The WHO NRA re-benchmarking, scheduled from 13 to 17 February 2017 is aimed to assess and document the status of the India vaccine regulatory system, re-benchmark the status of the India vaccine regulatory system against the WHO NRA Global Benchmarking Tool (GBT) and measuring the maturity of the system.
It will update the Institutional Development Plan of the India Central Drugs Standard Control Organization (CDSCO) and other involved affiliated institutions to address existing and/or potential gaps and build upon the strengths of the existing vaccine regulatory system.
The last WHO assessment (benchmarking) of the Indian vaccine regulatory system was conducted in 2012 by an international team of experts. During the aforementioned assessment, an institutional development plan (IDP) and the road map for strengthening the NRA of India were developed to address the identified gaps. Based on this IDP, several capacity building activities were undertaken by WHO in the past years. As part of the re-benchmarking process, the observed audit was planned and conducted in October 2016. In addition, pharmacovigilance field visits were conducted in two states in India - Madhya Pradesh and West Bengal in December 2016.
The World Health Organization (WHO) plays a pivotal role in supporting countries in strengthening their regulatory systems and promoting equitable access to quality, safe, efficacious, and affordable medical products and health products. Recently, a World Health Assembly resolution (WHA67.20) on regulatory system strengthening emphasized the WHO mandate and requested both WHO and Member States to invest more in this area and to address all health products and technologies.
The outcome of the NRA assessment of 2017 is a step forward in re-affirming the joint mutual strategic priority of WHO with India, of supporting an improved role of India in global health by strengthening the pharmaceutical sector, including strengthening drug regulatory capacity.