A World Health Organization (WHO) led team of international experts from several countries has affirmed that the National Regulatory Authority of India (NRA) and affiliated institutions meet the WHO published indicators for a functional vaccine regulatory system.
The WHO NRA re-benchmarking exercise, from 13-17 February 2017, was aimed at assessing and documenting the status of the India vaccine regulatory system, re-benchmarking the status of the India vaccine regulatory system against the WHO NRA Global Benchmarking Tool (GBT), updating the Institutional Development Plan and measuring the maturity of the system.
Speaking about this landmark development, Mr C.K. Mishra, Secretary Health, Health & Family Welfare, Government of India said that the Central Drugs Standards Control Organization, in collaboration with WHO, has made exemplary efforts towards this achievement.
“India is one of the largest manufacturers and exporters of vaccines world-wide; this development further deepens our resolve to maintain the highest quality and efficacy of the products that are manufactured within our country and in this context, we look forward to strengthening our collaboration with WHO,” he added.
Welcoming the positive outcome of international assessment, Dr Henk Bekedam, WHO Representative to India said, “It will go a long way in re-affirming India’s role in global health, including the strength of its pharmaceutical sector and vaccine regulatory capacity.”
“WHO had scaled up its technical support to the India’s national regulatory authority over the past several years. This success is a culmination of intensive effort by the Health Ministry, including CDSCO, in collaboration with WHO, to implement a roadmap to strengthen capacity for regulation of vaccines. WHO will continue to support development of the NRA through technical advice, training and capacity building,” he added.
India has shown a high commitment and a strong political will to strengthen and build capacity of the NRA. In this context, the renewed confidence in India’s NRA allows the domestic vaccine manufacturers to apply for WHO vaccine prequalification programme. It also allows export of Indian vaccines to the world immunization market, and will probably lead to more affordable vaccines. The development is also supportive of the ‘Make in India’ initiative.
One of the requirements to become eligible and retain the prequalification status is to have a NRA assessed as functional against the WHO Global Benchmarking Tool. Safety, efficacy and quality are three basic parameters of assessment of vaccines.
Importantly, the assessment found the vaccine regulatory system to be functional at maturity level 4 for several functions such as clinical trial oversight, marketing authorization, vigilance, lab access and lot release and at maturity level 3 for the remaining four functions: licensing of premises; market surveillance and control; regulatory inspections and national regulatory system.
As for all NRA benchmarkings, sustainability of the gains made in regulatory capacity is critical. For this purpose, the team which has just completed the assessment in India has drawn up a detailed and updated Institutional Development Plan. The plan will outline additional activities to be undertaken to further strengthen regulatory capacity in India in the coming years.
About WHO’s Prequalification Programme and NRA assessment
A functional NRA is a criterion for WHO prequalification of vaccines. The WHO Prequalification Programme (PQP) is aimed at facilitating access to vaccines that meet unified standards of quality, safety and efficacy as well as programme needs. It is also prerequisite for manufacturers to supply to countries through United Nations procuring agencies.
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.
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.