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Biotech company accused of illegal medical trials

Gulf News

The federal environment ministry's genetic engineering approval committee (GEAC) wants in investigation into an allegation that the Hyderabad- based Shantha Biotechnics illegally manufactured recombinant streptokinase used to treat heart problems and did clinical trials on humans, causing the deaths of some patients.

The GEAC said in New Delhi Shanta carried out trials of r-streptokinase on patients without its approval and wants the firm probed by the Drug Controller General of India.

Shantha's executive director Khalil Ahmed however denied the charge saying his firm had the DCGI's approval for clinical trials and therefore did not require a separate clearance from GEAC.

"We even gave them DCGI's letter and will be submitting that and more documents again. The department of biotechnology under the ministry of science and technology is the nodal agency for all biotech companies and clearly said no prior approval of GEAC is required for clinical trials."

The firms conducted trials on about 120 to150 patients simultaneously with another firm. "Two of their patients and one of ours died. We did a double blind clinical trial earlier this year, under which the identify of the drug is revealed only after the test is conducted. The one fatality was revealed when we gave reports of the tests to DCGI. In fact, AB-LE, the biotechnology initiative of the Confederation of Indian Industry has demanded that GEAC be restructured because it is not qualified to sit in judgment on any biotech product."

In Vizianagaram, officials threatened to take the firm which supplied fungus infected ring lactate solution to the government hospital, to court. Three of seven bottles had fungus and were detected by an alert operation theatre worker before they could be used on patients.

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