India’s Vaccine Regulatory System Recognized by WHO for Excellence
The Central Drugs Standard Control Organisation (CDSCO) and the National Regulatory Authority of India (NRA) have been acknowledged by the World Health Organization (WHO) for meeting the indicators of a functional vaccine regulatory system. This recognition follows a detailed review conducted by international experts from September 16 to 20, 2024.
Benchmarking Success
India’s regulatory system was evaluated using the WHO Global Benchmarking Tool (GBT) Version VI, and it retained Maturity Level 3, achieving high marks in several areas. This marks an improvement from the 2017 assessment using GBT Version V.
Statements from Key Figures
Punya Salila Srivastava, Union Health Secretary, praised the collaboration with WHO and highlighted India’s role in the global pharmaceutical industry. Dr. Roderico H. Ofrin, WHO Representative to India, congratulated the Ministry of Health & Family Welfare for this achievement. Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India, emphasized India’s role as a major vaccine supplier.
Comprehensive Evaluation
The assessment covered various regulatory functions, including Registration and Marketing Authorization, Vigilance, Market Surveillance, Licensing, Inspections, Laboratory Testing, Clinical Trials Oversight, and NRA Lot Release.
Future Plans
To sustain and enhance regulatory capacity, a detailed Institutional Development Plan has been created. This plan outlines future activities to further strengthen India’s regulatory system.
Global Impact
India, with 36 major vaccine manufacturing facilities, supplies vaccines to over 150 countries, reinforcing its position as a key player in global health.
Doubts Revealed
WHO -: WHO stands for the World Health Organization. It is a special agency of the United Nations that works to improve health and well-being around the world.
Vaccine Regulatory System -: A vaccine regulatory system is a set of rules and processes that ensure vaccines are safe and effective before they are given to people. It involves testing, approval, and monitoring of vaccines.
CDSCO -: CDSCO stands for the Central Drugs Standard Control Organisation. It is the national regulatory body for pharmaceuticals and medical devices in India, ensuring their safety and effectiveness.
NRA -: NRA stands for the National Regulatory Authority. In India, it refers to the organization responsible for regulating vaccines and medicines to ensure they meet safety standards.
Maturity Level 3 -: Maturity Level 3 is a rating given by the WHO to indicate that a country’s regulatory system is well-functioning and meets international standards. It shows that the system is capable of ensuring the quality and safety of vaccines.
Global Benchmarking Tool -: The Global Benchmarking Tool is a method used by the WHO to assess the performance of a country’s regulatory system for medicines and vaccines. It helps identify areas for improvement and ensures global standards are met.
Punya Salila Srivastava -: Punya Salila Srivastava is a key figure mentioned in the context of India’s vaccine regulatory system. She is likely a government official or expert involved in health regulation.
Dr. Roderico H. Ofrin -: Dr. Roderico H. Ofrin is another important person mentioned. He is likely a representative from the WHO or an expert in public health, involved in recognizing India’s regulatory achievements.
