Genetic Engineering Approval Committee (GEAC) is all set to move against marketing of the clot buster drug, Shankinase of Shantha Biotech, without taking its approval. A top official of GEAC said, "if the product is already launched in the market by the company, it is a complete violation of the existing guideline and we will have to take necessary action to stop the same."
Shantha's application, submitted for the permission for commercial production and marketing on August 28 to GEAC, is yet to be put up in the clearance committee meeting as there was a complaint pending with the committee regarding the drug's clinical trials.
The official said that the company's application is not even considered for discussion as the committee's investigation on the adverse reports of the product's clinical trials is still going on. The sources said that the company applied for the permission as the DCGI approval letter had specifically mentioned that the marketing approval is being granted provided the GEAC gives its due approval.
The GEAC sources added that the company was supposed to apply for production and marketing approval to the DCGI and the GEAC simultaneously, it's application to the GEAC came only after the DCGI approval for marketing. Even though Shantha was questioned by GEAC for not seeking the permission from both the authorities simultaneously, the company replied that they came to know about it only from the DCGI letter, the sources said.
However, Nitin Deshmukh, director general, Association of Biotechnology Led Enterprises (ABLE), while talking to Pharmabiz said that Shantha Biotech has already received the GEAC permission for commercial production. ABLE recently stated that the GEAC clearance is compulsory for the commercial production of any biotechnology product in the country.
Shantha Biotechnics, had announced the national launch of its brand of clot-buster drug, Streptokinase, christened as 'Shankinase' on 19 October, this year. In the launching ceremony at Hyderabad, the company's managing director, Varaprasad Reddy has also stated that the product is the first indigenously developed Streptokinase drug using recombinant technology and would be affordable for millions of cardiac patients in the country.