Pneumonia Vaccine Trial Death: DCGI Promises Action.

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http://economictimes.indiatimes..com/News/News_By_Industry/Healthcare__Biotech/Action_against_guilty_for__vaccine_trial_death_DCGI/articleshow/3998777.cms

 

Action against guilty for vaccine trial death: DCGI

 

19 Jan 2009, 0135 hrs IST, Sushmi Dey & Khomba Singh, ET Bureau NEW DELHI: The Drug Controller General of India (DCGI) has found “glaring gaps†in the clinical trials of the US-based drug maker Wyeth's advanced Pneumonia vaccine which led to the death of an infant and said action will be taken against the guilty this week.

 

"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," DCGI Dr Surinder Singh said.

 

Wyeth 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.

 

An official in the DGCI office, who didn't wish to be named, said notices would be served to the two firms and the hospital soon.

 

When contacted, Wyeth denied any wrongdoing. “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 said.

 

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.â€

 

According to her the child died due to some unrelated complications after seven days of administering 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. “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.

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