In a letter to registrar state medical council issued last week, the MCI has forwarded a complaint lodged by Anil Saude, son of Chandrakala Bai, and asked the state body to investigate and take appropriate action against the doctor concerned under provisions of Indian Medical Council (Professional Conduct, Ettiquette and Ethics) Regulations, 2002.
Saude had alleged that his mother was subjected to the drug trial without consent.
Dr Bharani was the principal investigator for the trial on intravenous drug Tonapofylline in the study titled ‘Acute Decompensated heart failure (ADHF) with Renal Insufficiency” – A double blind placebo controlled study to assess the effect of intravenous Tonapofylline on body weight in subject with acute decompensated heart failure and Renal insufficiency.
The trial was sponsored by Biogen Idec Limited ,United Kingdom and Bangalore based Quintiles Research India, Saude claimed.
The complainant, who claimed to have got information about the drug trial on his mother through an Assembly question in 2012, alleged that it was conducted under the garb of medical treatment without proper consent.
“The principal investigator did not provide copy of informed consent form. The details he mentioned in the complaint were procured through RTI Act by Dr Anand Rai,” he claimed.
The doctors failed to give information to the relatives about the death due to clinical trial, Saude alleged adding no efforts were made by Dr. Anil Bharani, the investigator, for procuring and let being paid, the compensation from the Pharmaceutical Company.
The MCI has asked the MP medical council to send intimation related to Saude’s complaint to various bodies including other state medical councils in case the doctor is registered elsewhere