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Insights into Editorial: WHO congratulates India on successful assessment of India’s National Regulatory Authority



Insights into Editorial: WHO congratulates India on successful assessment of India’s National Regulatory Authority



WHO has completed the assessment of the status of the Indian vaccine regulatory system against WHO NRA Global Benchmarking Tool (GBT) for benchmarking and measured the maturity of the system. The successful outcome of the WHO conducted assessment of the National Regulatory Authority (NRA) of India is a big boost to the Government’s efforts towards quality healthcare, for which the Government is committed to.

The World Health Organisation (WHO) has given the Indian vaccine regulatory structure the highest possible rating of 4 on a majority of parameters. The rating is higher than the one the organisation gave India in 2012, the last time it assessed the systems and processes of the country’s vaccine regulatory mechanism.


What are National Regulatory Authorities?

NRAs are defined by the WHO as “national regulatory agencies responsible for ensuring that products released for public distribution (normally pharmaceuticals and biological products, such as vaccines) are evaluated properly and meet international standards of quality and safety”.

In India’s case, the NRA, as defined by the WHO, comprises the Central Drugs Standard Control Organisation (CDSCO), which has regulatory control over the import of drugs, approval of new drugs and clinical trials; the State Drug Regulatory Authorities; the Pharmacovigilance Programme of India (PvPI), the country’s national drug safety programme; and the Adverse Events Following Immunization (AEFI) structures at the central and state levels.


What did the WHO assess, and how?

A team of experts in multiple disciplines drawn from the WHO’s Geneva headquarters, its India Country Office, and national regulators of the US, Italy, Germany, the Netherlands, Indonesia, Thailand and Egypt, assessed the National Regulatory Authorities (NRA) of India.

According to the WHO, while all countries need to have a functional NRA, it is absolutely critical for those that produce vaccines, either for their national populations or for export. These countries need to have 6 clear control functions, and the wherewithal to enforce them. These are:

  • Published set of requirements for licensing.
  • Surveillance of vaccine field performance.
  • System of lot release.
  • Use of laboratory when needed.
  • Regular inspections for GMP (good manufacturing practices).
  • Evaluation of clinical performance.


The Indian NRA was assessed on nine functions. These were:

  • Quality of the national regulatory system.
  • Registration and marketing authorisation.
  • Vigilence
  • Laboratory access and testing.
  • Regulatory inspection.
  • Clinical trial oversight.
  • NRA lot release.
  • Licensing premises.
  • Market surveillance and control.


India’s performance:

The assessment has been done in respect of 9 different functionalities and Indian NRA has been declared ‘functional’ with a maturity level of 4, i.e. the highest level as per currently evolved definitions in respect of 5 functions, and maturity level 3 in respect of 4 functions.

While maturity level 4 indicates good results and sustained improvement trends, maturity level 3 reflects systematic process-based approach, early stage of systematic improvements, data availability regarding conformance to objectives, and existence of improvement trends.


But what does a rating of 4 really mean?

In simple terms, it means that India has been classified as a stringent regulator of vaccines alongside developed countries such as the US, Japan and EU member states.


Need for assessment:

A fully functional NRA is a prerequisite for WHO prequalification of vaccines. One of the requirements to become eligible and retain prequalification status is to have the National Regulatory Authority (NRA) assessed as functional against WHO-published NRA indicators.

  • The WHO Prequalification Programme facilitates access to vaccines that meet unified standards of quality, safety and efficacy, as well as programme needs. Vaccine manufacturers can only apply for WHO vaccine prequalification if the NRA meets the standards of the WHO-published NRA indicators, i.e., the WHO Global Benchmarking Tool on the functional regulatory system for vaccines.
  • Besides, the exercise updated the Institutional Development Plan of the CDSCO and other involved affiliated institutions to address existing and/or potential gaps, and to build upon the strengths of the existing vaccine regulatory system.


How this assessment helps India?

The total value of vaccines manufactured by Indian companies is estimated to be in the range of $ 900 million. About 65%-70% is exported — India is a major player in the vaccine supply chain to agencies such as UNICEF, the WHO and the Pan American Health Organisation (PAHO). The share of the private sector in the total volume of vaccines exported is roughly around 40%. The once neglected vaccine market is now considered a source of steady income. This assessment helps India establish itself as a trusted market for vaccines.


Way ahead:

WHO accords high importance to equitable access to quality, safe, efficacious, and affordable medical and health products. In view of India being one of the main global suppliers of drug and biological medicinal products including vaccines, medical devices, and traditional medicines, and as it is supplying several vaccines to UN agencies, the ‘successful assessment will go a long way in strengthening global confidence in medical products from India’.