| Shantha Biotechnics today strongly refuted the statement made by the Genetic Engineering Approval Committee (GEAC), which is part of the union ministry of environment & forests, that the company had conducted clinical trials on Shankinase ( clot-buster drug Streptokinase) without its prior approval.
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| Responding to the press release issued by GEAC yesterday, which also requested the drug controller-general of India (DCGI) to conduct a full inquiry into the reported deaths of some patients during clinical trials, Varaprasad Reddy, the Shantha Biotech’s MD , said the statement was “mischievous and misleading.”
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| He asserted that the company had followed all the regulatory procedures as specified by the department of biotechnology (DBT) in getting approval for clinical trials on its recombinant Shankinase.
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| “According to DBT protocol, GEAC has no role to play in granting approvals for clinical trials. The clinical safety and efficacy of the product is examined only by the DCGI. The role of GEAC is to comment only on the environmental impact due to manufacturing of the product. All the clinical trials are approved by DGCI advisory committee after following the standard procedure,” he said.
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| On the reported death of six patients, he said that the company had conducted double blind random clinical trials on 134 patients with Myocardial infarction (heart attack) at six hospitals in five cities.
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| Under this method, the vials of the company's product and a best known international brand are masked and the identity is not known to the investigator, patient and the company.
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| “When the results were decoded, it was found that three deaths occurred in each group where Shantha brand and the international brands were administered. It is not a vaccine, which is given to healthy subjects. The patients who are administered the drug are those with heart attack, and there is an internationally acceptable efficacy benchmark of 60-70 per cent,” said Khaleel Ahmed, the ED of Shantha Biotech.
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| “We formally launched the product on October 19, but not yet commercialised it. We are waiting for the approval of GEAC for the manufacture of product. Then only we go for marketing,” Varaprasad Reddy clarified.
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| Suspecting that there is a conspiracy in this episode, Reddy said: “ We want to find out who is behind this. We will come back on it.” |
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