The Drug Controller General of India (DCGI) is likely to re-examine the instances of alleged irregularities in the conduct of studies using Human Papilloma Virus (HPV) vaccine by international organisation, PATH, in India, in the wake of fresh report by a Parliamentary panel.
Though the Central Drugs Standard Control Organisation (CDSCO) claimed that the issue was a closed chapter as already an inquiry was done and trials were suspended, the matter may be examined again if a high-level decision is taken by the Ministry in this regard.
Sources in the CDSCO said so far, it did not have any instruction to revisit the issue and make a probe. Usually, the mandate of the CDSCO is to ensure the quality of ongoing trials and there was no need to have retrospective enquiry in this case.
With the Parliamentary Standing Committee on Health making damning observations against the authorities and the investigators on the grounds of violations of norms in the vaccine trial and the Supreme Court taking note of the matter, the issue had come up again to the limelight and the public health activists have been demanding for stern action.
However, it is learnt that the Health Ministry is yet to take any decision on what action needs to be taken next, though it has to submit its action taken report to the Parliamentary panel and also to submit the affidavit in the Supreme Court which sent notices also to the DCGI.
The Parliamentary panel had severely came down on the matter, questioning the roles of ICMR and DCGI in the trials conducted by two US-based pharmaceutical companies through PATH on tribal school girls in Khammam district in Andhra Pradesh and Vadodara in Gujarat in 2010. The trials were stopped only after the matter received media attention following the death of seven girls. The CDSCO had then also examined the issue.
In its report on “Alleged Irregularities in the Conduct of Studies using HPV Vaccines by PATH in India” presented to Parliament, the committee has said ICMR representatives apparently acted at the behest of PATH in promoting the interests of the vaccine manufacturers, and recommended that the Health Ministry review the activities of the functionaries of the Council involved in the PATH project.
In a PIL before the Supreme Court, the petitioner had alleged that trials were a clear case of child abuse and violated fundamental rights. “The anomalies in their assumed safety and efficacy were brought to the fore by various women’s groups and health groups from across the country that included a member of the National Technical Advisory Group on Immunisation,” the petition alleged.