National Regulatory Authority meets WHO standards
WHO approval makes way for easy export of vaccines produced in the country.
New Delhi, April 9, 2013: The World Health Organisation (WHO) has cleared India’s vaccine regulatory system paving way for the easy exports of vaccines produced in the country. The National Regulatory Authority of India (NRA) and its affiliate institutions now meet WHO efficacy indicators for a functional regulatory system post the visit from the WHO international experts from eight countries who conducted its comprehensive review in December last year.
It is worth noting here that India’s Rs 19000 crore vaccines industry currently accounts for close to exports worth US$ 13 billion to 150 countries. India is a major vaccine producer that has 12 major vaccine manufacturing facilities.
India had seven vaccine manufacturers producing 67 prequalified vaccines (dosage forms) in 2012. 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.
The approval from WHO reaffirms the faith in India’s regulatory system and at the same time reiterates county’s strength in India’s pharmaceutical sector.