Biocon denies deaths in trials

Biocon Limited, which is about to commercially launch its re-combatant human insulin, has become involved in a legal battle as a result of a public interest litigation (PIL) filed by a NGO, Adar Destitute and Old People Home before the Supreme Count.

The NGO alleges that there have been deaths during human trials conducted by Biocon for its human insulin product. However, Biocon has categorically denied any such deaths.

Kiran Mazumdar Shaw, chairperson, Biocon told reporters: "I will not be able to directly comment on this issue (whether the PIL will delay the launch of the product). However, I can only say that there has been no injunction against our launch."

Biocon has already signed a nine-year deal with Bristol Myers to supply the human insulin developed by Biocon. The PIL filed by the NGO alleges that two firms, Biocon and Shanta Biotechnics, conducted human trials of genetically engineered (GE) drugs without prior approval and there have been some deaths during these trials.

The Centre, which is a co-respondent to the petition, reportedly has conceded that human trials were conducted without prior approval of Genetic Engineering Approval Committee (GEAC).

But it has added that ex-post facto approval for trial for the two drugs, r-streptokinase of Shanta Biotechnics and r-human insulin of Biocon, have been granted by the committee, condoning the procedural lapse.

Clarifying Biocon's stance on this, Shaw said: "There was ambiguity on whether we have to get approval from GEAC before the Phase III clinical trials. We went ahead with the trials after we got approvals from The Drugs Controller General of India (DGCI) for clinical trials, but later we came to know that we have to get approval from GEAC, which we eventually did."

She added that Biocon had "also got approval from The Review Committee on Genetic Manipulation for our trials and all these were obtained in line with the published procedure of the Department of Biotechnology. The trials were conducted strictly in accordance with protocol based on internationally accepted standards and with the informed consent of all volunteers."