New Delhi, March 13 The nationwide rollout of the HPV vaccination campaign for 14-year-old girls was preceded by careful deliberations, training of medical staff, and guidance from the National Technical Advisory Group on Immunization, the government told the Lok Sabha on Friday.
In a written reply, Minister of State for Health Prataprao Jadhav said the preparatory work for the campaign launch took into consideration the recommendations made by scientific bodies of the world, including the World Health Organization's Strategic Advisory Group of Experts on Immunization (SAGE), the Indian Council of Medical Research (ICMR), and the National Technical Advisory Group on Immunization (NTAGI).
The nationwide Human Papillomavirus (HPV) vaccination campaign was launched on February 28 this year. The single-dose Gardasil-4 vaccine is administered free of cost at government health facilities, including Ayushman Arogya Mandirs, Primary Health Centres (PHCs), Community Health Centers (CHCs), sub-district hospitals/district hospitals, and government medical colleges.
Jadhav said that the vaccines are administered in the presence of medical officers, and the vaccination sites are linked to 24x7 Adverse Events Following Immunization (AEFI) Management Centers for prompt management of any adverse events.
While the vaccination is voluntary, parental consent is mandatory. Beneficiaries can register on the U-WIN platform. Operational guidelines for the HPV vaccination campaign have been disseminated to all states and Union Territories.
The minister noted that the actions undertaken by the health ministry consequent to the recommendations of the 72nd report of the Department Related Parliamentary Standing Committee on Health and Family Welfare on HPV vaccine trials were taken into cognisance by the committee as reflected in its 81st report.
Highlighting regulatory reforms over the last decade, Jadhav said that the New Drugs and Clinical Trials Rules (NDCTR), 2019, introduced a comprehensive regulatory framework and streamlined approval processes for clinical trials and new drugs. These rules made it mandatory for Ethics Committees reviewing biomedical research to register with the Department of Health Research (DHR).
The DHR and Central Drugs Standard Control Organization (CDSCO) have set up the NAITIK Portal and SUGAM portal for the online registration of these committees. Their composition and functions are reviewed to ensure compliance with ethical guidelines and regulations. Furthermore, the Drugs Controller General of India (DCGI) has mandated registration of all clinical trial studies on the Clinical Trials Registry of India (CTRI) portal, before participant enrolment begins.
The minister added that scientific and ethical review mechanisms before trial initiation have been strengthened. Ethics Committees are required to ensure enhanced oversight, including careful review of research proposals to ensure that risks are minimized.
The Indian Council of Medical Research (ICMR) updated its National Ethical Guidelines for Biomedical and Health Research in 2017, setting forth the requirement to ensure prior scientific validity, robust ethics committee review, risk minimization strategies, safety monitoring and oversight, and follow-up of participants to implement safeguards for the protection of research participants, including vulnerable participants. Besides, the Standard Operating Procedures (SOPs) of the Health Ministry's Screening Committee have been revised to regulate international collaborations in health research.
Jadhav clarified that since health is a state subject, state governments independently also undertake MoUs with national and international organizations on health-related matters.