The Genetic Engineering Approval Committee (GEAC) of the Ministry of Environment and Forests has finally given clearance for the manufacture and marketing of r-Streptokinase to Hyderabad based Shantha Biotechnics Private Ltd. The GEAC approval has come after six months of Shantha announcing the national launch of the recombinant product. The decision favouring shantha came during the committee meeting held here on May 12, 2004.
The committee had earlier rejected the approval for the drug on the premise that the company had launched it without seeking mandatory clearance from GEAC for conducting the clinical trials.
Following the GEAC objection, Shantha had presented the details of clinical trials before the Committee. The GEAC had in its meeting held last month announced that the protocols approved by DCGI for conducting Phase-III human clinical trials and data generated therein would form the benchmark for the committee decision. It had asked both DCGI and RCGM of the Department of Biotechnology to go through the report submitted by the company and express their opinion. The RCGM was asked to give their report regarding the adequacy of the containment facilities at Shantha Biotechnics to meet the environmental safety regulations.
Having received satisfactory reports from both the agencies, GEAC is known to have cleared the application last week.
The objection of GEAC to the launch of Shantha's streptokinase came up during its meeting held here on November 27. It had taken serious note of the alleged "unapproved" clinical trials carried out by the company and subsequent deaths of some patients and asked DCGI to initiate a full fledged inquiry into the matter.
The company had launched its recombinant Streptokinase (shankinase), a lifesaver for Acute Myocardial Infarction patients, in October. The company had claimed that the safety and efficacy of Shankinase compared with commercially available natural Streptokinase in patients with Acute Myocardial Infarction [AMI] [i.e.heart attack] have been proven in a multi-centric double blind randomized Phase III Trial in prestigious hospitals.
The market for Streptokinase in India is valued at over Rs. 65 crores currently and is poised to grow at 25-30 per cent.