National Regulatory Authority of India Gets Highest WHO Ratings

The National Regulatory Authority of India (NRAI), the vaccine regulating authority of India, has been given the highest ratings by global health body World Health Organization for vaccine regulations on February 17, 2017.

• A team of international experts led by the World Health Organisation, declared that the National Regulatory Authority of India (NRA) and its affiliated institutions meets the WHO Global Benchmarking Tool requirements for a functional vaccine regulatory system.
• The WHO team of international experts conducted a comprehensive review from February 13 to 17 to measure the maturity of the system in India against WHO NRA Global Benchmarking Tool (GBT).
• The team comprised of leading experts in different areas from WHO Headquarters Geneva, WHO India Country Office, experts drawn from the regulators of USA, Italy, Germany, Netherlands, Indonesia, Thailand and Egypt.
• India has a major role in the global pharmaceutical industry covering vaccines, medical devices and traditional medicines. India currently supplies several vaccines to the UN agencies (UNICEF, WHO and PAHO).

Overview of the Assessment

WHO carried out assessment of the NRA of India comprising the Central Drugs Standard Control Organisation (CDSCO), State Drug Regulatory Authorities, Pharmaco-vigilance Programme of India (PvPI) and Adverse Events Following Immunization (AEFI) structures at the Central and States level.

• The assessment was based on nine different functionalities in the WHO Global Benchmarking Tool. These nine functions included National Regulatory System; Registration and Marketing Authorization; Vigilance; Laboratory Access and Testing; Regulatory Inspection; Clinical Trial Oversight; NRA Lot Release; Licensing Premises; and Market Surveillance and Control.
• The Global Benchmarking Tool (GBT) of WHO has 63 indicators and 288 sub-indicators, out of which 150 are critical.
• Based on the assessment, the Indian NRA has been declared ‘functional’ with a maturity level of 4 in respect of 5 functions while maturity level 3 in respect of 4 functions.
• Maturity level 4 is the highest level as per currently evolved definitions. It indicates good results and sustained improvement trends.
• Maturity level 3 indicates systematic process based approach, early stage of systematic improvements, data availability regarding conformance to objectives and existence of improvement trends.

Pre-Requisites to be Eligible for WHO Pre-qualification of Vaccines Programme

It is necessary for the National Regulatory Authority (NRA) to be fully functional against the WHO published NRA indicators for being qualified for WHO prequalification of vaccines.

• The vaccine manufacturers can only apply for WHO vaccine prequalification if the NRA meets the standards of the indicators in the WHO Global benchmarking Tool on functional regulatory system for vaccines.
• WHO Prequalification Programme provides access to vaccines that meet the unified standards of quality, safety and efficacy as well as programme needs.
• The result shows the growing maturity of the Indian NRA which has emerged from a joint effort by the Government in consultation with WHO to build capacity and capability of the National Regulatory Authority over last several years.

Need for WHO Pre-qualification of Vaccines Programme

WHO Prequalifcation, which is performed every couple of years, aims to ensure that diagnostics, medicines, vaccines and immunization-related equipment and devices for diseases with high emergency meet global standards of quality, safety and efficacy so as to optimize the use of health resources and improve overall health outcomes.

• The prequalification process consists of a transparent and scientifically sound assessment which includes document review, consistency testing or performance evaluation and site visits to manufacturers.
• This information along with other procurement criteria is then used by UN and other procurement agencies to make purchasing decisions regarding diagnostics, medicines and vaccines.

About National Regulatory Agencies

National Regulatory Agencies (NRAs) are responsible for ensuring that pharmaceuticals and biological products, such as vaccines released for public distribution are evaluated properly and meet international standards of quality and safety.

World Health Organization (WHO)

• The World Health Organization (WHO) is a specialized agency of the United Nations that is concerned with international public health.
• Formation: 7 April 1948
• Headquarters: Geneva, Switzerland
• Head: Margaret Chan, Director General