NEW DELHI: Taking serious note of alleged death of seven tribal girls in Andhra Pradesh, Telangana and Gujarat during clinical trials of a cervical cancer vaccine, the Supreme Court on Tuesday asked the central drug control authority and Indian Council for Medical Research to tell how permission for human trial of the drug was given.
A bench of Justices Dipak Misra and V Gopala Gowda summoned the files relating to grant of permission for conducting clinical trial of a cervical cancer prevention vaccine in 2012.
The bench also asked the Centre to produce all files relating to grant of licence for trial of the vaccine to prevent human papyloma virus (HPV) which causes cervical cancer. The drug is produced by pharma majors Glaxo Smithkline and Merck. The court asked relevant files to be produced on October 28.
Dealing with a set of two PILs on clinical trials, the court wondered how a drug was licensed to be sold in India by the Drug Controller General of India (DCGI) and ICMR, even though it had allegedly caused death and severe ailments to tribal girls.
It said, "We are concerned whether before drug was accepted to be used in India and whether DCGI and ICMR had followed procedure for its introduction." Counsel for petitioner, senior advocate Colin Gonsalves and Anand Grover, referred to an August 30, 2013 report by the parliamentary standing committee that painted a dismal picture of drug trials in India.
The bench asked the Centre to detail an action taken report on the recommendations by the parliamentary standing committee.
The bench also sought responses from Andhra Pradesh, Gujarat and Telangana, which had granted permission for the trial.
It asked the states to explain why tribal areas were selected for trial and whether proper monitoring of the trial was done by following the laid down procedure. It also asked them to explain whether the procedure was followed in taking the consent of the girls, some of whom were minors, and what medical aid was given by the state to the affected girls.
Posted by:-Indian Biological Sciences and Research Institue, NOIDA
A bench of Justices Dipak Misra and V Gopala Gowda summoned the files relating to grant of permission for conducting clinical trial of a cervical cancer prevention vaccine in 2012.
The bench also asked the Centre to produce all files relating to grant of licence for trial of the vaccine to prevent human papyloma virus (HPV) which causes cervical cancer. The drug is produced by pharma majors Glaxo Smithkline and Merck. The court asked relevant files to be produced on October 28.
Dealing with a set of two PILs on clinical trials, the court wondered how a drug was licensed to be sold in India by the Drug Controller General of India (DCGI) and ICMR, even though it had allegedly caused death and severe ailments to tribal girls.
It said, "We are concerned whether before drug was accepted to be used in India and whether DCGI and ICMR had followed procedure for its introduction." Counsel for petitioner, senior advocate Colin Gonsalves and Anand Grover, referred to an August 30, 2013 report by the parliamentary standing committee that painted a dismal picture of drug trials in India.
The bench asked the Centre to detail an action taken report on the recommendations by the parliamentary standing committee.
The bench also sought responses from Andhra Pradesh, Gujarat and Telangana, which had granted permission for the trial.
It asked the states to explain why tribal areas were selected for trial and whether proper monitoring of the trial was done by following the laid down procedure. It also asked them to explain whether the procedure was followed in taking the consent of the girls, some of whom were minors, and what medical aid was given by the state to the affected girls.
Posted by:-Indian Biological Sciences and Research Institue, NOIDA
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