India’s Vaccine Regulatory System Meets WHO Standards
The Central Drugs Standard Control Organisation (CDSCO) and the National Regulatory Authority of India (NRA) have been recognized for meeting international vaccine regulation standards set by the World Health Organisation (WHO). This announcement was made by the Ministry of Health and Family Welfare.
WHO’s Approval
An expert team from WHO conducted a thorough scientific review from September 16 to 20, approving India’s vaccine regulatory system. WHO has established global standards to ensure vaccine quality, focusing on safety, efficacy, and quality.
Benchmarking and Achievements
The WHO NRA re-benchmarking assessed India’s regulatory system using the Global Benchmarking Tool (GBT) Version VI. India was declared ‘functional’ in all core regulatory functions. The system was previously benchmarked in 2017 against GBT Version V, which has since been updated to Version VI with stricter criteria.
Statements from Officials
Punya Salila Srivastava, Union Health Secretary, praised the collaboration with WHO, highlighting India’s significant role in the pharmaceutical industry. Dr. Roderico H. Ofrin, WHO Representative to India, congratulated the Ministry of Health and its institutions for this achievement.
India’s Role in Vaccine Production
India is a major vaccine producer with 36 manufacturing facilities, supplying vaccines to 150 countries worldwide, solidifying its position as a leading global vaccine supplier.
Doubts Revealed
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.
WHO -: WHO stands for the World Health Organisation. It is a special agency of the United Nations that works to improve health and well-being around the world.
CDSCO -: CDSCO stands for the Central Drugs Standard Control Organisation. It is the national regulatory body in India responsible for approving and regulating medicines and vaccines.
NRA -: NRA stands for National Regulatory Authority. In India, it refers to the organization responsible for ensuring the quality and safety of medicines and vaccines.
Global Benchmarking Tool Version VI -: This is a tool used by WHO to assess and compare the quality of vaccine regulatory systems in different countries. Version VI is the latest version of this tool.
Generic Medicines -: Generic medicines are drugs that have the same active ingredients as brand-name drugs but are usually cheaper. They are important because they make healthcare more affordable.