India's vaccine regulator passes strict WHO efficacy test

A World Health Organization team today cleared India's vaccine regulatory system for maintaining international standards, thus paving the way for easy export of vaccines produced in the country.

India's Rs 19,000-crore vaccine industry accounts for exports worth 13 billion US dollars to 150 countries across the world.

The WHO team said India's national vaccine regulatory authority, the Central Drugs Standard Control Organization (CDSCO) and its affiliated bodies met the strict WHO parameters needed to be maintained by any functional vaccine regulatory system.

At the end of a six-month review which concluded this week, the WHO team of 18
inspectors from all over the world including the US Food and Drug Administration Office certified the CDSCO and its facilities as functional, paving the way for local vaccine producers to better market their products.

In an increasingly safety conscious world, most countries necessarily import vaccines from countries where the national regulatory authorities have been tested by the WHO as functional.

WHO assessment of a regulatory authority as functional means the country's vaccine production lines are efficacious and safe and can be easily trusted.

"This is a big achievement and an important milestone for our vaccine industry," said a senior Health Ministry official.

The latest certification means all the 12 Indian vaccine makers can now apply for WHO pre-qualification and thus improve the chances of exporting their products to the first world and a range of global agencies including the UNICEF and World Bank and the Gates Foundation which only import from WHO prequalified makers.

India's last assessment was in 2009 and this time the Health Ministry officials said India had become the first in the world to have passed the WHO's very strict parameters in a single shot.

Many other countries have been given 14 weeks to improve. Back home, the size of vaccine industry is estimated to be Rs 19,000 crore. India is among the leading vaccine exporters to 150 countries and last year the exports were worth USD 13 billion.

The size would have now doubled and with the WHO of CDSCO as assessment as functional, the exports will get a major push.

Incidentally, India could not clear the strict WHO norms in 2007 leading to problems in export of local vaccines in the international market.

The WHO team visited various facilities for testing the following regulatory functions of CDSCO facilities including Central Drug Lab Kasauli which reviews every vaccine made in India – marketing authorisation, licensing, post marketing surveillance including adverse events following immunization, lot release by the national regulatory authority and lab access.