Dharmesh Vasava, 22, one of volunteers for a biostudy carried out by Sun Pharmaceutical Industries Ltd for the depression medication citalopram, has been admitted to hospital with pneumonia.
The company claimed in a press release issued on Tuesday that to the best of its knowledge, the infection has not been caused by the test medicine nor was it caused at the company's labs.
Vasava was one of the 14 volunteers for a bioequivalence study for the widely used antidepressant citalopram in August this year. He had been explained the trial protocol in local language as per the international good clinical practice (GCP) guidelines, after which he also signed a consent letter, in the local language. He had also been screened using a large number of tests in order to determine whether he was suitable for the study. All case papers required for the study were maintained. The biostudy was done as per the existing rules and regulations in the country.
The bioequivalence study was done in the company's clinical research labs attached to a major hospital in Baroda. The 28 bed clinical lab facilities include ECG, cell analyser, X ray, blood chemistry, urine analyser, eliza reader, patient monitoring facility and emergency medical facility. A pantry and recreation area is also attached so that volunteers can be kept for 24 hour observation.
This facility has been approved by the office of the Drug Controller General of India (DCGI). The center was recently audited by an international auditor prior to applying for international approval. All the required permissions are in place, and GCP and ICH norms are followed, the company said.
In all, 60 studies involving a total of 650 volunteers have been done at this centre, and no volunteer related problems have been reported so far. During the bioequivalence studies, the company's citalopram brand was compared with the international brand with regard to blood levels, distribution in the body, metabolism and excretion from the body. A single 40mg dose was used, while the maximum dose approved internationally is 60mg.
Citalopram has been in use for more than 5 years and in more than 20 countries with several hundred prescriptions filled. Citalopram is not reported to have caused liver or kidney damage or pneumonia. Citalopram brands, approved by the drug authorities, have been available in the Indian market for more than 7 months now, and no major side effects have been reported.
Vasava volunteered for this study on August 9 and August 24, along with 13 other people. He was physically examined and found to be in good health before the study. On each date, one puncture was made in a vein, and a vein canula was inserted, from which blood was withdrawn at repeated intervals (totally not exceeding 120ml) as per the protocol of the study.
It was observed that Vasava had a small inflammation on his hand. The study physician then prescribed him anti-inflammatory medicine before discharge- which he may or may not have taken.
Three days after the completion of the study, Vasava was admitted to the local civil hospital in Bharuch. Since the infrastructure was not adequate to treat him in Bharuch, he was shifted to a private critical care center in Baroda. The company is paying for his treatment. He was last reported to be progressing satisfactorily, although still on a ventilator.