The expert committee which went into the allegations of engaging the victims of Bhopal gas tragedy for clinical trials has cited some ‘deficiencies’ in the procedures and the Health Ministry has asked for clarifications from the principal investigator Dr Pradeep Bhattacharya and the Bangalore-based firm involved in the matter, Quintiles Ltd.
The inspection of Bhopal Memorial Hospital and Research Centre was carried out in the month of October by a team of experts set up by the Central Drugs Standard Control Organisation (CDSCO) for a clinical trial titled “A phase 3, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Telavancin Pneumonia with a Focus on Patients with Infections Due to Methicillin Resistant Staphylococcus aureus’’ (Protocol No. 0015).
“Findings of the inspection showed some deficiencies for which principal investigator Dr Pradeep Bhattacharya and Quintiles Ltd., Bangalore (CRO) were asked to explain their position. Quintiles., Bangalore has already submitted its reply,’’ sources said, without giving further details into the deficiencies reported by the panel and the reply given by the investigator or the CRO.The reports claimed that the patients suffering from various ailments following exposure to Methyl-Iso-Cyanate in the Bhopal tragedy in 1984 were being used as guinea pigs at the BMHRC to test different unapproved medicines by multinational drug firms, and the issue has created furore across the country.
The research centre, set up in 2000, was also reportedly carrying out studies on long term effects of Methyl-Iso-Cyanate (MIC) poisoning, thus raking up suspicions about clinical trials by multinational companies. It was also alleged that the required code of ethics for conducting trials was being violated. The drugs allegedly used in the trials included telavancin (patented by US company Theravance), tigecycline (Wyeth), prasugrel, fondaparinux (GlaxoSmithKline) and fixed-dose combination of cefoperazone with sulbactum (Magnex) sold by Pfizer in India.However, it is not clear whether the inspection panel has listed out the names and drugs of the companies cited in the media reports.
The CDSCO authorities still maintained that they did not get any complaints, but the inspection was ordered following the media reports.
