Last week another controversy over clinical trials of a new drug in India was reported by Pharmabiz.com and some financial dailies. In this case, a Hyderabad-based NGO had alleged that eight people had died during the clinical trials of recombinant streptokinase (shankinase) launched by Shantha Biotechnics a month ago. The NGO had also stated that the company had shifted its trial site from Hyderabad to Bangalore during the trial period following reports of deaths. Shantha is the second company in India to launch the recombinant version of the drug. Bharat Biotech International was the first company to launch the product in India. The market for streptokinase in India is estimated at Rs 65 crore and the demand is expected to grow at the rate of 25 to 30 percent. The NGO's allegation against the company was duly taken note of by the Genetic Engineering Approval Committee under the ministry of Environment & Forests. GEAC in a press release said that Shantha has not taken mandatory clearance from it before approaching DCGI for clinical trials. The Committee has taken serious objection to Shantha's bypassing of GEAC at its meeting held on November 27 and asked DCGI to initiate a detailed inquiry into the episode. DCGI clearance for conducting clinical trials and marketing recombinant products should come only after GEAC gives a go ahead to the clinical trials.

Shantha's managing director, Varaprasad Reddy was quick to respond to the media reports by saying that GEAC has no role in granting approvals for clinical trials for this drug as per the protocols of Department of Biotechnology. He said that all clinical trials are approved by DCGI Advisory Committee after they were approved by Institutional Biosafety Committee and Review Committee on Genetic Manipulation. Mr Reddy may be right when he says that GEAC has no role in granting approvals for clinical trials for his drug as per the DBT's protocols. In fact, that is what the officials at the DCGI also say. Officials, quoting the Drugs and Cosmetics Act, point out that there is no mention of this requirement in the Act to seek an approval from GEAC for trials. An interesting fact here is that DCGI is also a member of GEAC. Seeking a GEAC clearance before approaching DCGI for clinical trials of a new biotech drug is a practice followed by most of the biopharmaceutical companies in the country. It may not be without a reason that the government has laid down such a lengthy procedure involving three to four agencies while granting marketing permission for a new biotech drug. The whole episode brings to the fore the need for clear cut guidelines with respect to the approval and conduct of clinical trials of drugs, particularly biopharmaceuticals, in the country. The demand of the Association of Biotechnology led Enterprises to establish a single body for approval of clinical trials, in this regard, could bring an end to this regulatory confusion exists between various central government agencies.