Central Govt. amended from time to time the existing requirements of Blood Banks in the Drugs & Cosmetics Act, 1940 and Rules thereunder to meet the latest standards. Consequent to a public litigation case recently, Supreme Court of India directed Central Govt. to enact a comprehensive legislation on Blood Banks in collection, storage, testing and distribution of blood and its components. In this context, the office of Drugs Controller General of India made draft rules to further amend the existing law in the Drugs & Cosmetics Act, 1940 and Rules thereunder to meet the direction of Hon’ble Supreme Court in order to improve the blood banking system in the country.

National Blood Policy

Government of India published in the year 2002 the National Blood Policy. The objective of the policy is to provide safe, adequate quantity of blood, blood components and products. The main aim of the policy is to procure non remunerated regular blood donors by the blood banks. The policy also addresses various issues with regard to technical personnel, research , development and to eliminate profiteering by the blood banks by selling blood. The policy also envisages that fresh licenses to stand alone blood banks in private sector shall not be granted and renewal of such blood banks shall be subjected to thorough scrutiny.

SCENARIO OF LEGAL FRAMEWORK

Human blood is covered under the definition of ‘Drug’ under Sec. 3(b) of Drugs & Cosmetics Act. Hence, it is imperative that Blood Banks need to be regulated under the Drugs & Cosmetics Act and rules thereunder.

In the year 1967, Central Govt. (Ministry of Health) enacted a separate provision in Schedule F Part XII B of Drugs & Cosmetics Rules. Various requirements such as Accommodation, Technical staff, equipments etc. for operation of blood bank were included in this Part. State Drugs Controllers were authorized to issue the licenses for blood banks. The standards for ‘Whole Human Blood’ was prescribed in Indian Pharmacopoeia.

Due to prevalence of AIDS virus, the Ministry of Health & Family Welfare (Govt. of India) issued a notification in the year 1989 under the Drugs and Cosmetics Rules and made the test HIV 1&2 antibodies of Whole Human Blood as mandatory requirement before transfusion. It is imperative that each unit of blood and blood products were regulated in the year 1990 and 3 laboratories viz. NICD Delhi, NIV Pune and CMC, Vellore were notified to function as laboratory under 3A of Drugs and Cosmetics Rules to test HIV antibodies in respect of human blood and human blood products.

As trained technicians were not available in the Blood Banks to carry out the test for HIV 1&2 antibodies, the Ministry of Health & Family Welfare notified 112 Surveillance Centres to act as a testing lab for the blood banks for carrying out the above test (ZBTC). The list of 112 Surveillance Centres is annexed.

Following M/s. Ferguson’s Report (which brought out various deficiencies with regard to quality control of blood and blood products etc. in the year 1990 and based on concern expressed in different fora and in Parliament, the D&C Rules were again amended (Rules 68A, Part XB and Part XIIB of Schedule F) in the year 1992-93 and Drugs Controller General (India) was vested with the power of Central license Approving Authority (CLAA) to approve the license of notified drugs viz. Blood and Blood Products, I.V. Fluids and Vaccines and Sera.

The requirement of a blood bank is inserted in Part X-B of the Drugs and Cosmetics Rules, 1945. The Rules from 122F to 122P explain the various procedure of making applications by a blood bank, fees to be paid for grant/renewal of license by the applicant and conditions of license to be followed by the applicant after grant/renewal and conditions of license to be followed by the applicant after grant/renewal of licnece.

In accordance with the Supreme Court order, blood bank legislation has been extensively revised on 5.4.1999 to include Good Manufacturing Practices, Standard Operating Procedure and validation of equipments etc. The brief requirements for grant/renewal of blood bank licenses are as follows:

PART X-B

REQUIREMENTS FOR THE COLLECTION, STORAGE, PROCESSING AND DISTRIBUTION OF WHOLE HUMAN BLOOD, HUMAN BLOOD COMPONENTS BY BLOOD BANKS AND MANUFACTURE OF BLOOD PRODUCTS

