India’s Central Drug Standards Control Organization (CDSCO) has achieved a milestone in meeting the stringent standards of the World Health Organization (WHO) for the safety, efficacy and quality of vaccines, announced the Ministry of Health and Family Welfare. This recognition underlines CDSCO’s commitment to ensuring the safety and effectiveness of vaccines available in India. This announcement follows a comprehensive and in-depth scientific review of India’s vaccine regulatory system by a team of international experts from various countries, led by WHO. The team assessed the National Regulatory Authority (NRA) of India, comprising CDSCO, State Drug Regulatory Authorities, Central Drug Laboratory, Kasauli; Adverse Post-Vaccination Event (AEFI) structures at central and state levels, Division of Immunization, Pharmacovigilance Program of India and other relevant institutions engaged in regulation, control and testing of vaccines .

India’s vaccine regulatory system meets the highest global standards

“India has been declared ‘functional’ against all essential regulatory functions in the WHO Global Benchmarking Tool, version VI. India’s vaccine regulatory system was benchmarked in 2017 against the Global Benchmarking Tool (GBT) version V, which is now revised to GBT VI with raised bars and stringent evaluation criteria. the ministry said, adding that the country “retains maturity level 3 with the highest scores in several functions.”

WHO has established global standards and criteria to ensure vaccine quality through the development of tools and guidelines, National Regulatory Authority of India (NRA) benchmarking and to the vaccine prequalification program.

“The Central Drug Standards Control Organization, in collaboration with WHO, has made exemplary efforts to achieve this goal. India is one of the leading players in the global pharmaceutical industry and is known for its affordable vaccines and generic medicines,” said Punya Salila Srivastava, Union Health Secretary.

She also congratulated all the teams for their hard work in achieving this important milestone for the country and reaffirmed the strength of India’s regulatory system.

Additionally, to maintain the benchmark, the team that conducted the assessment in India also developed a detailed institutional development plan to strengthen the country’s regulatory capacity.

Source-IANS