Diseases & National Health Programme
For operating the Blood bank license given by:
|C||State health ministry/ ministry of health|
|D||Drug controller general of INDIA|
a. An adequate legal framework has been provided in Schedule X B of the Drugs and Cosmetics Act/Rules published
b. The Gazette of India: Extraordinary (Part II-Sec.3 (i) which stipulates mandatory testing of blood for Blood transmissible Diseases, including HIV.
c. The rules provide for adequate testing procedures, quality control, standard qualifications and experience for blood bank personnel, maintenance of complete and accurate records, etc.
d. The Drugs Controller General (India) is the Central Licence Approving Authority whereas the regulatory control remains under the dual authority of the State and the Central Government. (option c). The blood banks under the Act require a manufacturing licence.
e. Ensuring the widespread availability of safe and clean blood is a critical component of the National AIDS Prevention and Control Programme. NACO articulates policy, and the operational strategies for a country-wide programme on blood safety, supports strengthening of infrastructure and ensures quality in all aspects of service delivery.
f. A National Blood Policy formulated by NACO, in 2002 and a meticulous Action Plan on Blood Safety formulated in 2003 were adopted by Government. Through this Action Plan on Blood Safety NACO has:
a. l Mandated the revelation of HIV status to the result-seeking donor, not attempted previously in India.This enabled commencement of antiretroviral treatment for people living with HIV/AIDS.
b. l Commenced the process of accreditation of blood banks to ensure uniform implementation of standard operating procedures, not attempted previously in the government sector. Our Quality Management Programme in collaboration with the WHO will enhance standards of blood transfusion services across the country.
c. l Raised the overall collection of blood through voluntary blood donation. We continue to aggressively motivate all segments of our healthy population, particularly the youth, to participate in voluntary blood donation programme. Blood collection from voluntary (non-remunerated) blood donors are definitely on the rise, particularly in states such as Maharashtra and West Bengal. The State AIDS Control Societies has undertaken several activities to promote public awareness of the need for voluntary blood donation and safe blood.
d. l Introduced the installation of blood storage centres at First Referral Units (FRUs), at sub district levels, for wider availability of safe blood, particularly for emergency obstetric care and trauma care services.Developing Infrastructure During 1992-1999, 815 public sector blood banks and those run by charitable organizations were modernized, 40 blood component separation facilities were established and a countrywide network of HIV testing facilities was set up.
e. The National and State Blood Transfusion Councils were registered as societies in 1996, to be supported by the National AIDS Control Organisation (NACO). At state levels, these councils maintain oversight over the voluntary blood donation, the appropriate clinical use of blood, training and manpower development, and supervision of the blood safety programme.
f. NACO supports the modernization of all major blood banks at state and district levels, and repeated refresher training for clinicians on the "Appropriate Clinical Use of Blood.".
g. Ten state-of-the-art model blood banks are being set up in eight under-served states and will be initially managed by NACO prior to being handed over to the respective state governments.