122-EA. Definitions.-
(1) In this Part and in the Forms contained in Schedule A and in Part XII B and Part XIIC of schedule F, unless there is anything repugnant in the subject or context,- (a) ‘apheresis’ means for the process by which blood drawn from a donor, after separating plasma or platelets or leucocytes, is retransfused – simultaneously into the said donor;(b) ‘autologous blood’ means the blood drawn from the patient for re-transfusion unto himself later on;(c) ‘blood’ means and includes whole human blood, drawn from a donor and mixed with an anti-coagulant;(d) ‘blood bank’ means a place or organization or unit or institution or other arrangements made by such organization, unit or institution for carrying out all or any of the operations for collection, apheresis, storage, processing and distribution of blood drawn from donors and/or for preparation, storage and distribution of blood components;(e) ‘blood component’ means a drug prepared, obtained, derived or separated from a unit of blood drawn from a donor;(f) ‘blood product’ means a drug manufactured or obtained from pooled plasma or blood by fractionation, drawn from donors;(g) ‘donor’ means a person who voluntarily donates blood after he has been declared fit after a medical examination, for donating blood, on fulfilling the criteria given hereinafter, without accepting in return any consideration in cash or kind from any source, but does not include a professional or a paid donor.

EXPLANATION
For the purposes of this clause, benefits or incentives like pins, plaques, badges, medals, commendation certificates, time-off from work, membership of blood assurance programme, gifts or little or intrinsic monetary value shall not be construed as consideration;

(h) ‘leucapheresis’ means the process by which the blood drawn from a donor, after leucocyte concentrates have been separated, is re-transfused simultaneously into the said donor;(i) ‘plasmapheresis’ means the process by which the blood drawn from a donor, after plasma has been separated, is re-transfused during the same sitting into the said donor;(j) ‘plateletpheresis’ means the process by which the blood drawn from a donor, after platelet concentrates have been separated, is re-transfused simultaneously into the said donor.(k) ‘professional donor’ means a person who donates blood for a valuable consideration, in cash or kind, from any source, on behalf of the recipient – patient and includes a paid donor or a commercial donor;(l) ‘replacement donor’ means a donor who is a family friend or a relative of the patient –recipient.

122-F. Form of application for license for operation of Blood Bank/processing of whole human blood for components/manufacture or Blood Products for sale or distribution-
(1) Application for the grant and/or renewal of license for the operation of Blood Bank/processing of Human Blood for components/manufacture of Blood Products shall be made to the Licensing Authority appointed under Part VII in Form 27-C or Form 27-E as the case may be and shall be accompanied by license fees of rupees six thousand and an inspection fees of rupees one thousand and five hundred for every inspection thereof or for the purpose of renewal of license.

Provided that if the applicant applies for renewal of license after the expiry but within six months of such expiry the fee payable for the renewal of the licnece shall be rupees six thousand and inspection fees of rupees one thousand and five hundred plus an additional fees at the rate of rupees one thousand per month or a part thereof in additional to the inspection fee.

Provided further that a licensee holding a license in Form 28-C or Form 28-E as the case may be for operation of blood bank/processing of whole human blood for components/manufacture of blood products shall apply for grant of license under sub-rule (1) before the expiry of the said licnece on Form 27-C or Form 27-E as the case may be and he shall continue to operate the same till the orders on his application are communicated to him.

EXPLANATION
For the purpose of this rule, ‘Blood Bank’ means a place or organizational unit or an institution, or other arrangement made by such organizational unit or institution for carrying out all or any of the operations of manufacture of human blood components or blood products or whole human blood for its collection, storage, processing, distribution from selected human donors.}2. A fee of rupees one thousand shall be paid for a duplicate copy of license issued under this rule, if the original is defaced, damaged or lost.3. Application by licensee to manufacture additional drugs listed in the application shall be accompanied by a fee of rupees three hundred for each drug listed in the application.4. On receipt of the application for the grant or renewal of such license, the Licensing Authority shall, -

(i) verify the statements made in the application form.(ii) Cause the manufacturing and testing establishment to be inspected in accordance with the provisions of rules 122-I; and(iii) In case the application is for renewal of license, call for information of past performance of the licensee.

5. If the Licensing Authority is satisfied that the applicant is in position to fulfill the requirements laid down in the rules, he shall prepare a report to that effect and forward it along with the application and the license (in triplicate) to be granted or renewed, duly completed to the Central license Approving Authority:

Provided that if the Licensing Authority is of the opinion that the applicant is not in a position to fulfill the requirements laid down in these rules, he may, by order, for reason to be recorded in writing, refuse to grant or renew the license, as the case may be.

