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World Health Organisation

The World Health Organisation (WHO) in the third week of December 2012 approved the manufacturing practices being adopted by the private vaccine manufacturing pharmaceutical companies of India. This approval was given to Indian Pharmaceutical companies after an intensive four days audit of the vaccine manufacturing facilities across the country was concluded by a 16-member multi-nation team that was headed by WHO officials. The team comprised officials from China, EU, the US FDA, Thailand, Sweden and France.

WHO gave its clearance to the procedures adopted by the Indian National Regulatory Authority (NRA) or the Drug Controller General’s Office (DCGO). The audit team also cleared that the procedures adopted by the Central Drugs Standard Control Organisation (CDSCO) and institutions affiliated to it meet the prescribed international standards and the procedures inculcated in production were stringent enough to ensure that the vaccines produced by Indian companies were safe, high in quality and efficacious.

With this approval India became the first country in 2012 to pass the stringent levels of seven indicators that is put forward by the WHO that is made much more stringent every time conducted by a team of 12 international experts headed by a member of WHO.

India at present is a major vaccine producing country with 12 major vaccine manufacturing facilities and the vaccines formulated and manufactured in India are used in national and international markets of nearly 150 countries of the world. In case of measles every second child of the world is vaccinated using the vaccine produced in India. At present India manufactures 30 different types of vaccines that include Hepatitis, measles and polio. This approval from WHO had made the 12 manufacturing units of India eligible for supplying the vaccines to international bodies like UNICEF, WHO, World Bank, Gates Foundation, Clinton Foundation, and GAVI.


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