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Asian J Transfus Sci. 2012 Jul-Dec; 6(2): 190–192.
PMCID: PMC3439766
Effective implementation of regulations and facilitation in improving blood transfusion services in Gujarat state
A. Ramkishan, V. K. Gupta, H. G. Koshia, K. K. Goswami, K. K. Shah, and Ripal J. Shah
Central Drugs Standard Control Organisation, Ahmedabad, India
Correspondence to: Dr. A. Ramkishan, Asst. Drugs Controller (I), CDSCO, Air Cargo Complex, Airport, Ahmedabad-380 016, Gujarat, India. E-mail: drramkishan/at/yahoo.com
Sir,
Blood transfusion service (BTS) is the vital part of modern healthcare system without which efficient medical care is impossible. The aim of BTS is to provide safe, quality, effective and efficacious blood and blood components for the benefit of patients. It is a complex organization, requiring careful designing and management.[1] In many countries BTS falls under the control of National Regulatory Authorities concerned with safety and efficacy of blood and blood components.[2] India with a population of about 1.2 billion as well as smaller countries like Bhutan in South-East Asian region were playing significant role in transfusion services as stated by World Health Organization, Geneva.[3] About 10 million blood units are collected in SEARO region and there are more than 2500 blood banks located in India which are licensed by Central License Approving Authority (CLAA-DCG(I)) and State Licensing Authorities (SLA) of respective States of the Country for safe blood supply under the requirements of Schedule F part XII B and C of Drugs and Cosmetics Act 1940 and rules there under.[4,11]
There are few basic parameters about quality standard of BTS in India, one of them is National Blood Policy in which the Regulatory Authorities (FDCA and CDSCO) and other Government agencies like National AIDS Control organization and their State counterparts were functioning in efficient manner for strict enforcement of blood banks to keep good transfusion practices for the collection and use of safe, quality, pure and efficacious whole human blood and blood components in clinical practice.[5] The national blood policy is effective in seven countries of South-East Asian region like India, Bhutan, Maldives, Nepal, Myanmar, Sri Lanka and Thailand.[4] The blood banks in India are enforced by CLAA and SLA along with SBTC/NACO technical expert for the requirements of infrastructure, donor selection, quality parameters, collection, testing, storage, transportation, issue, blood donation camps, cold chain maintenance, stability of blood bags, documentation, records, quality assurance, SOPs, quality manual and other required documents to keep good transfusion practices for safe transfusion in clinical practice.[6]
About 8 million units of whole human blood is collected every year; however, as per norm of 1% blood donation by population, there is a gap of about 4 million units collection in India. It is questionable how this huge gap is apparently not reflecting on routine operation of Indian blood transfusion services. The Indian BTS is highly fragmented and there are approximately 2517 blood banks in the country as per the available records of CDSCO.[6] There are 973 blood banks managed by Central/State Governments, 1544 voluntary blood banks, private standalone and hospital-based blood banks and charitable blood banks.[6] However it is nationally coordinated by National Aids Control Organization (NACO) which is under Government of India, Ministry of Health and Family Welfare, New Delhi. As per the NACO statistics, about 35% blood units are separated into its components and all collected units are tested for 5 transfusion associated infections (HIV, HBsAG, HCV, VDRL and malaria). BTS in India is in fairly advanced stage which is mainly concentrated in urban areas and also regulatory authorities are concentrating in rural area blood banks for collection of voluntary blood units and also awareness on HIV and other diseases for safe transfusion.[7,8]
Testing for infectious markers is the basic necessity to make safe transfusion. As per the country regulation, types of tests and minimum standards are defined in SEARO countries. Thailand is the only country which does NAT testing regularly on majority of blood units collected to reduce the possibility of viral disease transmission. However in the state of Gujarat some of the blood banks started carrying out NAT testing on blood units collected to reduce the TTD transmission. It is a well-known fact that carrying out tests in BTS is not sufficient unless proper QA/QC system is implemented. Another area which needs improvement is hemovigilance. It is nonexistent in this country due to lack of proper coordinating agency at different regional level. We do not know long-term implications of blood transfusions on patients in this part of country.[1,3,7,9]
The national blood policy was established in the year 2003 and also firm regulatory in place since 1993 for safe blood transfusion. If we see the changing mechanisms and effective implementation of regulations and facilitation in improving blood transfusion services in the state of Gujarat is found to be remarkable since July, 2002 to till date in respect of basic quality parameters on BTS.[4]
