The Union health ministry's second delegation to China for auditing and inspection of manufacturing plants will commence from February 12 and the three-member delegation will inspect six manufacturing units there. The delegation will be there in China till February 19.
The three-member delegation of the Central Drugs Standard Control Organization (CDSCO) consists of Dr Dr S Eshwar Reddy, assistant drug controller, B Kumar, assistant drugs controller, CDSCO sub-zonal office (Chandigarh) and Dr C Sokhey, senior scientist at National Institute of Biologicals (Noida).
According to sources, during the second visit, inspections will be carried out in China only and the plans to inspect manufacturing plants in Italy has once 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. But in the pilot project, the ministry sent the delegation to China only. The ministry has made plans to extend the auditing and inspection of all the manufacturing sites in all the foreign countries once the pilot programmes are successful.
As per the earlier plan, a three-member CDSCO delegation was to leave for China on November 20. But, the visit has been postponed to the fourth quarter of this financial year as the financial allocation of the ministry for the third quarter had finished. Now, the delegation will be going to China in the fourth quarter.
The health ministry had early last year started the process of auditing and inspection of manufacturing plants outside India as part of its efforts to ensure that only quality products are sourced by Indian companies from abroad. The first delegation was sent to China in May last year in which the delegation had inspected five pharma companies in China.
The introduction of auditing and inspection of foreign manufacturing facilities by the Indian drug regulators was a long awaited plan, especially in the wake of the fact that even though the government had made registration of imports of drugs and pharmaceuticals into India 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 these circumstances the ministry decided to introduce the system of inspection of foreign manufacturing facilities.