The three-member expert committee set up by the Health Ministry to investigate the alleged deaths of six children in Andhra Pradesh and Gujarat who were administered the controversial Human Papilloma Virus (HPV) vaccine is yet to submit the final report even after 10 months and the delay has drawn flaks from the Parliamentary committee attached to the ministry.
Though committee had earlier recommended inquiry by a premier agency into the issue, the government had set up an expert panel only. “The Committee is not aware about the date of setting up of the panel. However, absence of any specific time-line for submission of report of the panel makes the Committee somewhat apprehensive,” according to a recent report by the Parliamentary committee.
“The Committee, therefore, recommends that every effort should be made to expedite the report of this Committee so that real facts about the HPV Vaccine trial are made known without any further delay and corrective measures not only in respect of this case but for all such ongoing/proposed clinical trials of drugs/vaccines are taken. The Committee also recommends that the Department should at least now work in close coordination with other concerned departments/organizations to undertake a comprehensive analysis of the process of granting permission to research studies having hazardous effects on health and put in place a fool-proof system for pre-empting unethical research studies,” it said.
“PATH in partnership with State Governments of Gujarat and Andhra Pradesh was implementing an operational research study related to cancer of the cervix prevention in India. ICMR is providing technical support & consultation for development of protocol and plan of monitoring. The study utilized both the brands of HPV vaccine available in the market (Gardasil by Merck in Andhra Pradesh; and Cervirix by GSK in Gujarat),” according to the Action Taken Report submitted by the Health Ministry to the Panel on its earlier recommendations.
“In view of certain complaints received, the State Governments have been advised not to carry out further vaccination till further orders. To ascertain the facts of the matter, the Union Health Minister appointed a Committee comprising of Dr S S Agarwal, former director, Advanced Centre for Training, Research, Education on Cancer, Dr S P Aggarwal, former DGHS and Dr Sunita Mittal, HoD, Obstetrics & Gynaecology, AIIMS to investigate ethical issues raised in this matter,” the ATR said.
The Parliamentary Committed had taken serious view of procedural and ethical lapses on the part of the Ministry and sought the matter of allowing trial of the vaccine as also the approval for its marketing in the country to be enquired into by a premier investigating agency and to take further appropriate follow-up action in the matter. It also recommended to the Department of Health Research that in future all guidelines and norms should be adhered to before allowing trials of any drug including vaccines on Indian population. The Committee also suggested that the Drug Controller General of India should observe optimum precautions and follow all norms and guidelines while allowing marketing of any drug including the vaccines in the Indian market.
PATH (Programme 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.