The second team of drug control officials sent by the Union health ministry to inspect the manufacturing facilities in China has returned after their auditing of the plants there. The first team of officials had also gone to China for inspection last year.
According to sources, a three-member delegation of the Central Drugs Standard Control Organization (CDSCO) 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, the CDSCO team inspected three API units and one diagnostics units.
However, the CDSCO authorities did not disclose the details of the inspections carried out by the team. The delegation is preparing the details of the visit and will submit the details to the health ministry shortly, authorities said.
This is the second time that the union health ministry has sent its team to China for auditing and inspection of manufacturing units. 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 & 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.
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.