The Times of India: Indore: Saturday, June 30, 2012.
The Central Information Commissioner has directed the Drug Controller General of India to provide information about clinical trial sites and hospital names where serious adverse events (SAE), including deaths, have been reported in the country including Madhya Pradesh. While hearing second appeal on the clinical trial row on Friday, the commissioner Shailesh Gandhi stated that list of SAE and deaths should be available with DCGI office and hereby directed DCGI to provide information for the year 2011 and copies of Appendix XI to the appellant before August 15.
As per the Appendix XI of schedule Y of Drugs and Cosmetic Act, there is pro forma for reporting SAE. It includes all necessary details about the investigator, the site and hospital name.
Appellant and health activist Dr Anand Rai had also asked the details of action taken against the doctors accused of conducting clinical trials in city by the Medical Council of India ( MCI). On the grounds of incomplete and unsatisfactory information provided to the appellant, the commissioner ordered PIO to pay compensation of Rs 2,000 under the Section 19(8)(b) of the RTI Act.
Earlier, the DCGI in its reply to an RTI application had answered that it did not maintain composite data of trial sites and hospital names in respective states. The RTI application was first filed in February (14/02/12) this month, which was not replied to till the end of March (28/03/12). Now, Central Information Commissioner has called the applicant and DCGI authorities with relevant documents for a second appeal hearing in New Delhi.
"Now the DCGI will have to provide information, which have not been revealed since nearly four months. Earlier, they had disposed of first appeal saying it did not maintain data of trial site and hospital name," Dr Rai said.
.JPG)
.JPG)
