RJD MP Sudhakar Singh Moves Supreme Court Seeking CBI Probe Into Gates Foundation-Funded HPV Vaccine Trials

The criminal writ petition under Article 32 of the Constitution alleges grave constitutional violations, illegal human trials on tribal girls, regulatory failures, and the creation of an unconstitutional “parallel administration” through foreign-funded policy influence in India’s health and governance sectors.

Filed through Advocate-on-Record (AoR) Amit Dwivedi and a legal team led by Advocate Satyam Singh Rajput, the petition has been registered before the apex court.

At the heart of the plea are allegations surrounding HPV vaccine trials conducted between 2007 and 2010 in Andhra Pradesh and Gujarat on approximately 25,000 to 32,000 tribal girls aged between 10 and 14 years. The vaccines involved were Gardasil, manufactured by Merck & Co., and Cervarix, developed by GlaxoSmithKline.

The petition relies extensively on the findings of the 72nd Parliamentary Standing Committee Report on Health and Family Welfare (2013), which had sharply criticised the conduct of the trials.

According to the plea, PATH initiated the trials even before the vaccines had received marketing approval in India from the Central Drugs Standard Control Organisation (CDSCO). Gardasil was approved only in July 2008 and Cervarix in September 2008, despite the project having commenced in 2007.

The petition further alleges large-scale violations of informed consent norms, claiming hostel wardens and school principals were made to sign consent forms on behalf of minor girls and that several forms bore signatures dated after vaccination had already occurred. It also raises concerns over the deaths of seven minor girls during the course of the trials, alleging that no proper independent investigation or autopsy was conducted and that the deaths were summarily declared “unrelated” to the vaccines.

The plea seeks registration of an FIR or Regular Case by the Central Bureau of Investigation against PATH officials and public servants associated with the Indian Council of Medical Research and the Drug Controller General of India (DCGI). Alternatively, the petitioner has sought constitution of an SIT headed by a retired Supreme Court judge to conduct an independent probe.

Beyond the vaccine trial allegations, the petition accuses the Gates Foundation of exercising excessive influence over Indian policymaking through Project Management Units (PMUs) and Technical Support Units (TSUs) functioning across sectors such as health, nutrition and agriculture.

The plea describes these arrangements as an unconstitutional “parallel administration” operating outside democratic accountability and alleges that PATH functioned in India for years without mandatory clearances from the Ministry of External Affairs and Ministry of Home Affairs.

The petition also seeks a fresh independent inquiry into the deaths of the seven girls, monetary compensation for their families, criminal prosecution of all individuals found responsible, and creation of a nodal regulatory mechanism to oversee operations of foreign non-commercial entities in India.

Additionally, directions have been sought to involve the National Human Rights Commission (NHRC), National Commission for Protection of Child Rights (NCPCR) and National Commission for Women (NCW) in examining the alleged violations of child rights, women’s rights and human rights arising from the trials.

Addressing concerns over delay, the petition argues that the alleged violations constitute a “continuing wrong” since the deaths remain uninvestigated, no criminal proceedings have been initiated and compensation has not been paid despite recommendations made by the Parliamentary Standing Committee more than a decade ago.

The matter is expected to be listed before the Supreme Court for preliminary hearing in the coming days.