The Delhi High Court has issued notices to the Ministry of Health and Family Welfare, the Indian Council of Medical Research, and the Central Drugs Standard Control Organisation regarding the national rollout of Merck’s Gardasil human papillomavirus vaccine under the Universal Immunisation Programme.
A division bench comprising Chief Justice D. K. Upadhyaya and Justice Tejas Karia described the public health issue as serious during proceedings on a public interest litigation, emphasizing the need for caution regarding potential adverse events associated with immunisation initiatives.
The bench requested Additional Solicitor General Chetan Sharma to obtain instructions from health ministry officials directly overseeing the initiative and assist the court. The High Court has scheduled the next hearing for July 29.
Public Interest Litigation Raises Adverse Event Concerns
The petition was filed by gynecologist Dr. Sujata Mittal and health entrepreneur Jitendra Chouksey, who were represented by Senior Advocate Gyanendra Kumar and advocate Rohit Kumar. The petitioners urged the court to direct government authorities to present data on adverse events related to the ongoing vaccination drive.
Counsel for the petitioners noted that approximately 1.15 crore individuals have received the vaccine so far, yet public data regarding adverse events remains unavailable. They cited a 2009 clinical trial of the HPV vaccine conducted in Gujarat and Andhra Pradesh, which was followed by reported deaths in Andhra Pradesh’s Khammam district in 2010. The petitioners also highlighted a 2013 Parliamentary Standing Committee report that uncovered major irregularities during those clinical trials, resulting in a suspension of the rollout at the time.
National Vaccination Drive And Indigenous Options
The Union government initiated the current HPV immunisation drive in February, providing a single free dose of the quadrivalent vaccine to eligible 14-year-old girls to prevent cervical cancer. Gardasil 9, produced by American drug maker Merck, targets nine strains of HPV.
During the hearing, legal counsel questioned why the government chose to deploy the imported vaccine while bypassing Cervavac, a single-dose indigenously produced gender-neutral HPV vaccine manufactured by the Serum Institute of India. Department of Biotechnology Secretary Rajesh Gokhale stated last month that Cervavac is currently undergoing clinical evaluation and is expected to be considered for inclusion in the national program after 2027.
The petitioners maintained that human papillomavirus levels do not constitute an epidemic or pandemic that would warrant distributing the vaccine without public disclosure of safety monitoring data.
