Biotech firms seek pre-qualification from WHO
(ECONOMY BUREAU – Financial Express -November 05, 2005)
NEW DELHI, NOV 4: India’s biotech companies including Bharat Biotech, Shantha Biotechnics and Serum Institute have approached the World Health Organization (WHO) for pre-qualification certificates for new combination vaccines. If these companies get the world body’s nod, they would be able to export these products to global markets, currently dominated by MNCs like GlaxoSmithKline. The WHO approval would enable the companies to respond to the United Nations’ tenders for vaccine procurement.
The global vaccines market is currently valued at $3.6 billion, and the combination vaccine segment is expected to be the growth driver in the years to come.
India has the advantage of low cost production and inceasing acceptance of the manufacturing units by reputed global regulators like US-FDA and the European authorities.
Speaking to FE, Varaprasad Reddy, CEO, Shantha Biotechnics said the company was awaiting the WHO approval for a pentavalent combination vaccine. “Once we get the approval, we will have access to a $40-50 million market, facilitated by the WHO nod,” said Mr Reddy. The Hyderabad-based company is currently conducting advanced clinical trials for the Hib vaccine, which also is likely to be included in the combination vaccine with hepatitis A, B and tetanus vaccines
What The Nod Means
• If these companies get the world body’s nod, they would be able to export these products to global markets
• The WHO approval would enable the companies to respond to the UN tenders for vaccine procurement
• The global vaccines market is currently valued at $3.6 billion
• The combination vaccine segment is expected to be the growth driver in the years to come
India’s biotech vaccine market has a size of Rs 300 crore at present and is growing at over 30%. Domestic vaccine manufacturers depend on government procurement to push volumes. Apart from the vaccines for diphtheria, tetanus, whole-cell pertussis vaccine (DTP), polio, small pox, hepatitis B vaccine has recently been included in the mandatory vaccination list.