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ICMR to identify and certify Poliovirus Essential Facilities as part of govt’s polio eradication programme

Shardul Nautiyal, Mumbai
Tuesday, July 9, 2019, 08:00 Hrs  [IST]

The National Authority for Certification of Poliovirus Containment (NAC) under the Indian Council of Medical Research (ICMR) has called for applications by August 07, 2019 to recognise and certify Poliovirus Essential Facilities (PEFs) in the country as part of polio eradication programme. Government of India established NAC in August 2017.

Poliovirus vaccine manufacturers, R&D laboratories, diagnostic and testing laboratories and diagnostic reagents manufacturers are a few examples of laboratories requiring to continue to handle poliovirus type 2 in post-eradication periods.
 
As per the Union Health Ministry's mandate, only the certified PEF will be permitted to continue work with poliovirus type 2 in India. NAC will follow the globally accepted protocol for facility certification as described in World Health Organisation (WHO) Containment Certification Scheme (CCS).

Government’s polio immune strategy is aimed to make a switch over from trivalent oral polio vaccine (OPV) to bivalent oral polio vaccine (OPV) in a phased manner to completely stop OPV and switch to inactivated polio vaccine (IPV) by 2020.

The trivalent OPV that was used till April 2016 contained three types of poliovirus vaccines (P1, P2 and P3) and protected against all three types of wild polioviruses – type 1, type 2 and type 3, while bivalent OPV contains two types of poliovirus vaccines (P1 and P3) and protects against type 1 and type 3 wild polioviruses. Type 2 component from OPV was removed as a part of global polio end game strategy.

Therefore, organisations retaining Poliovirus type 2 materials (wild, vaccine and/ or genetically modified strains) or PEFs are required to obtain certificate of compliance in line with requirements of polio virus containment envisaged under the Global Action Plan III (GAP III) and WHO CCS.

Eradication of wild poliovirus type 2 was certified in September 2015. Global withdrawal of OPV2 (Sabin2 vaccine) was achieved in April 2016. Since the poliovirus type 2 (prototypes, wild poliovirus isolates, vaccine strains and their derivatives) are under containment as described in GAP III. Poliovirus type 2 is now an eradicated pathogen.

As per the ICMR notice, completed application form with supporting documents should be submitted to Dr. Nivedita Gupta, member secretary, NAC, Division of Epidemiology and Communicable Diseases, ICMR, New Delhi.

The applications for containment certification submitted by the PEF will be reviewed by the NAC. Comments or recommendations made by NAC will be discussed with the containment working group of the Global Certification Commission (GCC).

Applications will be considered for "Certificate of Participation" and bio-risk management system audit will be conducted as per the recommendations of NAC. Cost of conducting bio-risk management system audit will be borne by the applicant organization.

“Certificate of Participation” will be valid for one year. During this one year period the PEF will be expected to prepare for full "Containment Certification" of the facility.

Polio Eradication Endgame Strategic Plan - GAP III to minimise facility associated risk of poliovirus reintroduction, post-eradication and containment certification scheme (CCS) provides the steps to be undertaken by member states of the World Health Assembly (WHA) to achieve the goal of global polio eradication and certification.

 

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