Rotavac: new era for Indian pharma

Researchers who worked on developing the rotavirus vaccine, Rotavac, deserve applause. The India-made vaccine has been awarded a 'pre-qualification' tag by the World Health Organisation (WHO), which means that the vaccine has been endorsed as safe and effective by the UN agency, paving the way for bulk procurement of the vaccine by UNICEF and other health and humanitarian agencies for use in their immunisation programmes. Rotavac is expected to provide a shot in the arm to global efforts, especially those of developing countries, in preventing diarrhoea caused by the rotavirus. India, which is already playing a major role in supplying generic medicines to developing countries, will now supply them with low-cost rotavirus vaccine. Rotavac is being described as a game changer in the fight against diarrhoea as it will make rotavirus vaccine more affordable.  While a full immunisation course of three doses of Rotavac vaccine costs just Rs 180, two other WHO-approved vaccines available in the market – global pharma giants GlaxoSmithKline's Rotarix and Merck's RotaTeq -- cost around Rs 2,500 per course. Rotrarix and RotaTeq were beyond the reach of the poor, whose children are the most exposed and susceptible to the deadly rotavirus. Rotavac's arrival in the market will hopefully change that.

Diarrhoea is the second leading cause of death among children below the age of five, and the rotavirusis responsible for an estimated 36% of hospitalisations for childhood diarrhoea globally and an estimated 200,000 deaths, most of them in developing countries. Rotavirus is a deadly killer of children in India; roughly one child in 242 dies from a rotavirus infection before the age of five. Rotavac will hopefully change this scenario. It was included in the National Immunisation Programme in 2016. India can expect to see a fall in child mortality and hospitalisation rates, thanks to Rotavac. However, Rotavac's efficacy of 55-60%, although higher than that of other available rotavirus vaccines, will need to be increased to make a major dent in child mortality rates in the country.

The development of Rotavac is an important milestone in the history of India's pharmaceutical industry. It is not the first Indian vaccine to be pre-qualified. Others have received such accreditation, too. What sets Rotovac apart is that it is a completely local formulation and development, and thus enhances the scope for credible industrial, scientific and regulatory processes to develop more vaccines in the country. India has made a name for itself for remaking existing drugs in a generic form. Now, Rotavac heralds India's arrival in the field of innovation in vaccines. Importantly, such innovation has come at contained costs. Rotavac's success should, therefore, act as a booster shot to innovation and development in India's pharma industry.