The Gujarat State Council for Blood Transfusion was established in the year 1997 at Ahmedabad to provide safe, quality blood and blood components. In the year 2002 to 2008 radical changes took place in strict enforcement of Blood Banks by FDCA and CDSCO along with Gujarat State Council to provide safe and quality blood and its components. There were 171 blood banks in the year 2002 and out of which 33 blood banks were recommended to stop the blood tapping activities with immediate effect due to non-compliances of Sch. F and also in respect of QA/QC system and 18 blood banks were recommended for cancellation of license due to serious violations in the year 2002 and as on date there are 153 blood banks in Gujarat. Among these, 68 blood banks are managed by charitable trust, 30 blood banks are managed by Government, 13 blood banks are managed by Indian Red Cross Society and 42 blood banks are managed by private/corporate hospitals, which were approved under CLAA scheme and maintaining all quality parameters for safe transfusion.[8]
In the year 2006-07, out of total collection of 576932 units, voluntary donations were 350118 units (60.7%). At a rate of increase of 10% in total collection and approximate same rise in the voluntary collection, in the year 2011-12 (till October 2011) total donation was 456754 units with 80% through voluntary donations.[8]
There is continual decline in the rate of TTI among the donor populations over last 5 years. For HIV infections, with a steady decline it drops down from 0.27% in the year 2006-07 to 0.17% in the year 2011-12 (till October 2011). There is continuous reduction in other TTIs with 0.23% and 0.99% in the year 2006-07 to 0.13% and 0.67% in the year 2011-12 for Hepatitis B and Hepatitis C respectively [Figure 1].[8]
Figure 1
Figure 1
Component separation in continuously increasing and in the way it passes on the benefits to many patients. It increased from 33.7% in 2006-07 to 50.51% in the year 2011-12 (till October 2011).[8]
This also suggests a trend of improved blood safety with increased voluntary donation, more componentization and reduced TTI without increasing the number of blood banks.[8,10]
Blood transfusion is very important and it is an altruistic model act of ethical responsibility. The FDCA, CDSCO, GSCBT and NACO, New Delhi has excellent coordination for information, education, communication system on voluntary donation, quality standards, quality assurance, SOPs, QC testing of infectious diseases, cold chain maintenance, equipments qualification/validation, approval of blood storage center's, conducting for outdoor blood donation camps, providing training on technical staff, transportation/issue and its administration to ensure that health care professionals provide both donor and recipient all required updated information on BTS at all times for safe transfusion in the state of Gujarat.
The Gujarat state has excellent and effective implementation of regulations and facilitation in improving blood transfusion services for the collection of 100% voluntary blood donation as per National Blood Policy.
An updated legal system will precisely encourage more people to become regular donors. Ministry of Health and Family Welfare, Government of India, New Delhi is in the process of making rules for sampling of blood units and its components in case of unauthorized blood tapping for necessary prosecution in the interest of public as per Drugs and Cosmetics Act 1940 and rules there under 1945.
The Drugs Controller General (I) has delegated the powers of Licensing Authority i.e. CLAA to all Zonal offices of CDSCO for renewal of licenses to operate blood banks across the country. The licensing authority for renewal of blood bank licenses in West Zone (States of Maharashtra, Gujarat, Madhya Pradesh, Chhattisgarh, Goa, Dadra Nagar Haveli (DNH) and Daman/Diu) is Dr. A. Ramkishan for counter signature of licenses in Form 26G on behalf of CLAA. The Ministry of Health and Family Welfare proactively working for blood transfusion services to meet safe transfusion in clinical practice for pending applications to accord on top priority by delegating the powers to all zonal offices of CDSCO.
Acknowledgment
Food and Drugs Control Administration, Gandhinagar; Gujarat State Council for Blood Transfusion, Ahmedabad; Central Drugs Standard Control Organization, West Zone and Zonal office Ahmedabad, Gujarat, India.
1. Govt. of India by DGHS. 2nd ed 2003. Transfusion Medicine, Technical Manual.
2. 2nd ed. London: HMSO; 1993. UKBTS/NIBS Liaison Groups. Guidelines for the blood transfusion services.
3. Simla, HP, India: WHO Project; 2001. Quality Management Training in Blood Transfusion services in India, Report of National Meeting 19-20, July.
4. National Blood Policy India. 2001. May 31st, [Last accessed on 2011 Dec 13]. Available from: http://www.naco.nic.in .
5. Standards for Blood banks and BTS NACO, MOHF&W, Govt. of India, New Delhi. 2007
6. Schedule F part XII B and C of Drugs and Cosmetics Act 1940 and rules there under. [Last accessed on 2011 Dec 13]. Available from: http://www.cdsco.nic.in .
7. Primary Healthcare and Public Private partnership: An Indian Perspective. Ann Trop Med Public Health. 2009;2:46–52.
8. Guidelines of NACO, Gujarat State Council for Blood Transfusion (GSCBT), CDSCO-MOH and FW New Delhi
9. Quality Assurance in Blood Transfusion Services. French J. 2002;60:318–25.
10. Voluntary Blood Donation Program: An operational guidelines prepared by NACO, New Delhi. 2007
11. Blood Safety and Clinical Technology. Available from: http://www.searo.who.int/en/Section10/Section17/Section58/Section219.htm. Quality Assurance in Blood Transfusion Services in SEAR Countries (Report of an Inter-Country Workshop), Bangkok-Thailand from 24-28 August 1998 .
Articles from Asian Journal of Transfusion Science are provided here courtesy of
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