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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
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 Subject :"Action against Wyeth for death of infant: DGCI".. 2009-10-20 23:39:35 
Sushma Naidu
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Joined: 2009-07-27 17:07:19
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Hi,
NEW DELHI: The Drug Controller General of India (DCGI) has said that action will be taken against the guilty for the death of an infant during a clinical trial of the US-based drug maker Wyeth's advanced pneumonia vaccine. The company had given the clinical research contract to the domestic firm GVK Biosciences. Clinical trials took place at St John's National Academy of Health Sciences, Bangalore.

"We have found that there were glaring gaps in the clinical trial conducted for Wyeth's 13-strain variant pneumococcal vaccine. The audit report is ready and we expect to take an appropriate punitive action by this week," the DCGI Dr Surinder Singh said. An official in his office, who didn't wish to be named, said that notices would be served to the two companies and the hospital soon.

Wyeth denied the charge. "Wyeth informed the the DCGI on October 2008 about the death of the infant during the trial. This child received the course of vaccines recommended to be offered to parents by the Indian Academy of Pediatrics. This includes Wyeth's Prevenar, which has been used worldwide over the past eight years, with more than 200 million doses distributed, to protect children from pneumococcal disease. The child's vaccination was determined not to be related to the clinical outcome, nor is there any question about Wyeth's activities with regard to our sponsorship of this clinical trial. This study is being conducted in India for the benefit of children in the country. Wyeth-sponsored trials in India adhere to the same rigorous standards as Wyeth-sponsored clinical trials in any other country," Wyeth director (clinical research & development) India region, Dr Durga Gadgil told this reporter.

Explaining the cause of the child's death, she said, "The child had developed a viral infection. Experts found that this unfortunate death was not associated with any of the vaccines the child received as part of the study and the trial followed all study-related protocol. At the time of the enrolment there was no detectable abnormality in the child. ." According to her the child died due to some unrelated complications after seven days of administring the vaccine. GVK Biosciences declined to comment.

The drug quality regulator didn't disclose details about the report and the action expected to be taken against the guilty. "There are no protocols to keep checks on clinical trials and take legal action against the guilty. We can't comment on the quantum of the punishment at present as this is the very first case being audited by us," Dr Singh said. The phase-III trial was the final stage before the medicine could be launched in the domestic market. Faced with criticism, the government had initiated the audit of the clinical trial. This is the first audit in the country even as India is a hub for various types of clinical trials. The audit was done by a team of a drug regulator from the DCGI's office and a pharmacologist from All India Institute of Medical Sciences (AIIMS).
Sushma
 
 
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