Union health ministry will soon send a delegation from the Central Drugs Standard Control Organization (CDSCO) to China for auditing & inspection of manufacturing plants there as part of its efforts to ensure that only quality drug materials are sourced by Indian companies from abroad.
This will be the second auditing and inspection of manufacturing facilities in China as the ministry earlier in May this year had sent a three-member CSDCO delegation to inspect the manufacturing sites there. During that two-week long pilot project from May 9 to 21, the CDSCO delegation had inspected five manufacturing sites in China which have been found to be in good condition.
According to sources in the union health ministry, the process for the second inspection is going on and the ministry will soon send the team to China. The nitty-gritties of the visit such as the number of manufacturing sites to be inspected, the composition of the delegation and the exact date of the visit are being worked out by the ministry and it will be finalised very soon, sources said.
However, sources said that this time also the inspections will be carried 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. Accordingly, the Drug Controller General of India (DCGI) Dr Surinder Singh formed a three-member panel, consisting of Arvind Kukrety, assistant drug controller (CDSCO), S Mannivannan, assistant drugs controller (CDSCO) and Dr AR Singh, director at Regional Drugs Testing Laboratory (RDTL) Chandigarh, for the pilot project.
Source:Pharmabiz
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