India´s vaccine regulatory system receives approval from the WHO
The World Health Organisation has approved India?s vaccine regulatory system that will allow India?s vaccine producers to easily export vaccines out of the country. The regulatory system passed the WHO?s international standards for efficacy indicators for a functional vaccine regulatory system based on a review by international experts.
India?s vaccine industry
India?s vaccine industry is worth Rs 19,000-crore that accounts for exports worth $13bn USD to 159 countries. India has 12 major vaccine manufacturing facilities that produce 16 prequalified vaccines in 67 dosage forms that are exported through UN agencies. The WHO acquires nearly 80% of the global supply of DPT (diphtheria, pertussis, and tetanus) and BCG (bacilli calmette-guerin) vaccines, and almost 90% of measles vaccines, from India.
How will this benefit the global vaccine industry?
In 2010 the global vaccine industry was worth $25.3bn and is has exhibited steady growth that is expected to be worth $56.7bn by 2017. Now that India has less exporting obstructions we will expect to see India play an important role in buffering supply chains and prevent vaccine shortages. For example, Sanofi Pasteur?s continuing manufacturing delays of its BCG tuberculosis vaccine, due to a manufacturing plant contamination, has contributed to a global vaccine shortage. During the same period India destroyed 27 million doses of the BCG vaccine due to product expiration. The new WHO approval of India?s regulatory system will therefore allow India to play a more dynamic role in providing vaccines to global markets.
– Jonathan Mackinnon