September 12, 2010
Many joint memoranda enumerating these concerns have been submitted to the Union Minister for Health and Family Welfare, demanding an immediate halt to the ‘demonstration projects’.
On April 22, 2010, the Ministry of Health and Family Welfare (MOHFW) finally conceded that the HPV vaccination project was in fact a “post-licensure operational research study.”
Further investigation confirmed it as a Phase IV, post-marketing clinical trial. On April 29, the ICMR admitted that their ethical guidelines had been flouted in the course of this trial.
The trial has been temporarily suspended by the government, and a committee has been formed to conduct an inquiry. According to V. M. Katoch, ICMR Director-General:
“This is not a phase-3 clinical trial but a post-licensure observational study as the vaccine —Gardasil by MSD Pharmaceutica l— is approved for use in India. ICMR just evaluated the study’s protocol and methodology. The state has to monitor ethical compliance but following the objection we have asked Andhra to suspend the program till a review is done.”
This paper reflects observations made by a fact-finding team of women’s rights and health activists from Sama, Jan Swasthya Abhiyan and Anthra, who visited the Bhadrachalam project site in Andhra Pradesh.