Responses also sought from Andhra, Guj, T for giving permission to administer vaccine
The Supreme Court on Tuesday summoned files from the Central drug control authority and the ICMR — the two agencies responsible for commissioning a cervical cancer prevention vaccine that claimed lives of six tribal girls in Andhra Pradesh and Gujarat on being administered shots of the vaccine in 2012.
The Bench of Justices Dipak Misra and V Gopala Gowda ordered the Centre to produce all files relevant to the consideration of granting license to the human papyloma virus (HPV) vaccine for cervical cancer produced by Glaxo Smithkline and Merck, the two pharma majors. The court will hear the matter next on October 28.
Dealing with a set of two PIls pending consideration with the court for the last one year, the court wondered how the drug was licensed to be sold in India by the Drug Controller General of India (DCGI) and ICMR, even as its administration caused loss of lives and severe ailments in minor girls of tribal districts in Gujarat and Andhra Pradesh (presently part of Telangana).
The order said, “We are concerned whether before the drug was accepted to be used in India, the DCGI and ICMR followed procedure for its introduction.” The petitions argued by senior advocate Colin Gonsalves and Anand Grover referred to an August 30, 2013 report by the Parliamentary Standing Committee that gave a sorry picture of how drug trials were conducted in the country. The Court asked Centre to detail about the action taken on the Parliamentary panel report.
The Bench also sought responses from the States of Andhra Pradesh, Gujarat and Telangana, which had granted permission for the trial and roped in services of a charitable foreign agency PATH to administer the vaccine. It asked the states to explain why tribal areas were selected for trial and whether proper monitoring of trials was done by way of protocol to be followed, medical aid, and consent of the girls, especially since they were minors.