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Blood Control Act

9.

 In schedule A of the said rules:-

(a)

 for form 26-G, the following Form shall be substituted, namely:-

Form 26-G

(See Rule 122-F)

CERTIFICATE OF RENEWAL OF LICENCE TO OPERATE A BLOOD BANK FOR PROCESSING OF WHOLE HUMAN BLOOD AND/OR* FOR PREPARATION FOR SALE OR DISTRIBUTION OF ITS COMPONENTS

  1. Certified that licence number ________________ granted on ____________ to M/s ________________________________ for the operation of a Blood Bank for processing of whole human and/or for preparation of its components at he premises situated at ____________________________________________ is hereby renewed with effect from ___________ to ____________.

 

   2.  Name(s) of items:

1.

2.

3.

   3. Name(s) of component Technical Staff:

       1.

       2.

       3.

       4.

       5.

       6.

       Dated _______________                      Signature _________________________________

                                                              Name and Designation _______________________

                                                              Licensing Authority

                                                               _______________________________________

                                                              Central Licence Approving Authority

 

* delete whichever is not applicable.";

 

(b)

 after Form 26-H, Form 26-I shall be inserted, namely:-

Form 26-I

(See rule 122-I)

CERTIFICATE OF RENEWAL OF LICENCE FOR 

MANUFACTURE OF BLOOD PRODUCTS

 

Certified that licence number _______________________ granted on ______________ to M/s __________________________ for manufacture of blood products at the premises situated at ___________ is hereby renewed with effect from _______________ to ____________ .

  1. Name(s) of items:

    1.

    2.

    3.

  2. Names of competent Technical Staff

(a) responsible for manufacturing                   (b) responsible for testing

              1.                                                          1.

              2.                                                           2.

              3.                                                           3.

              4.                                                           4.

                                                                      Signature ____________________

                                                                      Name and Designation ___________________

                                                                       Licensing Authority

                                                                       _________________________________

                                                                       Central Licence Approving Authority

 

(c)

 for Form 27-C, the following form shall be substituted, namely:-

Form 27-C

(See rule 122-F)

APPLICATION FOR GRANT/RENEWAL* OF LICENCE FOR THE OPERATION OF A BLOOD BANK FOR

PROCESSING OF WHOLE BLOOD AND/OR* PREPARATION OF BLOOD COMPONENTS

  1. I/We _______________________________________ of M/s _________________________ hereby apply for the grant of licence number _____________________ dated __________________ to operate Blood Bank, for processing of whole blood and/or for preparation of its components on the premises situated at _______________________  .
  2. Name(s) of items:

    1.

    2.

    3.

  3. The name(s), qualification and experience of competent Technical Staff are as under:

        (a) Name(s) of Medical Officer.

        (b) Name(s) of Technical Supervisor

        (c) Name(s) of Registered Nurse.

        (d) Name(s) of Blood Bank Technician.

4.     The premises and plant are ready for inspection/will be ready for inspection on __________.

5.    A licence fee of rupees ____________________________________ and an inspection fee of

       Rupees __________________________________ has been credited to the Government  

       under the Head Account ___________________________ (receipt enclosed).

 

 

                                                                            Signature ________________________

 

      Dated ___________________                               Name and Designation ______________

      

      *delete whichever is not possible.

    

Note 1. The application shall be accompanied by a plan of the premises, list of machinery and equipment for collection, processing, storage and testing of whole blood and its components, memorandum of association/constitution of the firm, copies of certificate relating to educational qualifications and experience of the competent technical staff and documents relating to ownership or tenancy of premises.

 

Note 2. A copy of the application together with the relevant enclosures shall also be sent to the Central Licence Approving Authority and to the concerned Zonal/Sub-Zonal Officers of the Central Drugs Standard Control Organisation.

(d)

 after Form 27-D, the following Form shall be inserted, namely:-

Form 27-E

(See rule 122-F)

 

APPLICATION FOR GRANT/RENEWAL* OF LICENCE TO MANUFACTURE 

BLOOD PRODUCTS FOR SALE OR DISTRIBUTION

  1. I/We _______________________________________ of M/s _________________________ hereby apply for the grant of licence number _____________________ dated __________________ to operate Blood Bank, for processing of whole blood and/or for preparation of its components on the premises situated at _______________________  .
  1. Name(s) of item(s):

    1.

    2.

    3.

    4.

  2. The name(s), qualification and experience of competent Technical Staff are as under:

(a) responsible for manufacturing                   (b) responsible for testing

              1.                                                          1.

              2.                                                          2.

              3.                                                          3.

   4.     The premises and plant are ready for inspection /  will be ready for inspection on _________

   5.     A licence fee of rupees ____________________________________ and an inspection fee of

       Rupees __________________________________ has been credited to the Government  

       under the Head Account ___________________________ (receipt enclosed).

 

                                                                                                                                 

Signature ________________________

      Dated ___________________                               Name and Designation ______________

      

      *delete whichever is not possible.

