Mumbai: The drug controller general of India (DCGI) has approved the nation’s first gastroenteritis vaccine that has been in trials since 2005.
Developed by GSK Biologicals, the biotechnology arm of British drug giant GlaxoSmithKline Plc., the vaccine is likely to hit the market shortly, after it receives import clearances. Marketed as Rotarix, the vaccine is used to ward off rotavirus-infected diarrhoea in infants and children under five.
New cure: Rotavirus is the biggest cause of fatal gastroenteritis in children, accounting for 20% to 70% hospitalization worldwide.
Rotavirus is the most important cause of severe life threatening gastroenteritis in children, accounting for 20% to 70% hospitalization worldwide. In India, the incidence of rotavirus diarrhoea varies from 5-70%, according to a study report of Indmedica, a journal for practising doctors.
“There was a delay in receiving additional data on clinical trials from the applicant,” said M. Venkateswarlu, the drug controller. “The department has now cleared the vaccine.”
“We have received the marketing approval for our rotavirus vaccine Rotarix,” confirmed a GSK India spokesperson. “However, the entire approval process required to launch the product is not yet complete. The vaccine is long awaited in India and it should be launched as early as possible.”
Developed in 1997, Rotarix is the first human rotavirus vaccine available in the world. The US drug maker Merck & Co. Inc.’s Rotateq, which is currently undergoing trials in Africa and a few other Asian countries, is based on a bovine strain.
Rotarix received approval in Mexico in 2004 and, subsequently, in a dozen Latin American countries, as well as Philippines and Singapore.
Glaxo hasn’t yet set the price for the vaccine in India.
There are no vaccines or anti-viral drugs available for rotavirus-infected diarrhoea in India though some paediatricians and microbiologists say that a symptomatic diarrhoea treatment is preferred for such conditions.
Dr M. Kalyani, a professor in the department of microbiology of Chettinad Medical College & Research Institute in Chennai, conducted a study of diarrhoea among children under five years of age in Tamil Nadu with special reference to Rotavirus. “An anti-viral treatment is not required for infant and child diarrhoea,” says Dr Kalyani. “It is a self-limiting disease that is cured with normal fluid treatments in three days if hospitalization is not required and maximum a week in cases where hospitalization is required.”
According to her, immunization is useful for controlling potential outbreak, especially in places where hospitals are inaccessible.
At least two million hospitalization cases of diarrhoea are reported every year in India and deaths, due to lack of treatment, top 150,000 annually. Two out of five instances of diarrhoea in children can be traced to rotavirus infection.
Two other rotaviral diarrhoea vaccines—116 E and I321—developed locally have completed human clinical trials. They are made by Hyderabad-based Bharat Biotech International Ltd.