6. If, on receipt of application and the report of the Licensing Authority referred to in Sub-rule 5 and after taking such measures including inspection of the premises, by the inspector, appointed by the Central Govt. under Section 21 of the Act, and/or along with expert in the field concerned if deemed necessary, the Central license Approving Authority, is satisfied that the applicant is in a position to fulfill the requirement laid down in this rule. He may grant or renew the licnece, as the case may be:

Provided that if the Central license Approving Authority is of the opinion that the applicant is not in a position to fulfill the requirements laid down in these rules he may, notwithstanding the report of the Licensing Authority, by order, for reason to be recorded in the writing, reject the application for grant or renewal of license as the case may be and shall supply the applicant with a copy of the inspection report.

122-G. Form of license for the operation of a Blood Bank/Processing of Whole Human Blood for components and manufacture of Blood products and the conditions for the grant or renewal of such license.
processing whole Human Blood for components and manufacture of blood products shall be issued in Form 28-C or Form-28-E or Form 26-G or Form 26-I as the case may be. Before a license in Form 28-C or Form-28-E or Form 26-G or Form 26-I, as the case may be, is granted or renewed the following conditions shall be complied with by the applicant.-

(i) The operation of the Blood Bank and/or processing of whole human blood for components/manufacture of blood product shall be carried out under the active direction and personal supervision of component technical staff consisting of at least one person who is whole time employee and who is a Medical Officer, and possessing-

a) Post Graduate degree in Medicine-M.D. (Pathology/Transfusion Medicines); orb) Degree in Medicine (M.B.B.S.) with Diploma in Pathology or Transfusion Medicines having adequate knowledge in blood group serology, blood group methodology and medical principles involved in the procurement of blood and/or preparation of its components; orc) Degree in Medicine (M.B.B.S.) having experience in Blood Bank for one year during regular service and also has adequate knowledge and experience in blood group serology, blood group methodology and medical principles involved in the procurement of blood and/or preparation of its components, the degree or diploma being from a university recognized by the Central Government.

EXPLANATION
For the purposes of this condition, the experience in Blood Bank for one year shall not apply in the case of persons who are approved by the Licensing Authority and/or Central license Approving Authority prior to the commencement of the Drugs & Cosmetics (Second Amendment) Rules,1999.

(ii) The applicant shall provide adequate space, plant and equipment for any or all the operations of blood collection or blood processing. The space, plant and equipment required for various operations is given in Schedule ‘F’, Part XII-B and / or XII-C.(iii) The applicant shall provide and maintain adequate technical staff as specified in Schedule ‘F’, Part XII-B and/or XII-C.(iv) The applicant shall provide adequate arrangements for storage of Whole Human Blood, Human Blood Components and blood products.(v) The applicant shall furnish to the Licensing Authority, if required to do so, data on the stability of Whole Human Blood, its components or blood products which are likely to deteriorate, for fixing the date of expiry which shall be printed on the labels of such products on the basis of the data so furnished.

122-H. Duration of license.- An original license in Form 28-C or Form 28 –E or a renewed license in Form 26-G or Form 26-I unless sooner suspended or cancelled shall valid for a period of five years and from the date on which the year in which it is granted or renewed.

122-I. Inspection before grant or renewal of license for operation of Blood Bank, processing of Whole Human Blood for Components and Manufacture of Blood Products.- license in Form 28-C or Form 28 –E is granted or a renewal of license in Form 26-G or Form 26-I is made ,as the case may be, the Licensing Authority or Central license Approving Authority, as the case may be , shall cause the establishment in which Blood Bank is proposed to be operated/ whole human blood for component is processed[/] blood products are manufactured to be inspected by one or more inspectors, appointed under the Act and / or along with the Expert in the field concerned. The Inspector or Inspectors shall examine all portions of the premises and appliances/ equipments and inspect the process of manufacture intended to be employed or being employed along with the means to be employed or being employed for operation of blood bank/processing of whole human blood for components/ manufacture of blood products together with their [testing] facilities and also enquire into the professional qualification of the expert staff and other technical staff to be employed.