    

     Note 1. The application shall be accompanied by a plan of the premises, list of machinery and equipment for collection, processing, storage and testing of whole blood and its components, memorandum of association/constitution of the firm, copies of certificate relating to educational qualifications and experience of the competent technical staff and documents relating to ownership or tenancy of premises.

 

     Note 2. A copy of the application together with the relevant enclosures shall also be sent to the Central Licence Approving Authority and to the concerned Zonal/Sub-Zonal Officers of the Central Drugs Standard Control Organisation.

(e)

 for Form 28-C, the following Form shall be substituted, namely:-

Form 28-C

(See rule 122-G)

 

LICENCE TO OPERATE A BLOOD BANK FOR COLLECTION, STORAGE AND PROCESSING OF WHOLE HUMAN BLOOD AND/OR* ITS COMPONENTS FOR SALE OR DISTRIBUTION

  1. Number of licence ________________________ date of issue __________________ at the premises situated at _____________________________________________
  2. M/s ________________________________________________ is hereby licensed to collect, store, process and distribute whole blood and/or its components. 
  3. Name(s) of item(s):

    1.

    2.

    3.

    4.   Name(s) of component Technical Staff:       

    (a) responsible for manufacturing                   (b) responsible for testing

                  1.                                                           1.

                  2.                                                           2.

                  3.                                                           3.

                  4.                                                          4.

    5.    The licence authorises licensee to collect, store, distribute, and processing of whole blood and/or blood components subject to the conditions applicable to this licence.

    6.   The licence shall be in force from ___________________ to __________________

    7.   The licence shall be subject to the conditions stated below and to such other conditions as may be specified from time to time in the Rules made under the Drugs and Cosmetics Act, 1940.

    Dated __________________                                          Signature ____________________

                   Name and Designation ___________________

        Name and Designation ___________________

                                                                              Licensing Authority

                                                                             ____________________________________

                                                                            Central Licence Approving Authority

    * delete whichever is not applicable

CONDITIONS OF LICENCE

1.

 The licensee shall neither collect blood from any professional donor or paid donor nor shall he prepare blood components from the blood collected from such a donor.

2.

 The licence and any certificate of renewal in force shall be displayed on the approved premises and the original shall be produced at the request of an inspector appointed under the Drugs and Cosmetics Act, 1940.

3.

 Any change in the technical staff shall be forthwith reported to the Licensing Authority and/or Central Licence Approving Authority.

4.

 The licensee shall inform the Licensing Authority and/or Central Licence Approving Authority in writing in the event of any change in the constitution of the firm operating under the licence.  Where any change in the constitution of the firm takes place, the current licence shall be deemed to be valid for maximum period of three months from the date on which the change has taken place unless, in the meantime, a fresh licence has been taken from the Licensing Authority and/or Central Licence Approving Authority in the name of the firm with the changed constitution.

(f)

 after Form 28-D, the following form shall be inserted, namely:-

Form 28-E

(See rule 122-G)

 

OF LICENCE TO MANUFACTURE BLOOD PRODUCTS 

FOR SALE OR DISTRIBUTION

  1. Number of licence ________________________ date of issue __________________ at the premises situated at _____________________________________________
  2. M/s ________________________________________________ is hereby licensed to collect, store, sell or distribute the following blood products:- 
  3. Name(s) of item(s):

    1.

    2.

    3.

    4.   Name(s) of component Technical Staff:

          

    (a) responsible for manufacturing                   (b) responsible for testing

                  1.                                                           1.

                  2.                                                           2.

                  3.                                                           3.

    5.    The licence authorises licensee to collect, store, distribute, and processing of whole blood and/or blood components subject to the conditions applicable to this licence.

    6.   The licence shall be in force from ___________________ to __________________

    7.   The licence shall be subject to the conditions stated below and to such other conditions as may be specified from time to time in the Rules made under the Drugs and Cosmetics Act, 1940.

    Dated __________________                                         Signature ____________________

                   Name and Designation ___________________

        Name and Designation ___________________

                                                                             Licensing Authority

                                                                              ____________________________________

                                                                             Central Licence Approving Authority

    * delete whichever is not applicable

 

CONDITIONS OF LICENCE

1.

 The licensee shall not manufacture blood products from the blood drawn from any professional donor or paid donor.

2.

 This licence and any certificate of renewal in force shall be displayed on the approved premises and shall be produced at the request of an Inspector appointed under the Drugs and Cosmetics Act, 1940.

3.

 Any change in the technical staff shall be forthwith reported to the Licensing Authority and/or Central Licence Approving Authority.

4.

 The licensee shall inform the Licensing Authority and/or Central Licence Approving Authority in writing any changes in the constitution of the firm operating under the licence.  In the event of any change in the constitution of hte firm, the licence shall be deemed to be valid for a period of three months from the date on which the change takes place, unless, a fresh licence has been taken form the Licensing Authority and/or Central Licence Approving Authority in the name of the firm with changed constitution.

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