The Times of India: Indore: Thursday, June 14, 2012.
The drug regulatory authority of the country - Drug Controller General of India (DCGI), has not maintained composite data of trial sites and hospital names in respective states. This issue has come up from the DCGI office on an RTI application, which sought the details of clinical trial sites and hospital names. The first appellate authority Dr G.N Singh disposed off the application.
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, Shailesh Gandhi has called the applicant and DCGI authorities with relevant documents for a second appeal hearing in New Delhi. Meanwhile, Dr Anand Rai, RTI applicant in this case has submitted his reply citing rules of Schedule Y of Drugs and Cosmetics Act.
According to the rules, any unexpected serious adverse event occurring during clinical trial should be communicated promptly by the sponsor to the licensing authority and to the other investigators participating in the study. Accordingly DCGI receives the copies of the reports of serious adverse events(SAE). "How can first appeal be disposed off as DCGI has to maintain data of trial site and hospital name," said Dr Rai.
As per the appendix XI of schedule Y of Drugs and Cosmetic Act, there is proforma for reporting SAE. It includes all necessary details about the investigator, the site and hospital name. "It is impossible that DCGI did not maintain the required data," said Dr Rai.
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