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Home News and Update Year 2010 Ministry Admits Lapses in HPV Vaccine Trial

Ministry Admits Lapses in HPV Vaccine Trial

Indian Express
29 April 2010
By Teena Thacker
New Delhi, India

DR V M Katoch, Secretary, Department of Health Research has admitted to the Parliamentary standing committee on Health and Family Welfare that Drug Controller General of India (DCGI) guidelines were not adhered to in the clinical trial of the Human Papilloma Virus (HPV) vaccine.

A committee formed by the Union health ministry to probe the alleged violation of ethical guidelines is yet to submit its report.

Taking a serious view of the procedural and ethical lapses, the standing committee has nowsoughtthatthematter“of allowing trial of the vaccine as also the approval for its marketing in the country be enquiredintobyapremierinvestigating agency and further appropriate follow up action be taken in the matter”. The trial of the HPV vaccine, used to prevent cervical cancer, was started in Andhra Pradesh and Gujarat. The administration of the vaccine, Gardasil, reportedly led to death of four girls in Khammam district of Andhra Pradesh. While the experts from the Indian Council of Medical Research (ICMR), inquiring into the case ruled out that the deaths were due to the vaccine, the Health Ministry set up the inquiry committee after CPM leader Brinda Karat raised the issue. The ICMR also suspended the programme until the enquiry report is submitted.

The three–member inquiry committee comprises Dr S P Aggarwal, former Director General of Health Services (DGHS), Dr Suneeta Mittal, Head of the Department, Obstetrics and Gynaecology at AIIMS and Ranjit Roy Chaudhury, a leading clinical pharmacologist.

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