The Delhi High Court on Wednesday described the Centre’s rollout of Merck’s human papillomavirus (HPV) vaccine, Gardasil, under the Universal Immunisation Programme (UIP) as a matter of serious concern while hearing a public interest litigation (PIL) that raised questions over the vaccine’s safety and sought disclosure of adverse event data.
HPV is the most common sexually transmitted infection (STI) globally and encompasses a group of more than 200 related viruses.
While many strains are harmless and clear on their own, some low-risk types cause genital warts, while high-risk types can lead to various cancers.
The PIL, filed by gynaecologist Dr Sujata Mittal and health entrepreneur Jitendra Chouksey through senior advocate Gyanendra Kumar and advocate Rohit Kumar, referred to the 2009 HPV vaccine trials conducted in Gujarat and Andhra Pradesh.
The petition alleged that the trials were followed by reports of deaths in 2010 in a village in Telangana’s Khammam district and pointed to the findings of a 2013 Parliamentary Standing Committee report, which flagged “grave irregularities” in the conduct of the clinical trials and led to the suspension of the earlier rollout.
“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,” a Bench comprising Chief Justice D K Upadhyaya and Justice Tejas Karia observed.
The court asked Additional Solicitor General Chetan Sharma to obtain instructions from officials of the Ministry of Health and Family Welfare directly involved in the ongoing vaccination programme.
It also issued notices to the Ministry, the Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organisation (CDSCO), seeking their responses to the issues raised in the PIL. The matter has been listed for further hearing on July 29.
The petitioners also urged the court to direct the authorities to place data relating to adverse events following immunisation (AEFI) on record.
Senior advocate Kumar submitted: “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… Why has Cervavac (an indigenously made gender-neutral HPV vaccine by Serum Institute of India) been ignored? HPV is not at the level of an epidemic or a pandemic to (require) release (of the Gardasil vaccine) without any data… 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.”
The Union government launched the HPV vaccination drive in February, providing a free single-dose quadrivalent HPV vaccine to eligible 14-year-old girls as part of its cervical cancer prevention programme.
Separately, Cervavac, the indigenous HPV vaccine developed by the Serum Institute of India, is currently undergoing clinical evaluation for a single-dose regimen and is expected to be considered for inclusion in the national immunisation programme after 2027.
