The Supreme Court Monday issued notice to the central government on a PIL seeking access to the research and other information on the PATH project on human papilloma virus (HPV) vaccine, used for preventing cervical cancer in India.
A bench of Justice K.S.Radhakrishnan and Justice A.K.Sikri issued notice.
The HPV vaccine’s clinical trial was conducted by US-based NGO Programme for Appropriate Technology in Health (PATH) in collaboration with the Indian Council for Medical Research (ICMR) and the Gujarat and Andhra Pradesh governments.
The PATH came in for severe indictment by a parliamentary committee on health and family welfare for taking advantage of the gaps in the system during the trial of HPV vaccines.
The committee also questioned the role of ICMR and that of the Drug Controller General of India.
Describing the HPV vaccines as “unproven and hazardous”, Kalpana Mehta moving the PIL said that the anomalies in the safety and efficacy of the vaccine was brought out by various women groups and health groups from across the country that included a member of National Technical Advisory Group on Immunization (NTAGI).
The petition said that both the vaccines – Gardasil, marketed by MSD Pharmaceutical Pvt. Ltd., and Cervarix by GlaxoSmithKline – were “licensed in India without sufficient clinical trials in appropriate age groups to determine their safety and efficacy”.
The petitioner has sought direction to director of Vellore-based Christian Medical College (CMC) to constitute a team comprising reputed local legal experts and NGOs to conduct a study as to the number of deaths and persons adversely impacted by the administration of the HPV vaccine by PATH and Gujarat and Andhra Pradesh by visiting the families of victims.
It has also sought direction to the CMC Vellore to determine the culpability of PATH and the Gujarat and Andhra Pradesh governments for causing adverse reaction and death in the course of the trial of vaccine and report the same to the court, including recommendations for grant of compensation and continuing their medical treatment.
The PIL has sought order restraining ICMR from entering into MOUs with pharmaceutical companies and multinational agencies and NGOs to conduct research into specific products.
It has further sought direction to ICMR to independently evaluate products and new international medical developments for their applicability and suitability in India.