issue of letter to inspector for submitting inspection report (B) Inspection and submission of report by inspector (C) Scrutiny of inspection report & decision about grant or refusal (If the proposed Chemists are approved ) (D) Scrutiny of inspection report & decision about grant or refusal (If the proposed Chemists are not approved ) (A) 7 Days (B) 30 Days (C) 30 Days (D) Maximum 60 Days
2 Grant of Cosmetics Manufacturing Licence in Form 32 32- A Licensing Authority of the office of Food & Drugs Administration Idgah Hills, Bhopal in Form 31 31-A As per (A),(B),(C),(D) above As per (A),(B),(C),(D) above
3 Grant of Homoeopathic Medicines Manufacturing Licence in Form 25-C Licensing Authority of the office of Food & Drug Administration Idgah Hills Bhopal in Form 24-C As per (A), (B),(C)&,(D) above As per (A),(B),(C),(D) above
4        
5 Grant of Licence for the purpose of Test Examination Or Analysis in Form 29 Licensing Authority of the office of Food & Drugs Administration Idgah Hills Bhopal in Form 30 Scrutiny of application & decision about grant of Licence or refusal 15 Days
6 Grant of Manufacturing Licence due to change of Constitution Licensing Authority of the office of Food & Drugs Administration Idgah Hills Bhopal Scrutiny of application & decision about grant of Licence or refusal 21 Days

PROCESS OF GRANT OF LICENCES WHERE JOINT INSPECTION WITH CENTRAL GOVERNMENT OFFICERS AND FINAL APPROVAL DRUGS CONTROLLER GENERAL INDIA IS REQUIRED

S.No Activity Where to apply STEPS Time Period
1 2 3 4 5
1 Approval of Testing Laboratory in Form 37  Licensing Authority of the office of Food & Drugs Administration Idgah Hills Bhopal in Form 36 (A) Issue of letter of joint inspection by the inspector of State Govt.with inspector of Central Govt. (B) To complete process of joint inspection (C) Scrutiny of joint inspection report& decision about issue of Approval or refusal (If proposed Chemists are approved) (D) Scrutiny of joint inspection report& decision about issue of Approval or refusal (If proposed Chemists are not approved) A) 7 Days (B) Max. 3 Months (C )Max.30 Days (D)Max. 60 Days
2 3 Manufacturing Licence for Large Volume Preparations,Sera & Vaccines in Form 28- D Blood Banks Form 28-C Licensing Authority of the office of Food & Drugs Administration Idgah Hills Bhopal in Form 27-D Licensing Authority of the office of Food & Drugs Administration Idgah Hills Bhopal in Form 27 -C (A) & (B) as above (C) Scrutiny of joint inspection report and decision about preparing Licence and sending it to the D.C.G.I. New Delhi for approval or refusal (if proposed Chemists are approved) (D)Scrutiny of joint inspection report and decision about preparing Licence and sending it to D.C.G.I.New Delhi for approval (If the proposed Chemists are not approved ) (E)Issue of Licence received duly approved from D.C.G.I.New Delhi. (A) (B) (C) & (E) Above (A) & (B) as above (c )Max. 15 Days (D)Max.#0 Days (E) 7 Days (A) 7Days (B) Max. 3 Months ( C)Max. 15 Days (E) 7 Days

 

PROCESS FOR APPROVAL OF MANUFACTURING -ANALYTICAL CHEMIST

S.NO. Activity Whom to apply Steps Time Period
1 2 3 4 5
1 Approval as manufacturing Chemist The senior drug Inspector  Or Licensing Authority of the Office of the Controller Food & Drugs Administration Bhopal (A) Inspection after receipt of Application (B)Scrutiny of report of inspector and call for professional Competency evaluation (C) Grant of approval as refusal after PCE Test

Max 30 Days --"--
7 days

2 Approval as analytical Chemist

--"--

As at [A] [B] [C] above As at [A] [B] [C]

 

PROCESS FOR INCLUSION OF ITEMS IN LICENCE

S.NO. Activity Whom to apply Steps Time Period
1 2 3 4 5

1. . 2

. Inclusion of items in Drugs Mfg. licence. Licensing Authority of the office of Food & Drugs Administration Idgah Hills Bhopal Licensing Authority of the office of Food & Drugs Administration Idgah Hills Bhopal --2--   Scrutiny of application & decision to grant or refuse 15 days 

 

RENEWAL OF DRUG LICENCES

S.NO. Activity Whom to apply Steps Time Period
1 2 3 4 5
1. Renewal of manufacturing Licence Licensing Authority of the office of Food & Drugs Administration Idgah Hills Bhopal Scrutiny of application on receipt of requisite documents Max 3 Month
2. Renewal of Manufacturing Licence, Blood Banks, Large Volume Parenterals Sera-vaccines and approved testing Laboratories Licensing Authority of the office of Food & Drugs Administration Idgah Hills Bhopal . Issue of letter for joint inspection by the inspector of State Govt.with inspector of Central Govt. B)To complete process of joint inspection ( C) Scrutiny of joint inspection report& decision about issue of renewal (D)Preparation of renewal Certificate And to send it to DCGI New Delhi/ Dy. DCI Mumbai for approval and signature (E) Issue renewal Certificate 7 days 3 month 15 days 7 days 7 Days
         

 

ISSUE OF VARIOUS CERTIFICATES 

S.NO. Activity Whom to apply Steps Time Period
1 2 3 4 5
1. Issue of WHO . G.M.P.Certificate Licensing Authority of the office of Food & Drugs Administration Idgah Hills Bhopal [A] To issue letter for joint inspection by the inspector of this Admn. with office of by Dy. D.C. (I) Mumbai [B] Joint inspection [C] Scrutiny of report and issue or refusal 7 days 3 month 15 days
2. Issue of non conviction Certificate --do-- Scrutiny of application & grant or refusal 3 days
3. Issue of Performance Certificate --do-- --do-- 2 days
4. Issue of good Manufacturing Practices (GMP) Certificate --do-- --do-- 3 days
5. Issue of validity Certificate (i) do (ii) S.D.I. of the area

--do--

2 days


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