The Hindu Business Line : Shanta Biotech's cardiac drug comes under scrutiny

SHANTA Biotechnics' biotech cardiac drug recombinant streptokinase has come under a cloud with the Genetic Engineering Approval Committee (GEAC) seeking a probe from the Drug Controller General of India (DCGI) into reports on deaths resulting from its clinical trials.

The GEAC, which is under the aegis of the Ministry of Environment & Forests (MoE&F), has in its meeting on Thursday expressed concern over reports of the manufacturing of recombinant Streptokinase by Shanta Biotechnics and the trial of the same on patients in Hyderabad without the prior approval of GEAC, an official communiqué said.

A probe has been sought into the matter by the Drug Controller, which is under the Union Health Ministry and a final view on what action should be taken against the "erring" company would be decided after getting the reports.

Official sources told Business Line that the drug was cleared for phase III clinical trials and a local non-Governmental organisation, Anikethan, had alleged that about eight people had died as a result of the human trials on the drug.

Further, the NGO alleged that the company had shifted its trial site from Hyderabad to Bangalore in the wake of the reports of deaths.

As a fallout of these reports, GEAC requested DCGI to conduct a full enquiry into the incident and into the report of deaths of some patients.

Further, the meeting also took up the request from non-Governmental organisation, CARE, to waive the condition of post-marketing surveillance, which was imposed by GEAC in its 34th meeting held in early November. While recommending the import of crude degummed soyabean oil for a period of one year, GEAC had stipulated that a post-marketing surveillance through the ICDS programme managers be carried out and results of the monitoring be submitted for consideration of the GEAC after obtaining the views of the Indian Council of Medical Research (ICMR).

Today's meeting deferred a decision on the issue and the GEAC decided to seek more information from CARE and the government departments concerned.

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