Genetic Engineering Approval Committee (GEAC) has rejected the application filed by the Hyderabad-based Shantha Biotech seeking permission for commercial production of Shankinase, the biotech clot-buster drug. Refusing the approval, the committee has asked the company to produce an affidavit/certificate to prove that it has not yet started production of the drug. The committee, which has sent an official refusal letter to the company in the second week of December, has also asked the company to declare its clear stand for not seeking permission for conducting trials of the drug.
Speaking to Pharmabiz, Desh Deep Varma, joint secretary, GEAC, said "We have sent an official letter to the company refusing the permission for commercial production of the biotech drug and also sought a certificate from them, which is to be produced immediately after the receipt of the letter to declare that the company has so far not produced the drug commercially."
Varma added that the committee has also asked the company to come for a representation to submit its position on the trial of the drug conducted without informing GEAC. "We are awaiting the company's response in this regard and in case the company fails to produce the said certificate, we may think about further course of action. The letter was sent fifteen days ago and it is not too late yet for the company to respond," he said.
However, the Shantha Biotech official when contacted replied that "we have not received any letter from GEAC whatsoever after they met on 27 November 2003." The company also said that it has not yet started commercial production of the drug and the 'National Launch,' which was announced by the company in October, was just an 'in-house function' to facilitate the scientists involved in the development and production of the drug.
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.
Earlier, Pharmabiz had reported that Shantha is yet to get approval from the GEAC for starting commercial production. That time, the GEAC official had maintained 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 the both the authorities simultaneously, the company replied that they came to know about this only from the DCGI letter, the sources said.