The Central Drugs Standard Control Organisation (CDSCO) and the National Regulatory Authority of India (NRA), in collaboration with the World Health Organization (WHO), have achieved a significant milestone by successfully demonstrating compliance with WHO's established indicators for a functional vaccine regulatory system. This determination was made by an international team of experts after conducting a comprehensive review of India's vaccine regulatory framework from September 16 to 20, 2024.

India’s vaccine regulatory system has maintained a Maturity Level 3, indicating its strong capabilities in several core regulatory functions, including registration, vigilance, and oversight of clinical trials. This achievement not only highlights the effectiveness of India's regulatory framework but also positions the country as a critical player in the global pharmaceutical landscape.

Ms. Punya Salila Srivastava, from the Ministry of Health and Family Welfare, commended the CDSCO’s efforts, emphasizing India’s substantial role in the global pharmaceutical industry, particularly in providing affordable vaccines and generic medicines. With 36 major vaccine manufacturing facilities operating across the country, India serves as a vital supplier of vaccines to over 150 countries worldwide. This vast manufacturing capability underscores India's commitment to enhancing global public health through accessible vaccination.

The WHO Prequalification Programme aims to ensure that vaccines adhere to unified standards of quality, safety, and efficacy. A functional National Regulatory Authority (NRA) is essential for achieving prequalification status, which allows vaccines produced in India to be accepted globally. The recent assessment results affirm India's ongoing commitment to bolstering its regulatory capacity and ensuring the sustainability of the gains made in its vaccine regulatory framework.

To further strengthen this framework, WHO representatives highlighted the importance of an Institutional Development Plan. This plan is designed to enhance the operational capabilities of the regulatory system, ensuring that India can continue to meet global health standards and respond effectively to emerging health challenges.

India's sustained commitment to improving its vaccine regulatory framework is crucial, especially in light of the increasing global demand for vaccines in response to both routine immunization needs and pandemic situations. By maintaining a strong regulatory system, India not only secures its position as a leading vaccine manufacturer but also contributes significantly to global health initiatives aimed at controlling infectious diseases.

As the world continues to navigate the complexities of vaccine development and distribution, India’s proactive measures in enhancing its vaccine regulatory capacity will play an essential role in shaping the future of public health. The collaboration between CDSCO, NRA, and WHO serves as a model for other countries seeking to improve their vaccine regulatory systems, fostering a more resilient and effective global health framework.

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India's achievement in vaccine regulatory compliance is a testament to its dedication to public health and global cooperation, reinforcing the nation's status as a leader in vaccine production and safety standards.