CDSCO passes WHO standards, expected to boost Indian vaccine exports

December 23, 2012

WHO (World Health Organization) has approved that India’s national regulatory authority — Central Drugs Standard Control Organisation (CDSCO) — and its affiliated institutions meet the prescribed international benchmarks.

What does this move mean?

India, with 12 major manufacturing facilities, is a major vaccine producer and exporter of vaccine to nearly 150 countries. Two-thirds of the vaccines produced in India are exported. Every second child in the world is vaccinated for measles using a vaccine produced in India.

WHO assessed India’s National Regulatory Authority (NRA) — the CDSCO — and its affiliated institutions against 7 important indicators and marketing authorization and licensing, post-marketing surveillance, including adverse events following immunization and so on.

Passing this teat means that 12 private vaccine manufacturing units from India are eligible and retain the pre-qualification status for supplying vaccines to international bodies like the WHO, UNICEF and the World Bank.
WHO pre-qualification is a guarantee that a specific vaccine meets international standards of quality, safety and efficacy.
It is expected to boost investment in the pharmaceutical sector and increase exports, which touched $13 billion in 2011 and is expected to touch $26 billion in 2012.

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