‘Very serious issue’: Delhi High Court flags safety issues in HPV vaccine rollout drive

A Parliamentary Standing Committee Report in 2013 had found “grave irregularities in the conduct of clinical trials, leading to a halt in the rollout of Merck’s HPV vaccine Gardasil.

Delhi High CourtThe Delhi High Court has 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, (Express/File photo)

The Delhi High Court on Wednesday termed the Centre’s decision to roll out American pharma giant Merck’s human papillomavirus (HPV) vaccine Gardasil under the Universal Immunisation Programme (UIP) “a very serious matter”, while hearing a petition flagging previous serious adverse events from the vaccine.

In a petition moved by gynecologist and obstetrician Dr Sujata Mittal and health entrepreneur Jitendra Chouksey, Senior Advocate Gyanendra Kumar, along with advocate Rohit Kumar, pointed out that an earlier attempt at rolling out the HPV vaccine in 2009 with clinical trials conducted in Gujarat and Andhra Pradesh had led to several reports of death in 2010 in a village in Khammam district in AP.

The government in February 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.

The Parliamentary Standing Committee Report in 2013 had found “grave irregularities in the conduct of clinical trials, leading to a halt in the rollout.

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 has 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 notice to the ministry, Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organisation (CDSCO), and has sought their responses to the issues raised in the public interest litigation (PIL). The High Court will hear the case again on July 29.

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

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Senior Advocate Kumar said, “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.”

The government rolled out the HPV vaccination drive in February. A month ago, Rajesh Gokhale, secretary of the Department of Biotechnology, had said that the single-dose Cervavac is being clinically tested, but is likely to be included in the national vaccination drive after 2027.

Sohini Ghosh is a Senior Correspondent at The Indian Express. Previously based in Ahmedabad covering Gujarat, she recently moved to the New Delhi bureau, where she primarily covers legal developments at the Delhi High Court Professional Profile Background: An alumna of the Asian College of Journalism (ACJ), she previously worked with ET NOW before joining The Indian Express. Core Beats: Her reporting is currently centered on the Delhi High Court, with a focus on high-profile constitutional disputes, disputes over intellectual property, criminal and civil cases, issues of human rights and regulatory law (especially in the areas of technology and healthcare). Earlier Specialty: In Gujarat, she was known for her rigorous coverage in the beats of crime, law and policy, and social justice issues, including the 2002 riot cases, 2008 serial bomb blast case, 2016 flogging of Dalits in Una, among others. She has extensively covered health in the state, including being part of the team that revealed the segregation of wards at the state’s largest government hospital on lines of faith in April 2020. With Ahmedabad being a UNESCO heritage city, she has widely covered urban development and heritage issues, including the redevelopment of the Sabarmati Ashram Recent Notable Articles (Late 2025) Her recent reporting from the Delhi High Court covers major political, constitutional, corporate, and public-interest legal battles: High-Profile Case Coverage She has extensively covered the various legal battles - including for compensation under the aegis of North East Delhi Riots Claims Commission - pertaining to the 2020 northeast Delhi riots, as well as 1984 anti-Sikh riots. She has also led coverage at the intersection of technology and governance, and its impact on the citizenry, from, and beyond courtrooms — such as the government’s stakeholder consultations for framing AI-Deepfake policy. Signature Style Sohini is recognized for her sustained reporting from courtrooms and beyond. She specialises in breaking down dense legal arguments to make legalese accessible for readers. Her transition from Gujarat to Delhi has seen her expand her coverage on regulatory, corporate and intellectual property law, while maintaining a strong commitment to human rights and lacuna in the criminal justice system. X (Twitter): @thanda_ghosh ... Read More

 

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