India admits errors in drug testing that lead to six deaths

Proper guidelines for trials of an HPV vaccine among young girls in India were not followed, the Union Health Ministry admitted this week.

Secretary Department of Health Research V. M. Katoch admitted the guideline errors to the Parliamentary Standing Committee on Health, which is headed by Amar Singh.

The guidelines state that third phase trials for any drug or vaccine cannot be conducted on children until a similar trial is held on adults. Katoch said that, in the HPV vaccine case, this rule was not followed.

Katoch also noted that the vaccine is meant to be given prior to the start of sexual activity as a means of protecting against cancer. Because of the average age of those that would receive the vaccine, it was tested on girls between the ages of 10 and 14.

The standing committee sent the matter to a premier investigating agency to determine if the testing age constituted a breach and is seeking information on appropriate follow up actions.

In the future, the committee said, all guidelines and norms must be strictly adhered to before any drug trials can be allowed.

Any drugs marketed to the Indian population, the Drug Controller General of India recommended, should observe optimum precautions while following all norms and guidelines.

The government stopped the trials of MSD Pharmaceuticals' Gardasil and GSK Pharmaceuticals' Cervarix HPV vaccines, which involved 14,019 people in Andhra Pradesh and 10,686 people Gujarat, after six children died.