(a) whether the Government has approved the vaccination of Human
Papilloma Virus (HPV) anti vaccine through the Non-Governmental Organisations;
(b) if so, the details thereof and the benefits accrued thereby;
(c) whether any deaths caused by the improper application of the vaccine have been reported in
the country;
(d) if so, the details thereof;
(e) whether clinical trials of the vaccine have been conducted in the country; and
(f) if so, the details thereof and if not, the reasons therefor?
THE MINISTER OF STATE FOR HEALTH & FAMILY WELFARE(SHRI S. GANDHISELVAN)
(a) to (f) Two imported brands of Human Papilloma Virus (HPV) vaccines namely “Gardasil†(imported by M/s MSD Pharmaceuticals , Gurgaon) and “ Cervarix†(imported by M/s GSK
Pharmaceuticals, Mumbai), were allowed to undergo clinical trial (Phase III) in India, before
granting permission to import and Market Authorization. For assessing the health services
needs and preparedness for introducing Human Papilloma Virus (HPV) vaccines into the health
services in future,PATH, an international NGO, was given permission for a post licensure
observational study of HPV vaccination in Khammam district (Andhra Pradresh) and Vadodara
district ( Gujarat).The study by PATH, was recommended by the Ethical Committee
and Advisory Groups at State and Central level. Indian Council of Medical Research, an
autonomous body under the Ministry has provided technical support for the development of
protocols, and advised on ethical issues as per Govt. of India guidelines.Four deaths in the
target of 14019 in Andhra and two in the target of 10,686 in Gujarat have been reported from
among the children who were administered these vaccines. The cause of deaths was determined as
viral fever, drowning, suicide, severe anaemia with malaria and suspected snake bite.Based
on the concerns on these deaths, States have been advised not to carry out any further
vaccinations at present.