The World Health Organization has cleared India's vaccine regulatory system for maintaining international standards, paving the way for easy export of vaccines produced in the country.
The National Regulatory Authority of India (NRA) and its affiliated institutions now meet WHO efficacy indicators for a functional vaccine regulatory system, after a WHO team of international experts from eight countries conducted its comprehensive review in December last.
India's Rs 19,000-crore vaccine industry accounts for exports worth 13 billion US dollars to 150 countries. India is a major vaccine producer that has 12 major vaccine manufacturing facilities.
In 2012, India had seven vaccine manufacturers producing 67 prequalified vaccines (dosage forms). Currently 16 vaccines are prequalified by WHO and exported through United Nations agencies. More than 70 per cent of all measles vaccines used globally are produced in India.
WHO assessment of a regulatory authority as functional means the country's vaccine production lines are efficacious and safe and can easily be trusted.
"It reaffirms faith in India's regulatory system and also reiterate the country's strength in pharmaceutical sector," said Health Secretary Keshav Desiraju.
