India’s national regulatory authority — Central Drugs Standard Control Organisation (CDSCO) — and its affiliated organisations have received clearance from World Health Organisation (WHO) for vaccine manufacturing.
The sanction by WHO promises a major boost for Indian pharmaceutical industry, as the pre-qualification is a guarantee of meeting international standards of quality, safety and efficacy. The accreditation is expected to boost investment in the pharmaceutical sector and increase exports, from $13 billion (2011-12) to touch $26 billion this year.
India became the first country in 2012 to have cleared the strict levels of seven indicators in a single round of assessment conducted by a panel of 12 international experts headed by a WHO member. In the assessment, India’s National Regulatory Authority (NRA), CDSCO and its affiliates were examined for compliance against the WHO indicators and marketing authorisation, licensing and post-marketing surveillance.
Earlier in 2007, CDSCO failed to meet the WHO-prescribed standards and manufacturing of vaccines in three public sector vaccine manufacturing units was suspended on account of non-compliance of good manufacturing practices (GMP) norms.
India is a one of the leading vaccine producers with 12 major vaccine manufacturing facilities. 12 private vaccine manufacturing enterprises are now eligible to supply vaccines and drugs to international bodies such as WHO, UNICEF and the World Bank.
Now, the vaccines can be used in the national as well as international markets, reaching nearly 150 countries.
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