A panel comprising medical experts would be constituted to inquire into the allegations of procedural lapses in the drug trials held at the King George Hospital (KGH) in the past, HRD Minister Ganta Srinivasa Rao said here on Monday, after holding discussions with KGH Superintendent G. Arjuna and Andhra Medical College (AMC) principal P.V. Sudhakar.
“The panel will submit its report in a month. Similar trials were held at hospitals across India and certain guidelines were fixed by the Drugs Controller General of India (DCGI) and the Ethics Committee. The records of trials conducted in the past were not maintained,” he told the media.
Referring to the row over the death of Rama Rao (45) last year, who had underwent drug trials, the Minister said that the post-mortem report had revealed that it was a ‘natural death’. “Appearing of ‘adverse reports’ in a section of media was unfortunate. The committee will probe into the alleged lapses and procedural deviations,” he said.
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Clinical trials!
However, the KGH authorities said that the tests conducted on patients were ‘clinical trials’ only, not ‘drug trials’ as alleged. “While drug trials are conducted to check the efficacy of new drugs, clinical trials are conducted to standardise the dosage of already proven drugs to treat different types of diseases,” Dr. Arjuna said, replying to queries posed by the media.
Rama Rao was admitted to the nephrology ward with complaints of high BP, diabetes and others. It was a double blinded clinical study, he said. “The report received from the Forensic Science Laboratory (FSL), Hyderabad, had declared the cause of death as ‘broncho pnuemonia’ and there was no poisoning due to the drug. Hence, it was declared as ‘natural death’,” Mr. Arjuna said and attributed the delay in the release of report by the FSL to ‘technical reasons’.
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Missing records
On the allegations of non-availability of records of past clinical trials held in the hospital, Dr. Arjuna said that old records were misplaced during the Hudhud cyclone in Oct 2014. To another query, he said: “The new Ethics Committee, which was constituted recently, does not seem to know that it’s unethical to go to the media, without first informing the Principal and me.”