Clinical trials must come under Drugs Authority: Health experts

The “monitor” for drug experiments on humans should come under the drug regulatory authority, top health officials have decided. The Clinical Trials Regulatory Division (CTRD) should not be a separate entity but must come under the Cosmetic, Devices and Drugs Authority (CDDA), a meeting on January 25 chaired by Health Ministry Secretary Dr. Ravindra Ruberu has decided, a source said.

This decision which had the support of all those present at the meeting is to be conveyed to the Legal Draftsman who is currently formalizing the Clinical Trials Bill, the Sunday Times understands.
The meeting had also discussed the need for the final draft of the Clinical Trials Bill to be distributed among experts before it is put to the Cabinet for approval for presentation in Parliament, another source added.

Among those present at the meeting were Prof. Asitha de Silva, Professor of Pharmacology, Ragama Medical Faculty; Prof. Narada Warnasuriya, former President of the Sri Lanka Medical Association; Dr. Janaka Munasinghe, Clinical Pharmacologist at the Medical Research Institute; Prof. S.D. Jayaratne, Chairman of the State Pharmaceuticals Corporation; Dr. Hemantha Beneragama, Director of the CDDA; Dr. Priyadarshanie Galappathy, Senior Lecturer in Pharmacology, Colombo Medical Faculty; and Dr. Udaya Ranawaka, Senior Lecturer in Neurology, Ragama Medical Faculty, it is understood.

Serious concern has been expressed by experts that only a “final synopsis” of the Clinical Trials Bill has been circulated which indicated that the monitor for drug experiment applications would be the CTRD, functioning separately, which would approve and inform the CDDA, which would just be a “rubber-stamp” licensing body.

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