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Bangalore , Dec. 8

THE biotechnology industry association has taken up the cause of Shantha Biotechnics and said the Hyderabad-based company did not err over regulatory matters, as alleged, in the conduct of clinical trials of its recombinant streptokinase meant to fight clots.

ABLE, the Bangalore-based Association of Biotechnology Led Enterprises, said it has taken a serious note of the recent media release issued by the Ministry of Environment and Forests seeking to probe Shantha's conducting of the trials for its drug, Shankinase.

It said it believed that Shantha had not deviated from any of the procedures laid down by the Drugs Controller General of India (DGCI) or the Review Committee on Genetic Manipulation (RCGM).

The ABLE President, Ms Kiran Mazumdar-Shaw, said, "Shantha had conducted the clinical trials for Shankinase as per the guidelines laid down by the Department of Biotechnology (DBT) where both the relevant approving bodies, the genetic review committee and the Drugs Controller General, had accorded the necessary permission. The Genetic Engineering Approval Committee's (GEAC — The Ministry of Environment and Forests body) approval is required only for the commercial manufacture of the product and, therefore, the press release commenting on the clinical trials was creating confusion for the nascent biotech industry."

The association has started interacting with the central agencies on this. It has already presented its stand to the Ministry and asked for clarity about the roles of each of the regulatory agencies, the ABLE Director-General, Mr Nitin Deshmukh, told Business Line.

The controversy was a setback to the development of the country's research based biotech and pharmaceutical industry, which is already going through inordinate delays for product approvals, he said.

The drug regulator, the association said, had approved phase 3 clinical trials of Shankinase and the trials were conducted as per the Drugs Controller General-approved protocols. According to the biotechnology department procedures, "The GEAC is not involved in granting approvals for clinical trials and, therefore, the press release stating that Shantha was conducting clinical trials without the prior approval of the GEAC is misleading."

The association said the Drugs Controller General, after examining trial data from various national centres, had approved Shankinase subject to the final approval from the GEAC. The clinical efficacy and all related risk parameters are examined by the Drugs Controller General on a scientific basis through experts from reputed medical institutions before granting approval.

Shantha's drug has also been blamed for eight deaths that occurred during the trials.

On this, ABLE said that according to biotechnology experts, there were certain inherent risks in administering a drug under trial for an emergency situation such as acute myocardial infraction or heart attack. The protocol contains acceptable efficacy benchmarks set in advance accounting for possible fatalities.

Shantha, it said, had earlier clarified that its product met these benchmarks and the results submitted by the principal investigators were accepted by the DCGI and the product was approved.

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