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Hyderabad , Nov. 28

SHANTHA Biotechnics Pvt Ltd on Friday asserted that it has followed full regulatory procedures as specified by the Department of Biotechnology (DBT) in getting its recombinant clot-buster drug - Shankinase - approved for clinical trials and also subsequent clearance for manufacturing.

Responding to the news reports that clinical trials had been conducted without prior approval from the Genetic Engineering Approval Committee (GEAC), the company's Managing Director, Mr Varaprasad Reddy, termed the press release issued by GEAC as `mischievous and misleading'.

Admitting the three deaths in clinical trials on 134 patients with myocardial infarction when administered Shankinase in double blind trials, Mr Reddy said, "It has to be noted with responsibility that the patients who are administered Streptokinase are patients with acute myocardial infarction (heart attack) and there is an acceptable efficacy benchmark (60 to 70 per cent) seen throughout the world with this product."

According to Mr Reddy, since this was a drug for an emergency situation for seriously unhealthy patients, some deaths were bound to occur in any large-scale trial. "It is for this very purpose that the ethical committee of the Principal Investigators chose to conduct a comparative double blind clinical trial so that all biases could be eliminated. Thankfully, because of this decision by the investigator, you would see that the results submitted by the Principal Investigators have been accepted by the Drug Controller General of India (DCGI)."

Mr Reddy told reporters that DCGI advisory committee approved all clinical trials after the Institutional Biosafety Committee and Review Committee on Genetic Manipulation duly approved it.

Shantha's drug was approved by DCGI for phase-III clinical trials in various centres across the country. Randomised 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 to the International innovator brand of streptokinase, Mr Reddy said.

According to him, the conclusion of the investigators, which was signed and submitted to the DCGI, stated that the product generated results that were `absolutely satisfactory and safety was comparable' to the international brand. "The trials data was submitted to the DCGI as per the correct procedure and found satisfactory and approval was granted for manufacturing," Mr Reddy said.

Mr Reddy said the Principal Investigators recommended the product for the clearance of DCGI only after having satisfied that the deaths in both the groups - Shankinase versus International brand - were not clinically relevant and attributable to the drug.

"The clinical efficacy of the product is examined only by the DCGI. The role of GEAC is to comment only on the environmental impact due to the manufacturing of the product. The clinical efficacy of the product does not fall under their purview," Mr Reddy said.

Stating that the Association of Biotechnology led Enterprises, a CII outfit, has been advocating the cause of safe clinical trials for both indigenous and imported drugs, Mr Varaprasad Reddy said the association has been urging the total revamp of GEAC.

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