Law of Medicine

Indigenously Made Rotavirus Vaccine Received WHO Pre-qualification

24.01.2018

WHO “pre-qualified” the ROTAVAC vaccine, developed by the Hyderabad-based Bharat Biotech Limited. Now, the vaccine can be sold internationally to several countries in Africa and South America. It is a low-cost vaccine developed indigenously to protect against a deadly virus that kills about half a million children around the world every year and is rampant in Asia and Africa. ROTAVAC was developed as a result of a multi country - multi partner collaborative efforts for over 2 decades. This large public private social innovation partnership included the Government of India's Department of Biotechnology (DBT), the Indian Council of Medical Research, the Indian Institute of Science (IISC), the All India Institute of Medical Sciences (AIIMS), Christian Medical College (CMC) Vellore, King Edwards Memorial Hospital (KEM) Pune, and others.

The World Health Organisation estimates that, Rotavirus is a leading cause of severe diarrhoea in children below five and India accounts for 22 percent of deaths caused due to rotavirus diarrhoea worldwide. As per a recent study published in an international non-profit organization, PATH, 37 percent of the 578,000 childhood diarrheal deaths in 2013 were due to rotavirus, for a total of 215,000 rotavirus deaths globally. More than 90 percent of these deaths occurred in low-resource countries. ROTAVAC was licensed by the Drugs Controller General of India in the year 2014. India began a phased introduction of the vaccine in its national immunization program from 2016. Bharat Biotech a Hyderabad based company has supplied approximately 30 million doses of ROTAVAC to the Indian government till date and is aiming to providing ROTAVAC at an affordable price to public-sector markets globally to ensure that, the vaccine is accessible to all children in low-resource countries. It is estimated that, every child in the world will become infected with Rotavirus, if not vaccinated.

The development of the rotavirus vaccine would further inspire and promote high-end research and development not only in medical science, but also in other advanced areas of science and technology and an effective Public-Private-Partnership model for finding affordable solutions to societal challenges. It is noteworthy that, the development of ROTAVAC is also an evidence of a growing drug development sector in India. After a rigorous regulatory process, WHO granted pre-qualification for ROTAVAC.

Tags : Vaccine Pre-qualification Grant

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