India`s vaccine regulator passes strict WHO efficacy test

New Delhi: 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.


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