In February, the government had rolled out the vaccination drive, which offers a single dose of quadrivalent HPV free of cost to eligible 14-year-old girls to prevent cervical cancer. Gardasil 9 is a vaccine that protects against nine strains of HPV.

A 2017 report by the Global Advisory Committee on vaccine safety, which broadly held the vaccine to be safe, had observed, “Despite the extensive safety data available for this vaccine, attention has continued to focus on spurious case reports and unsubstantiated allegations.”

A Parliamentary Standing Committee report in 2013 had found “grave irregularities in the conduct of clinical trials”, leading to a halt in the rollout, according to the petitioners.

Dr Mittal and Chouksey, in their petition, highlighted that in June, Merck had publicly announced settlement of more than 200 lawsuits at a sum exceeding USD 50 million in the US alleging serious autoimmune ailments in young women owing to Gardasil, without admitting liability.

Chief Justice D K Upadhyaya and Justice Tejas Karia, addressing the government, said, “This is a very serious issue; you get yourself immunised not to get infected. We are not doubting your intentions, but it is a serious issue concerning all girl children, women at large… This is a very important issue… Vaccination is a good scheme, but if there are adverse events we need to be cautious.”

The court requested Additional Solicitor General Chetan Sharma to be briefed by officers in the Ministry of Health and Family Welfare (MoHFW) who are directly involved in the current rollout of the vaccine, and assist the court with the issue. It issued a notice to the ministry, Indian Council of Medical Research and Central Drugs Standard Control Organisation, seeking their responses to the issues raised in the PIL.

The HC will hear the case again on July 29.

The petitioners’ counsels also requested that the data on adverse events be presented before the court.

“There is no data on adverse event reporting (publicly available). There is a department (within MOHFW) that takes note of adverse events. The problem is, on an earlier occasion, in 2013, the Parliamentary committee flagged so many adverse events that the rollout was stopped. In 2026, the same vaccine has been launched… If they can at least come with the data on the adverse events among the 1.15 crore people who have been administered so far,” Kumar said.

A month ago, Secretary (Biotechnology) Rajesh Gokhale had said that a single-dose Cervavac vaccine — a made in India HPV vaccine — is being clinically tested, but is likely to be included in the national vaccination drive after 2027.

The petitioners have urged that before the rollout of a mass vaccination programme, the government must “commission or disclose a robust district-level epidemiological assessment”, which is publicly available. They added that there is a “lack of conclusive data” in India on the immunological protection provided by the vaccine.

In a factsheet, the WHO had said on July 15 that global coverage for the first dose of HPV vaccine in girls stood at 33% as of 2025. This is far below the 90% coverage targeted by 2030, although it shows an incremental increase in coverage from the 17% globally as of 2019. As per WHO, “the smaller increase in global coverage since last year was a result of new introductions and programme scale-up in several large countries, but this increase was offset by reductions in performance in some large countries.”

According to WHO, HPV vaccine was provided through national immunisation programmes and services in 162 countries in 2025, including new introductions in 15 countries. By 2025-end, 93 countries used a one-dose schedule, and globally more than 85% of girls aged 9–14 years vaccinated that year were on a single dose schedule.