The office of the Drugs Control General of India (DCGI) has distanced itself from the controversy that has arisen out of the recent request of the Genetic Engineering Approval Committee (GEAC) to the DCGI, to undertake a probe into the deaths that took place during the conduct of clinical trials on the recombinant streptokinase by Hyderabad based Shantha Biotechnics. The officials responsible for handling GEAC matters in the Drugs Department have denied the receipt of any such instructions from GEAC and felt that clinical trial approvals were given as per the procedures laid out in the Drugs and Cosmetics Act.

“There is no mention of any GEAC approval in the Act. We have approved the trials after ensuring that the company has met all statutory requirements. We will not comment on any GEAC rules and you will have to contact GEAC to know about their future course of action”, officials responded to the queries from Pharmabiz.com.

When reminded about the press release issued by GEAC stating their concern on the reported incidence of deaths during clinical trials, which was conducted without their approvals, the officials said that they are not aware of any such instructions. Interestingly, DCGI is supposed to be a part of the GEAC and is expected to be aware of all its decisions. It is known that a DCGI representative was present during the last meeting of the committee held under the chairmanship of Meena Gupta, additional secretary, ministry of environment & forests.

However, sources close to GEAC informed that the committee had indeed sent a request to DCGI for which an official reply was also made by the drugs controller’s office.

It should be noted that the company, in its response to the GEAC observation, had stated that GEAC has no role to play in granting approvals for clinical trials. “All clinical trials are approved by DCG (I) Advisory Committee, after it has been duly approved by Institutional Biosafety Committee (IBSC) and Review Committee on Genetic Manipulation (RCGM)” The company had claimed. The company argument is based on the clinical trial guidelines issued by the Department of Biotechnology http://dbtindia.nic.in/policy/ggp2.html, which has no mention of GEAC approval.

GEAC on the other hand claims that there are rules which specify that “testing of genetically altered organisms, transgenic animals, plant material tested against pathogens & products in the environment should follow regulatory guidelines seeking field use permit from GEAC”.

The company press release refutes this claim and say that “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 the manufacturing of the product and clinical efficacy of the product does not fall under their purview”.

Even as the debate goes on, the issue has brought to the fore the need for clear cut guidelines with respect to the approval / conduct of clinical trials in the country. It should be noted that the newly formed Association of Biotechnology led Enterprises (ABLE), of which Shantha Biotech is a member, has been demanding a single body for the approval of clinical trials. They had been asking for a total revamp of GEAC.