Hyderabad based Shantha Biotechnics has asserted that it followed full regulatory procedures as specified by the Department of Biotechnology in getting its recombinant clot-buster drug - Shankinase - approved for clinical trials and subsequent clearance for manufacturing. It termed the press release issued by Genetic Engineering Approval Committee (GEAC) as mischievous and misleading.
Responding to the reports that clinical trials had been conducted without prior approval from GEAC Varaprasad Reddy, managing director, said, "According to the Dept of Biotechnology protocol, GEAC has no role to play in granting approvals for clinical trials. All clinical trials are approved by DCG (I) Advisory Committee, after Institutional Biosafety Committee (IBSC) and Review Committee on Genetic Manipulation (RCGM) have duly approved them.
According to the company, Shankinase was approved by DCG(I) for Phase III clinical trials in various centers across India. Randomized multi-centric double-blind comparative trials were conducted in Hyderabad, Bangalore, Pune, Lucknow and Mumbai, in which the safety and efficacy of Shankinase was compared with the International innovator brand of streptokinase. "The conclusion of the Investigators, which is signed and submitted to the DCG(I), states that the product generated results that were absolutely satisfactory and safety was comparable with the international brand. The trials data was submitted to the DCG(I) as per the correct procedure and found satisfactory and approval was granted for manufacturing." He said.
Regarding the comments on the reported deaths occurring during the trials, Mr. Varaprasad Reddy said that, "All the data pertaining to the clinical trials were reviewed by the ethics committee, which constituted of all the Principal Investigators of the Trial. Having satisfied themselves that the deaths in both the groups (Shankinase vs. International Brand) were not clinically relevant and attributable to, the drug was recommended and signed for submission to the DCGI. The DCGI was given the entire Dossier about the trial and they have reviewed it and approved it for manufacturing, subject to approval from GEAC, Ministry of Environment and Ministry." He explained.
According to Reddy, the clinical efficacy of the product is examined only by the DCG(I). The role of GEAC is to comment only on the environmental impact due to manufacturing the product and Clinical Efficacy of the product does not fall under their purview.