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Year : 2013  |  Volume : 137  |  Issue : 6  |  Page : 1212-1213

WHO Expert Committee on Biological Standardization, 59 th Report

National Institute of Immunology Aruna Asaf Ali Marg J.N.U. Complex New Delhi 110 067, India

Date of Web Publication4-Jul-2013

Correspondence Address:
N K Ganguly
National Institute of Immunology Aruna Asaf Ali Marg J.N.U. Complex New Delhi 110 067
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Source of Support: None, Conflict of Interest: None

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How to cite this article:
Ganguly N K. WHO Expert Committee on Biological Standardization, 59 th Report. Indian J Med Res 2013;137:1212-3

How to cite this URL:
Ganguly N K. WHO Expert Committee on Biological Standardization, 59 th Report. Indian J Med Res [serial online] 2013 [cited 2021 May 6];137:1212-3. Available from:

WHO Expert Committee on Biological Standardization, 59 th Report, Technical Report Series, No. 964 (World Health Organization, Geneva, Switzerland) 2012. 236 pages. Price: US$ 60.00; CHF 50.00
ISBN 978-92-4-120964-9

WHO had prepared a detailed Report on Biological Standardization on the recommendation of the Expert Committee. This technical report covers the various important issues taken up by the committee and also gives the strategic direction in biological standardization as per the committee's recommendation. The Report deals with various aspects of production and control of vaccines and other biologicals along with the establishment of international biological reference materials, and gives special emphasis on the guidelines for production, control and regulation of snake anti-venom immunoglobulins which is of high significance for manufacturers and the national regulatory authorities. In addition, the Report incorporates addendum to the WHO guidelines on yellow fever vaccine. Also included are several other guidelines and recommendations for biological substances used in medicine. The list of guidelines and recommendation also includes the international standards and reference reagents for biological substances.

The Report begins by discussing the observation made by the committee on the progress made in the direction of the biological material standardization under the leadership of WHO. The main focus is to integrate and coordinate information and activities of Drug Regulatory Authorities and regulatory networks as per the International Health Regulation (IHR), 2005 recommendations. It has been recognized that the WHO plays an important role in strengthening the clinical trials and the regulatory infrastructure, particularly in the developing countries. However, due to lack of proper regulatory mechanisms in many countries there are several hindrances in introduction of newer innovative products that are of potential public health benefit. Another important aspect was promotion of continuous interaction in between meetings of expert advisory panel and also improving the networks between various collaborative centers by means of teleconferencing and biennial meetings. The need for continuous monitoring of the pharmaceutical reference preparation, stability monitoring and the harmonization of pharmacopoeial reference materials has been suggested to WHO to act upon by the expert committee. The need for development of WHO guidance and regulatory mechanism for biosimilars, and urgent requirement to revise the standards for yellow fever vaccine, pneumococcal vaccine, cell surface and acellular pertussis vaccine along with documentation relating to lot release of vaccines were brought to focus. The need for strategic direction for standardization of blood products and related in vitro diagnostics, most importantly in the countries of Asia, Africa and in the Eastern Mediterranean countries has been highlighted. Important contributions from the WHO libraries and collaborating centers [NIBSC, England; PEI, Germany; CBER (FDA), USA] have been mentioned along with their upcoming programmes. The Report discusses the important aspects taken up by the expert committee on specification of pharmaceutical preparations, in regard to the international non proprietary names of new pharmaceutical drugs, the transition of the assay systems from biological to chemical, good manufacturing practices of medicines, maintenance of cold chain for distribution of preparations like vaccines which are temperature sensitive with special emphasis on the quality control aspects and the relevance of international standards for quality control for biologicals.

The recommendations, guidelines and matters related to the manufacture and quality control of the biological therapeutic products are included. The committee narrowed the scope of the products to well established and characterized recombinant proteins and keeping out the vaccine and blood products at this stage. Vaccine and blood products have been taken up as a separate entity later in the Report. The committee also proposed to revise the documentation for the licensing processes for biologicals.

The Report also cites the committee's observation on the progress of the poliovirus vaccine programme including the social and political environments especially in the countries like Afghansitan, Nigeria and India. The committee noted that when all the improvements as per the recommendations are in place and after obtaining reports on vaccine programme efficacy, the decision to revise the WHO poliovirus vaccine (oral, attenuated) can be considered. The committee had endorsed high priority for the vaccine development for dengue fever, malaria, HIV and cholera. Other important issues as noted by the committee and mentioned in the Report are revision of recommendations of OPV, IPV and BCG as well as adjuvants, re-evaluation of products after changes in the manufacturer and guidance on clinical assessment, and vaccine nomenclature and good manufacturing practices.

The treatment from venomous snake bites from around the world especially from countries of sub-Saharan Africa, South East Asia and as well as other parts of world need urgent attention. The committee has noted in the Report the need for more effective initiatives to make available specific anti-venom immunoglobulins to treat specific type of envenoming encountered in various parts of the world. The Report cites in full details the WHO guidelines for production, control, regulation of anti-venom immunoglobulin along with the recommendations given by the committee. The Report highlights as to how the WHO and the International Society for Blood Transfusion are collaborating to enhance resource development in the critical area of blood products and their regulation. It contains standards for blood products and related substances such as anti-hepatitis B surface antigen (anti-HBs); blood coagulation factor IX concentrate; Factor VIIa concentrate; Parovirus B19 DNA, plasma human; anti-hepatitis B core antigen (anti-HBc), plasma, human; anti-A and anti-B intravenous immunoglobulin, human; and alpha-1-antitrypsin.

Antibiotic and antigen related international reference materials relating to international standard for antibiotic gramicidin, influenza H5N1 antibody (human), human papillomavirus type 16 DNA and human papillomavirus type 18 DNA for NAT assay, rabies vaccine, acellular pertussis vaccine (standard for potency assay by Modified Kendrick Test), pertussis antiserum (human) have been given, as also the international standards for insulin-like growth factor (IGF-1) and reference panel reports for molecular genetics based diagnostic reagents.

In all, the WHO 59 th Expert Committee Report is informative and comprehensive and a must reference for all stakeholders involved in drugs, diagnostics and vaccines. The book is recommended for both students and scientists of biomedical research.


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