Lok Sabha Question No. 3432 (UNSTARRED), answered on 2016-08-05
Subject: Transfusion Transmitted Infection
Ministry: HEALTH AND FAMILY WELFARE
Asked by: HARISH DWIVEDI, M. CHANDRAKASI

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED  QUESTION NO. 3432 TO BE ANSWERED ON 5 TH AUGUST, 2016

## TRANSFUSION TRANSMIT TED INFECTION

## 3432. SHRI HARISH CHANDRA ALIAS HARISH DWIVEDI: SHRI M. CHANDRAKASI:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

(a) whether the Government has formulated any norms/ guidelines to set up blood banks across the country and if so, the details thereof;

(b) whether the existing blood banks re working in compliance to the above norms and if so, the details thereof and if not, the reasons therefor;

(c) whether Government is aware of rise on Transfusion Transmitted Infection (TTI) cases across the country;

(d) if so, the details thereof and the number of such cases reported during the last three years, State/UT - wise; and

(e) whether the Government has ascertained that the cause of TTI is attributed to blood donated by replacement donors and if so, the details the reof along with the steps taken to curb TTI?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SMT. ANUPRIYA PATEL )

(a): Norms for set up of Blood Banks as approved by Governing Body of National Blood Transfusion Council are as follows: -

Every  district  should  have  at  least  one  blood  bank,  but  clustering  of  blood  ba urban/semi - urban  areas  should  be  avoided.  New  blood banks  need  to  be  set  up  based  on geographic location and population demand only. Reference is at Annexure.

Essential  requirements  for  the  functioning  and  operation  of  a  blood  bank  and/  o preparation of blood components are regulated under the Drugs & Cosmetics Act 1940 & Rules 1945.

(b): Yes.

(c) &(d): Government is monitoring the positivity of TTI in collected blood units ac licensed blood banks of the country and there has been no rising trend in the last thr Cases of TTI are howev er not reported to the ministry.

(e) : No, but all Blood Banks have to mandatorily test every unit of blood for HIV, Syph and Hepatitis B & C & Malaria before it is issued for transfusions in accordance to reg norms  under  Drug  &  Cosmetic  Act 1940  &  Rules  1945  thereof.  All  blood  donors  are  also counseled and screened prior to blood donation to reduce the risk of TTI.

## NORMS FOR STATE BLOOD TRANSFUSION COUNCIL AS APPROVED BY GOVERNING BODY OF NATIONAL BLOOD TRANSFUSION COUNCIL

## A. Norms for set up of New Blood Banks

Every district should have at least one blood bank but clustering of blood banks in urban/semiurban areas should be avoided. New Blood Banks need to be set up based on geographic location and population demand only

## B. Norms for grant of no objection certificate (NOC) by SBTC.

## B1- For new blood bank license -

- 1A Registered voluntary or charitable organization, which is registered in the, territory of union of India or union territory, as the case may be under any such law which is at the time of enforcement of this rule in force.
- 2The aforesaid organization must be at least 2 year old and should not be a family society or trust.
- 3The objective mentioned in the memorandum of association must include the activities related to healthcare delivery system or blood transfusion services.
- 4The activity undertaken by the organization must showcase social accountability and be reflected in the annual audited statement of account of the last two year (i.e before the submission of application).
- 5The organization should submit undertaking to ensure annual blood collection- more than 2000 units per year with nearing 100% contribution from voluntary blood donor, preferably collected from outdoor blood donation camps.
- 6The organization should submit undertaking the appoint medical social worker (MSW) and counselor with the blood bank for arranging voluntary blood donation (VBD) camps and pre and post test counseling respectively.
- 7The organization should submit undertaking to establish blood component separation facility of its own or a storage facility within a period of 2 years from receiving license to operate blood bank.
- 8The organization should submit undertaking to abide with the guideline of - SBTC/NBTC issued from time to time, including the guidelines for processing charges for blood and blood components.
- c- The organization should submit undertaking on the latter head expressing willingness to abide with aforesaid conditions.
- d- The SBTC should process the application within 30 days from the date of its receipt in the office; failing which NOC shall be deemed granted to the organization.

## Note-