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Cover Story
India's vaccine checks
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Not good enough, says WHO
2001: India's Drugs and Cosmetics Act is amended to meet international standards; inclusion of National Regulatory Authority (NRA)
and WHO's Good Manufacturing Practices (GMP). NRA is a body that, among other things, inspects whether vaccine manufacturers follow
WHO's GMP
2004: WHO inspects public sector vaccine manufacturing units
August 2004: Amended Drugs and Cosmetics Act comes into force
August 2007: WHO inspects again, says NRA has not ensured GMP compliance
September 2007: Health ministry conducts meeting to discuss WHO report. Asks public sector unit (PSU) heads to come up with a plan
to create new facilities and create buffer stocks
December 2007: Secretary, health and Drugs Controller General of India, make a presentation to WHO in Geneva on action taken. They
assure WHO if the units don't comply, the licences would be revoked
January 2008: Health ministry team inspects the units
January 16, 2008: Licences suspended
February 6, 2008: Ministry decides not to use existing stock of vaccines
April 2008: Ministry's expert committee assesses PSUs
September 18, 2008: Based on the committee report, additional secretary of health ministry assigns alternative uses to the units
Tags: Cover Story, Drug Industry, Drugs, Health, India, Ministry Of Health And Family Welfare, Public Sector, Vaccination, WHO
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