CDSCO team recommends health ministry to cancel registration of one unit in China
June 26, 2012, 0800 IST – Source : Pharmabiz News
The three-member team of the Central Drugs Standard Control Organization (CDSCO), which had audited four manufacturing units in China in February this year, had recommended to the union health ministry to cancel the registration of at least one of these units as it was not found in proper condition.
The three-member delegation, consisting of Dr S Eshwar Reddy, assistant drug controller, CDSCO New Delhi; B Kumar, assistant drugs controller, CDSCO sub-zonal office (Chandigarh) and Dr C Sokhey, senior scientist at National Institute of Biologicals (Noida), inspected a total of four manufacturing units in China, during their visit to China from February 11 to 22 this year. They had inspected three API units and one diagnostics unit.
According to sources, the CDSCO team has submitted its detailed report to the health ministry in which it has recommended to cancel one unit as they have found several anomalies in the unit. However, the official refused to reveal further details.
This is the second time that the Union health ministry has sent its team to China for auditing and inspection of manufacturing units there. As part of its efforts to ensure that only quality products are sourced by Indian companies from abroad, the health ministry had earlier last year started the process of auditing and inspection of manufacturing plants outside India. The first delegation was sent to China in May last year in which the delegation had inspected five manufacturing units there. Though the delegation was to inspect six units, one unit did not allow the delegation to inspect their unit.
The introduction of auditing and inspection of foreign manufacturing facilities by the Indian drug regulators was a long awaited practice, especially in the wake of the fact that even though the government had made registration of imports of drugs and pharmaceuticals into India made mandatory way back in 2003, it failed to bring the desired results as the inflow of inferior raw materials into the country refused to subside.
It was under this background that the ministry earlier last year decided to introduce the practice of inspection of foreign manufacturing facilities.
During the second delegation, the inspections were carried out in China only and the plans to inspect manufacturing plants in Italy has again been deferred. Earlier, the ministry had elaborate plans to start the new practice with one country each in Europe and Asia — Italy in Europe and China in Asia.