122-J. Report by Inspector.- The Inspector or Inspectors shall forward a detailed descriptive report giving his finding on each aspect of inspection along with his recommendation in accordance with the provisions of Rule 122-I to the Licensing Authority or to the Central license Approving Authority.

122-K. Further application after rejection.- If within a period of six months from the rejection of application for a license the applicant informs the licensing Authority that the conditions laid down have been satisfied and deposits an inspection fee of rupees two hundred and fifty the Licensing Authority, if after causing further inspection to be made is satisfied that the conditions for the grant of a license have been complied with, shall grant or renew a license in Form 28-C or Form 28 –E;

Provided that in case of drug notified by the Central Government under rule 68-A, the application , together with the inspection report and the Form of license (in triplicate to be granted or renewed), duly completed shall be sent, to the Central license Approving Authority, who may approve the same and return it to the licensing Authority for issue of the license.

122-L. Delegation of powers by the Central Licensing Approving Authority.- The Central Licensing Approving Authority may, with the approval of the Central Government, by notification delegate his power of signing licenses and any other power under rules to persons under his control having same qualifications as prescribed for Controlling Authority under Rule 50-A, for such areas and for such periods as may be specified.

122-M. Provision for appeal to the State Government by a Party whose license has not been granted or renewed.- Any person who is aggrieved by the order passed by the Licensing Authority or Central license Approving Authority, as the case may be, may within thirty days from the date of receipt of such order, appeal to the State Government or Central Government, as the case may be, after such enquiry, into the matter as it considers necessary and after giving the said person an opportunity for representing his view in the matter may pass such order in relation thereto as it thinks fit.

122-N. additional information to be furnished by an [applicant] for license or by a licensee to the Licensing Authority.- The applicant for the grant of license or any person granted a license under the part shall, on demand furnish to the Licensing Authority, before the grant of the license or during the period the license is in force as, as the case may be, documentary evidence in respect of the ownership or occupation, rental or other basis of the premises, specified in the application for license or in the license granted, constitution of the firm or any other relevant matter, which may be required for the purpose of verifying the correctness of the statement made by the applicant or the licensee, while applying for or after obtaining the license, as the case may be.

122-O.Cancellation and suspension of licenses.-
(1) The Licensing Authority or Central license Approving Authority may for such licenses granted or renewed by him after giving the licensee an opportunity to show cause by such an order should not be passed by an order in writing stating the reason thereof, cancel a license issued under this part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates, [or direct the licensee to stop collection, storage, processing, manufacture and distribution of the said substances and [thereupon order the destruction of substances and] stocks thereof in the presence of an Inspector] if in his opinion, the licensee has failed to comply with any of the conditions of the license or with any provision of the Act or Rules thereunder.(2) A licensee whose license has been suspended or cancelled, within three months of the date of the order under sub-rule (1) prefer an appeal against that order to the State Government or Central Government, which shall decide the same.

122-P. Conditions of license- A license in Form 28-C, Form 28-E, Form 26-G or Form 26-I shall be subject to the special conditions set out in Schedule F, Part XII-B and Part XII-C, as the case may be, which relate to the substance in respect of which the license is granted or renewed and to the following general conditions, namely:-

(i) (a) The licensee shall provide and maintain adequate staff, plant and premises for the proper operation of a Blood Bank for processing whole human blood, its components and/or manufacture of blood products.(b) The licensee shall maintain staff, premises and equipments as specified in Rule 122-G. The licensee shall maintain necessary records and registers as specified in Schedule F, Parts XII-B and XII-C.(c) The licensee shall test in his own laboratory whole human blood, its components and blood products and [maintain records and] registers in respect of such tests as specified in Schedule F, Part XII-B and Part XII-C. The records and registers shall be maintained for a period of five years from the date of manufacture.(d) The licensee shall maintain/preserve reference [sample and] supply to the Inspector the reference sample of the whole human blood collected by him in adequate quantity to conduct all the prescribed tests. The licensee shall supply to the Inspector the reference sample for the purpose of testing.

