Dr Roderico H. Ofrin, WHO Representative to India, said, “The WHO plays a pivotal role in supporting countries in strengthening their regulatory systems, and promoting equitable access to quality, safe, efficacious, and affordable medical products and health products.”
“This is indeed a great achievement, and we would like to congratulate the Ministry of Health and Family Welfare and its affiliated institutions,” he added.
Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India), Central Drugs Standard Control Organization, highlighted that “India, as a large vaccine producing country, is currently supplying several vaccines to the UN agencies (UNICEF, WHO and PAHO).
“National Regulatory Authority of India meets the standards of the WHO NRA indicators (WHO Global benchmarking Tool) on functional regulatory system for vaccines” he added.
Welcoming the positive outcome of international benchmarking, Dr Alireza Khadem, WHO Team Leader for the NRA Re-benchmarking, said, “It will go a long way in re-affirming India’s role in global health, including the strength of its pharmaceutical sector and drug regulatory capacity.”
“WHO had scaled up its technical support to the India’s national regulatory authority over the past several years. This success is a culmination of intensive effort by the Health Ministry, including CDSCO, in collaboration with WHO, to implement a roadmap to strengthen capacity for regulation of vaccines.”
India is a major vaccine producer that has 36 major vaccine manufacturing facilities. These vaccines are used for the national and international market (150 countries), which makes India a major vaccine supplier across the globe.
The WHO Prequalification Programme (PQP) is aimed at facilitating access to vaccines that meet unified standards of quality, safety and efficacy as well as programme needs. It is also prerequisite for manufacturers to supply to countries through United Nations procuring agencies. A functional NRA is a criterion for WHO prequalification of vaccines
