The National Regulatory Authority of India (NRA) and affiliated institutions meet WHO published indicators for a functional vaccine regulatory system. A WHO-led team of international experts from eight countries came to this conclusion at the end of a comprehensive review from 10-14 December 2012.
“The Central Drugs Standards Control Organization in collaboration with WHO, has made exemplary efforts towards this achievement. The Government of India has decided to further strengthen the Central as well as the State Drugs Regulatory Systems during the 12th Five Year Plan (2012-17) and looks forward to strengthening our collaboration with WHO towards this end,” said Shri Ghulam Nabi Azad, Minister, Health & Family welfare, Government of India.
India is a major vaccine producer that has 12 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. More than 70% of all measles vaccines used globally are produced in India.
Welcoming the development, Mr Keshav Desiraju, Health Secretary, Ministry of Health & Family Welfare, Government of India said, “It reaffirms faith in India’s regulatory system and also reiterate country’s strength for pharmaceutical sector.”
“WHO had scaled up its technical support to the Indian NRA over the past several months in the context of this assessment. We welcome this positive outcome. It shall go a long way in re-affirming the joint mutual strategic priority under the WHO’s new Country Cooperation Strategy with India (2012-17), of supporting an improved role of India in global health, including strengthening the pharmaceutical sector and drug regulatory capacity,” said Dr Nata Menabde, WHO Representative to India.
“This is indeed a great achievement and we would like to congratulate the Ministry of Health & Family Welfare and its affiliated institutions engaged in the regulation, control and testing of vaccines,” said Mr Lahouari Belgharbi, WHO Team Leader for the NRA Assessment, Quality, Safety and Standards Team, Department of Immunization, Vaccines and Biologicals of the World Health Organization.
With a regulatory system for vaccines assessed as functional by WHO, vaccine manufacturers in India continue to remain eligible to apply for prequalification of specific products. WHO prequalification, which is a guarantee that a specific vaccine meets international standards of quality, safety and efficacy, is a prerequisite for manufacturers to supply to countries through United Nations procuring agencies.