The three-member inquiry committee set up by the Health Ministry to investigate the deaths of six children in Andhra Pradesh and Gujarat who were administered the controversial Human Papilloma Virus (HPV) vaccine is yet to submit its report even after four months against the mandated one month.

Though report is still pending, it is learnt that the preliminary investigations found that the Drug Controller General of India (DCGI) guidelines were not adhered to in the clinical trial of the HPV vaccine. The procedural and ethical lapses were also noted in the clinical trials though it was ruled out that the deaths were due to the vaccine.

The ministry sources, however, said the details would be known only after the completion of the inquiry and the submission of the final report. "Government has advised the States not to carry out any further vaccinations on the project till further orders. To investigate the allegations of ethical violations, an independent enquiry by a committee appointed by the Minister, has been ordered. The Committee is expected to complete its work shortly," sources clarified.

But the three-member panel comprising Dr S P Aggarwal, former Director General of Health Services (DGHS), Dr Suneeta Mittal, head of the department, Obstetrics and Gynaecology at AIIMS and Ranjit Roy Chaudhury, a leading clinical pharmacologist, was formed in the second half of April with the mandate to submit the report within one month. Though four months have passed, the report is yet to be made.

PATH (Program for Appropriate Technology in Health), an International NGO, was granted permission to carry out a post licensure (operational research) study of HPV vaccination in 3 blocks each of Khammam district of Andhra Pradesh and Vadodara district of Gujarat, with the permission of State Governments of Gujarat and Andhra Pradesh. The objectives of the study are to demonstrate the suitability of vaccine delivery strategies for HPV in the 10-14 year adolescent girls, to raise community awareness of HPV, cancer of cervix and its prevention, and gaining experience in HPV vaccination and to build evidence based vaccine delivery strategy for future introduction of HPV in the Universal Immunisation Programme.

"In Andhra Pradesh among 14,091 vaccinated girls, five deaths have been reported whereas in Gujarat two deaths were reported among 10,686 girls. The causes of death among the children in Andhra Pradesh were determined as suicide (2); viral fever (1); drowning in the open well (1); and heat stroke (1). The causes of two deaths in Gujarat were suspected snake bite and severe anaemia with malaria respectively," according to the official version by the ministry.

However the deaths have caused immense row with Left leaders raising the issue in the Parliament also, after a spate of protests by the public interest groups. The Parliamentary Standing committee on Health had also taken serious view of the instance and sought that the "matter of allowing trial of the vaccine as also the approval for its marketing in the country be enquired into by a premier investigating agency and further appropriate follow up action be taken in the matter".