• 15 January 2013
  • Features
  • By Manasi

India gets WHO approval for vaccine exports

In a significant boost to the vaccine industry, CDSCO recently announced that a stringent WHO audit has deemed Indian manufacturers fit to export vaccines to international markets


India gets WHO nod for the export of vaccines to international markets

A World Health Organization (WHO) team consisting of 16 experts from different nationalities have assessed the vaccine clearance procedures of the Indian Central Drugs Standard Control Organization (CDSCO) and NRA (National Regulatory Authority (NRA) and found them to be "stringent enough and (that) the international community can be assured that vaccines produced by Indian companies are of high quality, safe and efficacious." The NRA adhered to the six critical control functions laid out by WHO, thus receiving the official accreditation from the public health agency.

The stamp of approval from the WHO for the country's regulatory body comes as a welcome move, not just because it helps open up doors to Rest Of the World (ROW) markets and international aid agencies for Indian manufacturers, but also because it helps clear India's image in terms of quality of vaccines that had taken a beating in recent times. The WHO approval also holds special meaning, since India has failed the same audit which was previously carried out in 2009, not once but on three separate occasions in the past. It would also make India the first country to pass the current required norms. The Drug Controller General of India (DCGI) explicitly stated that, had Indian failed to meet the necessary criteria, it would have had to stop the export of its vaccines to over 159 countries. The audit team however concluded that more could be done in the areas of pharmacovigilance and reporting of adverse events following vaccination.

Currently, India's vaccine exports include primary ones such as those for diphtheria, pertussis and tetanus, of which India caters to 80 percent of the world's supply as well as other comparatively advanced ones such as those for hepatitis, meningitis and the pentavalent vaccines. Companies manufacture 30 different types of vaccines for domestic as well as the international use.

On receiving the approval, the Drug Controller General of India, Dr GN Singh said, "We have passed with flying colors. India has become the first country to pass the stringent indicators put in place by the WHO, in one shot. WHO has also assured us of their help in capacity building on drug regulation in India. The team has expressed total confidence in the quality of Indian vaccines being exported to all corners of the world."

A WHO endorsement remains crucial since international aid agencies such as GAVI (Global Alliance for Vaccines and Immunization), WHO and UN (United Nations) aid agencies all source their vaccine subjects to a WHO prequalification approval. Experts also hope that a WHO approval for the country's regulatory body can have far reaching implications, that might result in domestic manufacturers also adhering to the highest standards in quality. Dr Harish Iyer, CEO, Shantha Biotechnics says, "This move is very positive as it confirms that Indian vaccine manufacturers will continue to play a major role in the procurement of United Nations Agencies and emerging countries in general."


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