India, a country forging its way into the vaccine production business, has found itself descending into the clutches of its private sector. A 2008 shutdown of government-owned vaccine manufacturing facilities has unintentionally provided a foothold for private companies such as the Serum Institute of India and Green Signal Bio Pharma to sweep in and provide doses for the nation's basic immunization program.
Prices of vaccines under the Universal Immunization Program (UIP) have doubled since 2006-07 because government vaccine institutes have failed to provide a significant amount of product. India temporarily closed three government vaccine manufacturers in 2008 after then-Health Minister Anbumani Ramadoss deemed their facilities noncompliant with good manufacturing practices. And though the institutes all reopened in February 2010, they have produced only a fraction--if any--of the doses they regularly supplied before the suspension of operation. Pasteur Institute of India in Coonoor and Central Research Institute in Kasauli have produced limited amounts of vaccine, and the BCG Vaccine Laboratory has not produced a single dose for UIP. This means the government needs to purchase routine vaccines from the private sector for its basic immunization program comprised of 6 vaccines.
What's that done to UIP's annual routine immunization budget? With the exception of the oral polio vaccine, the cost of routine vaccines added up to more than 50% of the entire budget--up from 25% of the budget in 2006-07, The Times of India reports. Pasteur Institute of India and Central Research Institute supplied more than 90% of the DPT (diphtheria, pertussis, tetanus) vaccine doses and more than 80% of tetanus toxoid vaccine used for UIP 7 years ago. Now, they together produced just 36% of the DPT vaccines used and a mere 23% of the tetanus toxoid vaccines used for the UIP. And prices of those vaccines more than doubled in that time frame; DPT vaccine jumped from Rs 12 ($0.22) to Rs 28 ($0.51) per vial of 10 doses, and the tetanus toxoid vaccine went from Rs 6 ($0.11) to Rs 15 ($0.27).
UIP needs to lean entirely on the private sector for BCG vaccine because the BCG Vaccine Laboratory isn't producing any doses. Instead, private companies Serum Institute of India and Green Signal Bio Pharma are delivering the doses. Since 2008, the price of BCG has risen from Rs 13 ($0.24) to Rs 30 ($0.54) per vial of 10 doses.
India is home to 12 major vaccine manufacturing facilities and exports to 150 countries. Much of its vaccines market--a full 65%--is made up of exports. And it's not all bad news for the government; the World Health Organization gave the country's national regulatory authority and affiliated institutions the go-ahead to supply vaccines to the WHO as well as other international bodies such as UNICEF and the World Bank. But the government will need to step up its game if it plans to compete with the private sector in an industry estimated to hit $871 million by 2016.
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