Mumbai: After a three-year wait, GlaxoSmithKline Pharmaceuticals Ltd, the Indian arm of GlaxoSmithKline Plc., is set to launch its much touted vaccines Boostrix and Infanrix in January.

Important injection: A file picture of a boy receiving a tetanus shot. Immunity from childhood vaccination for tetanus, diphtheria and pertussis wears off after 5-10 years, leaving many adolescents susceptible.

These vaccines were expected to be launched in early 2007. While local approvals took time, uncertainty over patent protection and differential pricing in India also slowed the launch.

“The company is now gearing up for an India launch of these vaccines and the prices are going to be India specific," says GSK India spokesperson Sunder Rajan.

Boostrix, a booster vaccine for tetanus, diphtheria and pertussis (whooping cough), received approval from the US Food and Drug Administration in 2005. This vaccine is to be given as a single dose to individuals aged 10 to 18 years. Until then, there was no approved pertussis vaccine for children seven and older even as immunity from childhood vaccination generally begins to wear off after five to 10 years, leaving many adolescents susceptible to this highly contagious disease. Infanrix is a vaccine for the same diseases in children under four.

Both vaccines are protected by patents in the US and Europe but GSK is yet to get patents for them in India.

Although there are no generic version of these three-disease vaccines available in India, the Pune-based Serum Institute of India Ltd is one of the largest supplier of the combined vaccine for tetanus and diphtheria to the World Health Organization and the government of India for its public immunization programme. Serum Institute is charging about Rs1.50 per dose to these public bodies. The same vaccines are priced between Rs6-9 per dose in the open market.

The imported vaccines of GSK available in India cost between Rs1,100 and Rs1,500 per dose. GSK declined to talk about prices it will charge when the vaccines are launched in India.

In an earlier interview, GSK India managing director Hasit Joshipura said: “Our pricing models so far, wherever possible, have been India-specific and to that extent the accessibility of our drugs is pretty wide. GSK will continue to pursue India-specific models." However, he added, “it may not always be possible" to do so because of lack of economies of scale in manufacturing. GSK plans to launch a slew of products in India in the next two years from its international basket. These would include its breast-cancer drug Tykerb, a six-in-one vaccine, Infanrix hexa, and a rotavirus vaccine for gastroenteritis.