Shantha Biotechnics' plan to market its indigenously developed recombinant streptokinase in the domestic market may be indefinitely delayed as the Genetic Engineering Approval Committee (GEAC) has refused permission to start its commercial production.

GEAC rejected Shantha's application for the second time last week seeking permission for commercial production of Shankinase, its recombinant streptokinase. The company was asked to produce an affidavit/certificate to prove that it has not yet started production of the drug.

However, Dr Varaprasad Reddy, managing director, Shantha Biotechnics, alleged that the GEAC is acting with vested interests for deliberately delaying the launch of the product. "Though the company has followed all the legal and official formalities in seeking the approval for the commercial production of the product, the committee has been keeping it on hold unnecessarily," he said.

Though the company had applied to the GEAC for permission to commercially manufacture the product on July 11, 2003, which was received on August 22, 2003 by GEAC, the committee refused considering the same as they received a complaint about the clinical trials of the drug. Hence, the GEAC had sent a show cause notice to the company.

According to Dr Reddy, although the company had sent its clarifications on its stand on the clinical trials, the GEAC has not yet responded to it officially. "Moreover, GEAC did not allow him or the company officials to represent its case personally despite repeated requests so far," he informed. Reddy added that he had also sent several reminders to GEAC in this regard. "It is really unfortunate that we have not got any reply so far and we are anxiously looking forward to the justice. In the absence of clearance from GEAC, the vested interests are posting the letters to all the cardiologists stating that Shankinase was rejected by government agencies and that the product is not recommended for use. This kind of campaign will really hurt the prospects of this research product," says Dr Reddy.

In the meanwhile, after the GEAC meeting on November 27, 2003, it had issued a release through the PIB stating that the committee has viewed with concern, reports of manufacturing of recombinant Streptokinase by M/s Shanta Biotechnics Pvt. Ltd., Hyderabad and the trial of the same on patients in Hyderabad without the prior approval of the GEAC. "GEAC requested Drugs Controller General of India (DCGI) to conduct a full inquiry into the incident and into the report of deaths of some patients. A final view on what action needs to be initiated against the erring company will be decided after getting all reports," the PIB release stated.

However, replying to a Pharmabiz query in this regard, Dr Ranjini Warrier, additional director, GEAC, ministry of Environment and Forests, said that they have received the DCGI report on the issue and also the letters from the company. "We have already communicated to the company about the rejection of the application. However, the DCGI report and the responses from the company will be put forward to the views of the next committee meeting and a decision will be taken accordingly," she informed.