New Delhi: The Union Health
ZeeNews.com
04/29/2010
Ministry has admitted that proper guidelines were not adhered to while carrying out trials of HPV vaccine among young girls in Andhra Pradesh.
The admission was made by the Secretary Department of Health Research V M Katoch to the Parliamentary Standing Committee on health, headed by Amar Singh.
When the committee drew the attention of the secretary to the DCGI (Drug Controller General of India) guidelines where under third phase trials of any drug or vaccine cannot be conducted on children until a similar trial was held on adults, Katoch admitted that the same was not adhered to in the present case.
The committee said in a report that the secretary, however, said the vaccine is supposed to be given before sexual activity begins to protect against cancer and therefore it was used on young girls aged 10-14 years.
Taking serious view of procedural and ethical lapses on the part of the Ministry, the committee sought the matter of allowing trial of the vaccine as also the approval for its marketing in the country to be inquired into by a premier investigating agency and to take further appropriate follow-up action in the matter.
It also asked that the findings of the investigating agency and the follow-up action taken in this regard may be furnished to the committee at the earliest.
The committee said in the future, all guidelines and norms should be adhered to before allowing trials of any drug including vaccines on Indian population.
It also recommended that the DCGI should observe optimum precautions and follow all norms and guidelines while allowing marketing of any drug including the vaccines in the Indian market.
The HPV vaccine trials in Andhra Pradesh and Gujarat were stopped by the government following the death of six children. The vaccines in question are Gardasil by MSD Pharmaceuticals and Cervarix by GSK Pharmaceuticals. The Phase III trials involved 14,019 in Andhra Pradesh and 10,686 people in Gujarat.
Four of the six deaths occurred in Andhra, while the other two occurred in Gujarat.
The vaccination drive was being conducted as part of a study by an NGO ‘PATH’ and was recommended by the Ethical Committee and Advisory Groups at state and central government levels.