The Union health ministry's proposed second delegation to China for auditing and inspection of manufacturing plants there has been postponed due to financial constraints. As per the earlier plan, a three-member Central Drugs Standard Control Organization (CDSCO) delegation was to leave for China on November 20.

Sources said that the delegation has been postponed to the fourth quarter of this financial year as the financial allocation of the ministry for the third quarter has finished. Now, the delegation will be going to China in the fourth  quarter. However, the exact date for the foreign trip is yet to be finalised, sources added. There will be no change in the number of delegation or the number of companies to be inspected.

As part of its efforts to ensure that only quality products are sourced by Indian companies from abroad, the health ministry had earlier this year started the process of auditing and inspection of manufacturing plants outside India. The first delegation was sent to China in May this year in which the delegation had inspected five pharma companies in China.

The second three-member delegation of the CDSCO consisting of 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) was to leave for China on November 20. But, it has been held up due to the financial constraints with the ministry.

During the second delegation, the inspections will be carries out in China only and the plans to inspect manufacturing plants in Italy has 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.

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 this year decided to introduce the practice of inspection of foreign manufacturing facilities.