India Meets WHO Standards for Vaccine Regulation: A Milestone Achievement

New Delhi: In a significant development for India’s healthcare sector, the Central Drugs Standard Control Organisation (CDSCO) and the National Regulatory Authority of India (NRA) have been recognized for meeting the World Health Organization (WHO) standards for a functional vaccine regulatory system. This conclusion comes after an extensive review by a team of international experts, led by WHO representatives, who assessed India’s vaccine regulatory framework from September 16 to 20, 2024.

The evaluation was part of the WHO’s re-benchmarking process aimed at documenting the status of India’s regulatory system in vaccine regulation. It was crucial in comparing the Indian vaccine regulatory system against the updated WHO Global Benchmarking Tool (GBT), now in its sixth version, which has introduced more stringent criteria for assessment.

Core Parameters of Vaccine Assessment

The evaluation focused on three essential parameters: safety, efficacy, and quality. The WHO has established comprehensive global standards to ensure vaccine quality through various guidelines and benchmarking programs. India’s vaccine regulatory system was previously benchmarked in 2017 under GBT Version V and has now successfully transitioned to GBT VI, reflecting a robust improvement in regulatory practices.

India retains a Maturity Level 3, achieving top scores in several regulatory functions. This achievement highlights India’s commitment to maintaining high standards in vaccine production and regulation.

Key Remarks by Health Officials

Ms. Punya Salila Srivastava, Union Health Secretary, expressed pride in this accomplishment, stating, “The CDSCO, in collaboration with WHO, has put in exemplary efforts to achieve this recognition. India is a vital player in the global pharmaceutical industry, known for its affordable vaccines and generic medicines.” She commended the teams involved in this endeavor for their dedication and hard work.

Dr. Roderico H. Ofrin, WHO Representative to India, noted the importance of this achievement, stating, “The WHO plays a crucial role in strengthening regulatory systems in countries, promoting equitable access to quality and safe medical products. We congratulate the Ministry of Health & Family Welfare and its affiliated institutions on this significant milestone.”

Comprehensive Evaluation and Future Plans

The regulatory functions evaluated included an overview of the National Regulatory System, Registration and Marketing Authorization, Vigilance, Market Surveillance, and several others. The WHO team has also formulated an Institutional Development Plan to outline additional activities aimed at further enhancing regulatory capacity in India in the coming years.

Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India, emphasized India’s role as a major vaccine-producing nation, supplying numerous vaccines to international bodies such as UNICEF and WHO. He reaffirmed that the NRA meets the WHO standards for a functional regulatory system.

Conclusion

This recognition from the WHO not only solidifies India’s position as a leader in the global vaccine landscape but also underscores the effectiveness of its regulatory frameworks in ensuring the safety and efficacy of vaccines. As India continues to enhance its vaccine production capabilities, the commitment to maintaining high regulatory standards will play a crucial role in global health, ensuring that safe and effective vaccines are accessible to populations worldwide.

This milestone is a testament to the collective efforts of various stakeholders in the health sector and reaffirms India’s dedication to public health and safety.