India’s national regulatory agency, the Central Drugs Standard Control Organization, recently received clearance from the World Health Organization, which could boost the country’s private vaccine manufacturing pharmaceutical companies.
India passed seven strict levels of indicators as part of an assessment conducted by a team of 12 international experts headed by a WHO member. The WHO determined the CDSCO and its affiliated institutions met the prescribed international standards, the Hindu reports.
By passing the test, India’s 12 private vaccine manufacturing units are eligible and maintain pre-qualification status to supply vaccines to WHO, UNICEF, the World Bank and other international bodies.
The clearance by the WHO could increase investments in the pharmaceutical sector. Vaccine exports in India reached $13 billion in 2011 and could hit $26 billion in 2012.
India’s vaccine are used in close to 150 countries. Every second child vaccinated for measles worldwide uses a vaccine produced in India. Two-third of the vaccines India produces are exported.
The WHO uses benchmarks to define international expectations for a functional vaccine regulatory system. The organization conducts regular external audits to ensure that national regulatory systems meet necessary standards. The WHO assessed the CDSCO and its affiliated institutions for its compliance against WHO indicators, marketing authorization, licensing and post-marketing surveillance, the Hindu reports.