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Strengthening India’s vaccine regulatory authority

Portrait of Dr Nata Menabde.

At the heart of WHO reform is strengthening work with countries so that they can more effectively meet technical and policy support needs. This draws on expertise from the three levels of the Organization, as well as external experts. This new way of working is demonstrated in the WHO country office for India, led by Dr Nata Menabde.

Every year, millions of patients in resource-limited countries receive life-saving quality assured medicines and vaccines that are bought through UN agencies and partnerships such as UNICEF, UNFPA, UNITAID, the Global Fund and the GAVI Alliance. In all cases, these agencies only buy products that have been through the WHO Prequalification Scheme, which ensures that medicines, vaccines and diagnostics meet international standards of quality, safety and efficacy. A key aspect of this scheme is to strengthen the capacity of national regulatory authorities, quality control laboratories, and manufacturers, so as to ensure product quality.

"Our efforts to help India strengthen its national regulatory authority are an excellent example of WHO Reform in action. It accentuates WHO's role as a leader in health issues and shows how we work across the Organization."

Dr Nata Menabde

As part of this work, WHO has recently been working to strengthen India’s national regulatory authority for vaccines. India has 12 major vaccine manufacturing facilities producing vaccines that are sold on the national and international market in 150 countries, making India a major global vaccine supplier. Nearly one third of prequalified vaccines, and over two thirds of medicines purchased through these international organizations were produced in India.

"Our efforts to help India strengthen its national regulatory authority are an excellent example of WHO Reform in action," says Dr Nata Menabde, WHO Representative to India. "It accentuates WHO's role as a leader in health issues and shows how we work across the Organization.”

With this project, the Country Office served as facilitator and technical country focal point working closely with the Government, engaging the relevant expertise from WHO's Regional Office and Headquarters, and other institutions to scale up technical support to the regulatory authority.

In December 2012, WHO led an independent assessment of the system. The result: India’s regulatory system for vaccines was assessed as functional by WHO, indicating that the country’s vaccine manufacturers remain eligible to apply for prequalification of specific products.

"In this latest assessment, we mobilized WHO experts and also brought in external assessors from Egypt, France, Indonesia, Iran, Sweden, Thailand, and the United States." says Dr Menabde. "Everyone's role and responsibilities were clearly spelled out so there was no duplication but each level provided clear added value."

This recent assessment, reviewed several functions of the regulatory system including post-marketing surveillance for adverse events following immunization; regulatory inspections of manufacturing sites and distribution channels; and authorization and monitoring of clinical trials.

The success of this assessment may lead to additional opportunities for collaboration between the Government of India and WHO – for example the provision of technical support for the development of a Comprehensive Institutional Development Plan for strengthening pharmaceuticals in India. The central level regulators who have received intensive training by WHO are now an excellent in-country technical resource. And the external experts engaged in the process have built long-term connections for additional collaboration.

"This is exactly WHO's comparative advantage: convening the relevant experts and collaborating with the Government to create the best system possible to guarantee the world's consistent access to safe, good quality, affordable vaccines and medicines," says Dr Menabde.


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