(ii) The licensee shall allow an inspector appointed under the Act to enter, with or [without] prior notice, any premises where the activities of the Blood Bank are being carried out, for the processing of Whole Human Blood and/or Blood Products, to inspect the premises and plant and the process of manufacture and the means employed for standardizing and testing the substance.(iii) The licensee shall allow an Inspector appointed under the Act to inspect all registers and records maintained under these rules and to take samples of the manufactured product and shall supply to Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and Rules thereunder have been observed.(iv) The licensee shall from time to time report to the Licensing Authority any changes in the expert staff responsible for the operation of a Blood Bank/processing of whole human blood for components and/or manufacture of blood products and any material alterations in the premises or plant used for that purpose which have been made since the date of last inspection made on behalf of the Licensing Authority before the grant of the license.(v) The licensee shall on request furnish to the Licensing Authority, or Central license Approving Authority or to such Authority as the Licensing Authority, or the Central license Approving Authority may direct, from any batch unit of drugs as the Licensing Authority or the Central license Approving may from time to time specify, sample of such quantity as may be considered adequate by such Authority for any examination and, if so required, also furnish full protocols of the test which have been applied.(vi) If the Licensing Authority or the Central license Approving Authority so directs, the licensee shall not sell or offer for sale any batch/unit in respect of which a sample is, or protocols are furnished under the last preceding sub-paragraph until a certificate authorizing the sales of batch/unit has been issued to him by or on behalf of the Licensing Authority or the Central license Approving Authority.(vii) The licensee shall on being informed by the Licensing Authority or the Controlling Authority that any part of any batch/unit of the substance has been found by the Licensing Authority or the Central license Approving Authority not to conform with the standards of strength, quality or purity specified in these Rules and on being directed so to do so, withdraw, from sales and so far as may in the particular circumstances of the case be practicable recall all issues already made from that batch/unit.(viii) No drug manufactured under the license shall be sold unless the precautions necessary for preserving its properties have been observed throughout the period after manufacture. Further no batch/unit manufactured under this license shall be supplied/distributed to any person without prescription of Registered Medical Practitioner.(ix) The licensee shall comply with the provisions of the Act and of these Rules and with such further requirements, if any, as may be specified in any Rules subsequently made under Chapter IV of the Act, provided that where such further requirements are specified in the Rules, these would come in force four months after publication in the Official Gazette.(x) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and defects noticed.(xi) The licensee shall destroy the stocks of batch/unit which does not comply with standard tests in such a way that it would not spread any disease/infection by way of proper disinfection method.(xii) All bio-medical waste shall be treated, disposed off or destroyed as per the provisions of The Bio-Medical Wastes (Management and Handling) Rules 1996.(xiii) The licensee shall neither collect blood from any professional donor or paid donor nor shall he prepare blood components and/or manufacture blood products from the blood drawn from such a donor.

'Form 26-G(See Rule 122-F)

CERTIFICATE OF RENEWAL OF license TO OPERATE A BLOOD BANK FOR PROCESSING OFWHOLE HUMAN BLOOD AND/OR* FOR PREPARATION FOR SALE OR DISTRIBUTION OF ITS COMPONENTS
1. Certified that license number ________________________granted on ________ to M/s ___________________________________ for the operation of a Blood Bank for processing of whole blood and / or for preparation of its components at the premises situated at _______________________ is hereby renewed with effect from ________________ to ___________________.

2. Name (s) of Items :
1.2.3.

3. Name(s) of competent Technical Staff :
> 1.2.3.4.5.6.

(b) after Form 26-H, the following Form shall be inserted, namely :-

“Form 27-C(See rule 122-F)

APPLICATION FOR GRANT / RENEWAL * OF license FOR THE OPERATION OF ABLOOD BANK FOR PROCESSING OF WHOLE BLOOD AND/OR* PREPARATION OF BLOOD COMPONENTS
1. I/We ___________________of M/s_______________________________hereby apply for the grant of license / renewal of license number ______________dated _______________________ to operate a Blood Bank, for processing of whole blood and/or* for preparation of its components on the premises situated at ______________________________________________________.

2. Name(s) of the item(s):
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 license fee of rupees ___________________________________ and an inspection fee of rupees ________________________________ has been credited to the Government under the Head of Account _______________________ (receipt enclosed).

