DCI team clears Sun Pharma research facility

Chennai: A four-member high-level team comprising officials belonging to the Drug Controller General of India (DGCI), the Central Drug Standard Control Organisation (CDSCO) and the Food and Drug Control Administration (FDCA) has cleared Sun Pharma's clinical research facility located in a Baroda hospital.

The two-day inspection was carried out by the team consisting of DCGI deputy director A B Ramteke, CDSCO drug inspector D Ramkishan, FDCA commissioner Subodh Adesara and deputy commissioner H V Nakrani on 12 and 13 September 2002.

The inspection was warranted after Dharmesh Vasava, 22, a bio-study volunteer for Sun Pharma's depression medicine Citalopram, was down with pneumonia and admitted to a hospital.

According to Sun Pharma, Vasava volunteered for the bio-study on 9 August and 24 August 2002 along with 13 other people. On finding him in good health after physical examination, one puncture was made in a vein on those two days and a vein canula was inserted for extracting blood totally not exceeding 120 ml as per the study protocol.

Sun Pharma further adds that the study physician observed a small inflammation on Vasava's hand and prescribed an anti-inflammatory medicine before discharge. Subsequently, three days later Vasava went down with pneumonia.

The expert team gave their clearance after inspecting clinical research facility, the testing and analytical equipment, the analytical and validation procedures for the equipment, the procedure for the enrolment of the volunteers, the list of medical tests used for selecting and screening volunteers and the documentation procedures for recording these tests. They also checked and inspected the volunteer consent forms filled in Gujarati, and correlated these with the patient data on file.

According to Sun Pharma, Vasava could not have contracted the pneumonia infection by the test medicine nor at the company's labs as his condition now continues to be stable.