GEAC's ill-directed rebuke
a communication gap between the Genetic Engineering Approval Committee (geac) and Department of Biotechnology (dbt) recently triggered a controversy involving an indigenous drug for acute myocardial infarction (heart attack).
The geac ticked off Hyderabad-based Shanta Biotechnics Private Limited, the developer of the drug, for undertaking the clinical trials of the medicine without its permission. What complicated matters further were the deaths of some patients who had been given the drug. But a spokesperson of Shanta Biotech contends that the company did not seek the geac's approval as the rules stipulating this had changed.
Shanta Biotech is the first Indian pharmaceutical company to have developed the drug recombinant Streptokinase. The medicine, which has been named Shankinase by Shanta Biotech, can dissolve blood clots in the arteries.
In a reprimand issued on February 3, the geac said it "condoned the procedural lapse by (the company) with a strict warning". Shanta Biotech had received the clearance for phase-iii clinical trials from the Drug Controller General of India. However, what caused the misunderstanding was a letter issued on May 7, 2002, by the dbt directing the company to get an approval from the geac. While the dbt subsequently revised this order, the geac asserts that it was not intimated about the change. The confusion has been cleared now. geac member secretary Ranjini Warrier told Down To Earth that the body has decided to recognise the company's clinical trials.
Regarding the death of six patients, Varaprasad Reddy, managing director, Shanta Biotech, explains that either Shankinase or an international brand was administered to 134 people. Three patients who died had taken Shankinase, while the other three had consumed the international brand. This proves that Shankinase meets the global efficacy benchmark for the product, claims the company.
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