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 the premises.2. A copy of the application together with the relevant enclosures shall also be sent to the Central license Approving Authority and to the concerned Zonal/Sub- Zonal Officers of the Central Drugs Standard Control Organization.”;

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

“Form 27-C(See rule 122-F)APPLICATION FOR GRANT / RENEWAL * OF license FOR THE OPERATIONOF 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 license / renewal of license number ______________dated _______________________ to operate a Blood Bank, for processing of whole blood and/or* for preparation of its components on the premises situated at ______________________________________________________.

2. Name(s) of the item(s):
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 license fee of rupees ___________________________________ and an inspection fee of rupees ________________________________ has been credited to the Government under the Head of Account _______________________ (receipt enclosed).

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 the premises.2. A copy of the application together with the relevant enclosures shall also be sent to the Central license Approving Authority and to the concerned Zonal/Sub- Zonal Officers of the Central Drugs Standard Control Organization.”;

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

“Form 27-E(See rule 122-F)APPLICATION FOR GRANT/RENEWAL*OF licenseTO MANUFACTURE BLOOD PRODUCTS FOR SALE OR DISTRIBUTION
1. I/We ____________________of M/s___________________________hereby apply for the grant of license/renewal of license number _____________________ dated _____________________ to manufacture blood products on the premises situated at ______________________

2. Name(s) of item(s) :
1.2.3.4.

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

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

5. A license fee of rupees ______________and an inspection fee of rupees ___________________________ has been credited to the Government under the Head of Account _________________ (receipt enclosed),

NOTE:1. The application shall be accompanied by a plan of the premises, list of machinery and equipment for manufacture of blood products, 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 the said premises.2. A copy of the application together with the relevant enclosures shall also be sent to the Central license 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)license TO OPERATE A BLOOD BANK FOR COLLECTION, STORAGEAND PROCESSING OF WHOLE HUMAN BLOOD AND/OR* ITS COMPONENTS FOR SALE OR DISTRIBUTION
1. Number of license _____________________ 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 the item(s):
1.2.3.

4. Name(s) of competent Technical Staff :
1.2.3.4.5.6.

5. The license authorizes licensee to manufacture, store, sell or distribute the blood products, subject to the conditions applicable to this license.

6. The license shall be in force from ____________ to _____________

7. The license 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.

Conditions of license

1. The licensee shall neither collect blood from any professional donor nor paid donor nor shall he prepare blood components from the blood collected from such a donor.2. The license 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 license Approving Authority.4. The licensee shall inform the Licensing Authority and/or Central license Approving Authority in writing in the event of any change in the constitution of the firm operating under the license. Where any change in the constitution of the firm takes place, the current license 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 license has been taken from the Licensing Authority and/or Central license Approving Authority in the name of the firm with the changed constitution.”;

PART XII BREQUIREMENTS FOR THE FUNCTIONING AND OPERATION OFA BLOOD BANK AND / OR FOR PREPARATION OF BLOOD COMPONENTS.

I. BLOOD BANKS / BLOOD COMPONENTS

A. GENERAL:
1. Location and Surroundings:
The blood bank shall be located at a place which shall be away from open sewage, drain, public lavatory or similar unhygienic surroundings.

2. Building:
The building (s), used for operation of a blood bank and/or preparation of blood components shall be constructed in such a manner so as to permit the operation of the blood bank and preparation of blood components under hygienic conditions and shall avoid the entry of insects, rodents and flies. It shall be well lighted, ventilated and screened (mesh), wherever necessary. The walls and floors of the rooms, where collection of blood or preparation of blood components or blood products is carried out shall be smooth, washable and capable of being kept clean. Drains shall be of adequate size and where connected directly to a sewer, shall be equipped with traps to prevent back siphonage.

3. Health, clothing and sanitation of staff :
The employees shall be free from contagious or infectious diseases. They shall be provided with clean overalls, head-gears, foot-wears and gloves, wherever required. There shall be adequate, clean and convenient hand washing and toilet facilities.

B. ACCOMODATION FOR A BLOOD BANK:
A blood bank shall have an area of 100 square meters for its operations and an additional area of 50 square meters for preparation of blood components. It shall be consisting of a room each for:-

(1) Registration and medical examination with adequate furniture and facilities for registration and selection of donors;(2) blood collection (air-conditioned);(3) blood component preparation. (This shall be air-conditioned to maintain temperature between 20 degree centigrade to 25 degree centigrade);(4) laboratory for blood group serology. (air-conditioned(5) laboratory for blood transmissible diseases like Hepatitis, Syphilis, Malaria, HIV-antibodies (air-conditioned);(6) sterilization-cum-washing;(7) refreshment-cum-rest room (air-conditioned);(8) store-cum-records.

NOTES:
(1) The above requirements as to accommodation and area may be relaxed, In respect of testing laboratories and sterilization-cum-washing room, for reasons to be recorded in writing by the Licensing Authority and / or the Central license Approving Authority, in respect of blood banks operating in Hospitals, provided the hospital concerned has a pathological laboratory and a sterilization-cum-washing room common with other departments in the said hospital.(2) Refreshments to the donor after phlebotomy shall be served so that he is kept under observation in the Blood Bank.

C. PERSONNEL:
Every blood bank shall have following categories of whole time competent technical staff :-

(a) Medical Officer, possessing the qualifications specified in condition of rule 122-G.(b) Blood Bank Technician(s), possessing -

(i) Degree in Medical Laboratory Technology (M.L.T.) with six months' experience in the testing of blood and/or its components; or(ii) Diploma in Medical Laboratory Technology (MLT) with one year's experience in the testing of blood and/or its components, the degree or diploma being from a University/Institution recognised by the Central Government or State Government.

(c) Registered Nurse(s).
(d) Technical Supervisor(where blood components are manufactured), possessing -

(i) Degree in Medical Laboratory Technology (M.L.T.) with six months' experience in the preparation of blood components; or(ii) Diploma in Medical Laboratory Technology (M.L.T) with one year's experience in the preparation of blood components, the degree or diploma being from a University/Institution recognised by the Central Government or State Government.

NOTES:
(1) The requirements of qualification and experience in respect of Technical Supervisor and Blood Bank Technician shall apply in the cases of persons who are approved by the Licensing Authority and/or Central license Approving Authority after the commencement of the Drugs and Cosmetics( Amendment) Rules, 1999.(2) As regards, the number of whole time competent technical personnel, the blood bank shall comply with the requirements laid down in the Directorate General of Health Services Manual.(3) It shall be the responsibility of the licensee to ensure through maintenance of records and other latest techniques used in blood banking system that the personnel involved in blood banking activities for collection, storage, testing and distribution are adequately trained in the current Good Manufacturing Practices/Standard Operating Procedures for the tasks undertaken by each personnel. The personnel shall be made aware of the principles of Good Manufacturing Practices/Standard operating Procedures that affect them and receive initial and continuing training relevant to their needs.

D. MAINTENANCE:
The premises shall be maintained in a clean and proper manner to ensure adequate cleaning and maintenance of proper operations. The facilities shall include:-

(1) Privacy and thorough examination of individuals to determine their suitability as donors.(2) Collection of blood from donors with minimal risk of contamination or exposure to activities and equipment unrelated to blood collection.(3) Storage of blood or blood components pending completion of tests.(4) Provision for quarantine, storage of blood and blood components in a designated location, pending repetition of those tests that initially give questionable serological results.(5) Provision for quarantine, storage, handling and disposal of products and reagents not suitable for use.(6) Storage of finished products prior to distribution or issue.(7) Proper collection, processing, compatibility testing, storage and distribution of blood and blood components to prevent contamination.(8) Adequate and proper performance of all procedures relating to plasmapheresis, plateletpheresis and leucapheresis.(9) Proper conduct of all packaging, labeling and other finishing operations.(10) Provision for safe and sanitary disposal of-

(i) Blood and/or blood components not suitable for use, distribution or sale.(ii) Trash and items used during the collection, processing and compatibility testing of blood and/or blood components.

E. EQUIPMENT:
Equipment used in the collection, processing, testing, storage and sale/distribution of blood and its components shall be maintained in a clean and proper manner and so placed as to facilitate cleaning and maintenance. The equipment shall be observed, standardised and calibrated on a regularly scheduled basis as described in the Standard Operating Procedures Manual and shell operate in the manner for which it was designed so as to ensure compliance with the official requirements (the equipments) as stated below for blood and its components.

Equipment that shall be observed, standardised and calibrated with at least the following frequencies :-